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{"sheet":"General Guidance","index":0,"n_rows":27,"n_cols":11,"rows_kept":27,"cut":false,"hidden":false,"merged":[[22,6,22,9],[22,10,22,27],[19,1,19,28],[21,2,21,5],[21,6,21,9],[21,10,21,27],[20,1,20,28],[3,1,3,28],[4,2,4,28],[6,2,6,28],[7,2,7,28],[8,2,8,28],[9,2,9,28],[5,2,5,27],[12,2,12,28],[13,2,13,28],[14,2,14,28],[10,2,10,28],[11,2,11,28],[16,2,16,28],[18,1,18,28],[15,2,15,28],[26,2,26,5],[26,6,26,9],[26,10,26,27],[23,2,23,5],[23,6,23,9],[23,10,23,27],[25,2,25,5],[25,6,25,9],[25,10,25,27],[24,2,24,5],[24,6,24,9],[24,10,24,27],[22,2,22,5]]}
[]
[]
[]
[null,"About the amendment tool:"]
[null,"•","The amendment tool may be updated from time to time. Always use the most recent version of the amendment tool available in IRAS help.  "]
[null,"•","A brief training video introducing the amendment tool and its functionality can be accessed on the HRA’s Learning Management System. You will need to register for an account in order to access the video, and we recommend that you click ‘Enrol’ before watching and click ‘Complete’ once finished to create a record of your learning."]
[null,"•","To minimise duplication, the amendment tool should be submitted in place of the Notification of Substantial Amendment form and the Non-Substantial amendment form. If an Annex 2 form is required for a substantial amendment to a CTIMP, the \"Annex 2\" tab  will assist in completing this form based on the answers entered into the amendment tool."]
[null,"•","The amendment tool can be used for all amendments to all types of studies. The completed amendment tool and amended documents should be submitted as directed on the \"Submission Guidance\" tab. The amendment tool is not currently intended to be used for amendments to research tissue banks and research databases. Up to 10 individual changes can be input into the tool. "]
[null,"•","The amendment tool should be completed in order, starting with section 1. All mandatory fields (*) must be completed. The amendment tool cannot be locked for submission until all mandatory fields have been completed. If using the amendment tool to create an Annex 2 form for a substantial amendment to a CTIMP, complete the \"Amendment Tool\" tab before completing the \"Annex 2\" tab. The \"Glossary of Amendment Options\" tab provides a listing of all menu items to assist in identifying the right item to select when completing the tool."]
[null,"•","The Sponsor or authorised delegate is responsible for ensuring that the amendment tool is completed correctly and for comparing the outcomes against their own expectations of how the amendment should be processed. In the event of any discrepancies, the Sponsor or authorised delegate is responsible for determining the substantiality and categorisation for the amendment, and ensuring it is submitted to the relevant review bodies based on the regulations and guidance. If the Sponsor or authorised delegate is still unclear, please contact the relevant review bodies for advice."]
[null,"•","The amendment tool is not currently compliant with the Web Content Accessibility Guidelines version 2.1 AA standard for use with a screen reader. In the longer term we hope to move this over to a new digital platform and make it fully accessible. In the interim period, if you need help in accessing this tool"]
[null,null,"please email amendments@hra.nhs.uk"]
[null,"•","For queries on how to complete the tool or questions on the results from the tool, once complete, contact:"]
[null,null,"For England and Wales led studies: amendments@hra.nhs.uk"]
[null,null,"For Scotland led studies: gram.nrspcc@nhs.scot"]
[null,null,"For Northern Ireland led studies: Research.Amendments@hscni.net"]
[null,"•","The amendment tool is being rolled out as part of a new process for processing amendments. If you would like to provide feedback on the new process, please complete the online Amendment Process Survey."]
[]
[]
[null,"Change record"]
[]
[null,null,"Version number",null,null,null,"Date",null,null,null,"Reason for change"]
[null,null,"1.0",null,null,null,"2020-05-15",null,null,null,"Initial release"]
[null,null,"1.1",null,null,null,"2020-05-22",null,null,null,"Updated review body requirements for \"ionising radiation exposure not involving Radioactive Substances\" options - removed ARSAC review for these changes as requested by ARSAC. Minor update to the \"Submission Guidance\" regarding submission of substantial amendments to CTIMPs in the CWoW pilot. Resolved an issue preventing the \"Lock for submission\" function from working correctly in the \"Amendment Tool\"."]
[null,null,"1.2",null,null,null,"2020-06-11",null,null,null,"\"Amendment Tool\" changes: increased the size and character limit on all free text boxes; resolved an issue affecting the Part 1/Part 2 determinations for CWoW amendments. \"Submission Guidance\" changes: clarification that category C amendments need to be submitted and may require regulatory reviews prior to implementation; updated ARSAC section to state that the completed Amendment Tool should be provided to ARSAC if their review is needed for the amendment. \"Glossary of Changes\" updates: updated the text to match the options in the \"Amendment Tool\". \"Annex 2\" changes: row headings made visible by default to make it easier to adjust the row height; added functionality to add rows to section F; included hyperlinks to the original EudraLex guidance which is referred to throughout; added option to insert digital signature image.  Corrected internal references to the \"CTIMP IMP\", \"CTIMP safety\", \"Participant Procedures\" and \"Stop or Restart\" areas which was causing some options to display incorrect outcomes. Minor formatting changes and corrections to typographical errors."]
[null,null,"1.3",null,null,null,"2020-11-17",null,null,null,"\"Amendment Tool\" changes: greatly increased character limit on all free text boxes, which now also adapt to the amount of text entered; prompt for free text aligned with the wording from the previous Notice of Substantial Amendment form to encourage completion in the same level of detail; resolved an issue in section 2 so that the questions about affected organisations appear based on the selections in section 1 for NHS/HSC and non-NHS/HSC organisations; removed most of the colours following feedback that this made it difficult to read the text; fixed calculation errors affecting the UKSW Governance and HSC Data Guardians columns; added a link to help users navigate to the online submission portal; additional guidance notes on some questions to help users select the appropriate answers. \"Submission Guidance\" updates: minor updates to the guidance for studies with multiple participating organisations in Scotland and Northern Ireland. \"Glossary of Changes\" updates: renamed to \"Glossary of Amendment Options\", updated to reflect the current options available in the tool, added some additional guidance notes. Moved and combined the \"CTIMP documents\" options with \"Study documents\" options, so all that document changes can be found together regardless of study type; updated some of the specific options to reflect REC positions more accurately."]
[null,null,"1.4",null,null,null,"2020-11-30",null,null,null,"\"Amendment Tool\" changes: fixed calculation errors affecting the REC coluumn for outcomes after change 1."]

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[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"For office use",null,null,null,1,null,null,"E/W","S","NI"]
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[null,"Section 1: Project information",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,"Short project title*:",null,null,null,null,null,null,null,null,null,"Predict and prevent ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1,null,null,null,null,null,null,null,null,{"$f":"IF($M$6<>\"\",1,0)","v":1}]
[null,null,"IRAS project ID* (or REC reference if no IRAS project ID is available):",null,null,null,null,null,null,null,null,null,261576,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1,null,null,null,{"$f":"SUBSTITUTE($M$7,\"/\",\"-\")","v":"261576"},null,null,null,null,{"$f":"IF($M$7<>\"\",1,0)","v":1}]
[null,null,"Sponsor amendment reference number*:",null,null,null,null,null,null,null,null,null,"Substantial amendment 03",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1,null,null,null,null,null,null,null,null,{"$f":"IF($M$8<>\"\",1,0)","v":1}]
[null,null,"Sponsor amendment date* (enter as DD/MM/YY):",null,null,null,null,null,null,null,null,null,"2021-02-22",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1,null,null,null,null,null,null,null,null,{"$f":"IF($M$9<>\"\",1,0)","v":1}]
[null,null,"Briefly summarise in lay language the main changes proposed in this amendment. Explain the purpose of the changes and their significance for the study. If the amendment significantly alters the research design or methodology, or could otherwise affect the scientific value of the study, supporting scientific information should be given (or enclosed separately). Indicate whether or not additional scientific critique has been obtained (note: this field will adapt to the amount of text entered)*:",null,null,null,null,null,null,null,null,null,"I am writing on behalf of the Chief Investigator, Professor Alice Turner, to inform you of a substantial amendment.\nThe documents that have been added in the SA03 are listed below…                                            1. This amendment is to clarify that patients can be recruited from patients homes and clinic as opposed to just in clinic. The protocol and PIS has been amended to reflect this.\n\n2. In addition to this the predict and prevent trial underwent a data protection audit which meant the PIS and Protocol needed to be amended so they match and are more clear about the movement of patient data. \n\n3.\tLast amendments made were due to the heavy reference to MHRA and medical device trials in the protocol. As you know the app is already CE marked and under the advice of MHRA and HRA the predict and prevent trial is classed as a non-IMP trial. Therefore, said references have been removed or replaced. ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1,{"$f":"LEN($M$10)","v":920},{"$f":"COUNTIF(AS10:AS49,1)*90","v":450},{"$f":"AP49-AG10","v":3150},null,null,null,null,null,{"$f":"IF($M$10<>\"\",1,0)","v":1},1,{"$f":"AO10*90","v":90},{"$f":"IF(ISNUMBER(FIND(CHAR(10),$M$10,1)),(FIND(CHAR(10),$M$10,1)),0)","v":116},{"$f":"IF(ISNUMBER(FIND(CHAR(13),$M$10,1)),(FIND(CHAR(13),$M$10,1)),0)","v":0},{"$f":"IF(OR(AQ10>0,AR10>0),1,0)","v":1},1,{"$f":"SUM(COUNTIF(AS10:AS49,1),COUNTIF(AT10:AT49,1))","v":16}]
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[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,null,null,null,null,40,3600,{"$f":"IF(AQ48=0,0,IF(ISNUMBER(FIND(CHAR(10),$M$10,SUM(1,AQ48))),(FIND(CHAR(10),$M$10,SUM(1,AQ48))),0))","v":0},0,0,0]
[null,null,"Project type (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1,1]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
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[null,null,"Has the study been reviewed by a UKECA-recognised Research Ethics Committee (REC) prior to this amendment?:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AF$50=1,1,0)","v":1},1]
[null,null,"Is review by a UKECA-recognised Research Ethics Committee (REC) being sought for the first time because of this amendment?:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$53=1,$AF$53=2),1,0)","v":0},2]
[null,null,"What type of UKECA-recognised Research Ethics Committee (REC) review is applicable? (select):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AF$50<>1,0,IF(OR($AF$53=1,$AF$54=1),1,0))","v":1},1]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$55","v":1}]
[null,null,"Is all or part of this amendment being resubmitted to the Research Ethics Committee (REC) as a modified amendment (i.e. a substantial amendment previously given an unfavourable opinion)?",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$58","v":1},2]
[null,null,"Where is the NHS/HSC Research Ethics Committee (REC) that reviewed the study based?:",null,null,null,null,null,null,null,null,null,null,null,null,null,"England",null,null,"Wales",null,null,"Scotland",null,null,"Northern Ireland",null,null,null,null,{"$f":"IF(AND($AF$50=1,$AF$53=1,$AF$55=1),1,0)","v":1}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$58","v":1},1]
[null,null,"Was the study a clinical trial of an investigational medicinal product (CTIMP) OR does the amendment make it one?:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AF$50=1,$AF$53=1),1,0)","v":1},2]
[null,null,"Was this clinical trial of an investigational medicinal product (CTIMP) processed under the Combined Ways of Working (CWoW) pilot?:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$60=1,$AF$60=1),1,0)","v":0},2]
[null,null,"Did the study receive Pharmacy Assurance?:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$60=1,$AF$60=1),1,0)","v":0},2]
[null,null,"Was the study a clinical investigation or other study of a medical device OR does the amendment make it one?:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AF$50=1,$AF$53=1),1,0)","v":1},2]
[null,null,"Does this clinical investigation or other study of a medical device require a Notice of No Objection from MHRA Devices?:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$63=1,$AF$63=1),1,0)","v":0},2]
[null,null,"Did the study involve the administration of radioactive substances, therefore requiring ARSAC review, OR does the amendment introduce this?:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AF$50=1,$AF$53=1),1,0)","v":1},2]
[null,null,"Did the study involve the use of research exposures to ionising radiation (not involving the administration of radioactive substances) OR does the amendment introduce this?:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AF$50=1,$AF$53=1),1,0)","v":1},2]
[null,null,"Did the study have Radiation Assurance OR is Radiation Assurance being sought for the first time because of this amendment?:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$66=1,OR($AF$65=1,$AF$66=1)),1,0)","v":0},2]
[null,null,"Did the study involve adults lacking capacity OR does the amendment introduce this?:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AF$50<>1,0,IF($AF$53=1,1,0))","v":1},2]
[null,null,"Did the study involve access to confidential patient information outside the direct care team without consent OR does the amendment introduce this?:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AF50<>1,0,IF($AF$53=1,1,0))","v":1},2]
[null,null,"Did the study involve prisoners OR does the amendment introduce this?:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AF50<>1,0,IF($AF$53=1,1,0))","v":1},2]
[null,null,"Did the study involve NHS/HSC organisations prior to this amendment?:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AF$50=1,1,0)","v":1},1]
[null,null,"Are NHS/HSC organisations being added for the first time because of this amendment?:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AF$50<>1,0,IF(AND($AE$71=1,$AF$71=1),0,1))","v":0},2]
[null,null,"Did the study involve non-NHS/HSC organisations OR does the amendment introduce them?:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AF$50<>1,0,1)","v":1},2]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"England",null,null,"Wales",null,null,"Scotland",null,null,"Northern Ireland",null,null,null,null,{"$f":"IF(OR(AE75:AE81=1),1,0)","v":1}]
[null,null,"Lead nation for the study:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$71=1,$AF$71=1),1,IF(AND($AE$72=1,$AF$72=1),1,0))","v":1},1,null,null,null,"E","W","S","NI"]
[null,null,"Which nations had participating NHS/HSC organisations prior to this amendment?",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$75","v":1},true,false,false,false,{"$f":"IF(AND($AE$60=1,$AF$60=1),0,IF(AND($AE$68=1,$AF$68=1),1,0))","v":0},null,null,null,{"$f":"IF(AND($AE$71=1,$AF$71=1,$AF$76:$AI$76=FALSE),0,1)","v":1}]
[null,null,"Which nations will have participating NHS/HSC organisations after this amendment?",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$75","v":1},{"$f":"AF76","v":true},false,false,false,{"$f":"IF(AND($AJ$76=1,AF76=FALSE,AF80=FALSE)*OR(AF77=TRUE,AO143=1),1,0)","v":0},{"$f":"IF(AND($AJ$76=1,AG76=FALSE,AG80=FALSE)*OR(AG77=TRUE,AP143=1),1,0)","v":0},{"$f":"IF(AND($AJ$76=1,AH76=FALSE,AH80=FALSE)*OR(AH77=TRUE,AQ143=1),1,0)","v":0},{"$f":"IF(AND($AJ$76=1,AI76=FALSE,AI80=FALSE)*OR(AI77=TRUE,AR143=1),1,0)","v":0},{"$f":"IF(AND($AE$72=1,$AF$72=1,$AF$77:$AI$77=FALSE),0,1)","v":1},{"$f":"IF(AND($AF$59=3,$AJ$76=1,AF76=FALSE,AF80=FALSE)*OR(AF77=TRUE,AO143=1),1,0)","v":0},{"$f":"IF(AND($AF$59=3,$AJ$76=1,AG76=FALSE,AG80=FALSE)*OR(AG77=TRUE,AP143=1),1,0)","v":0},{"$f":"IF(AND($AF$59<>3,$AJ$76=1,AH76=FALSE,AH80=FALSE)*OR(AH77=TRUE,AQ143=1),1,0)","v":0},{"$f":"IF(AND($AF$59=3,$AJ$76=1,AI76=FALSE,AI80=FALSE)*OR(AI77=TRUE,AR143=1),1,0)","v":0}]
[null,null,"Does this study only involve a single participating NHS organisation in Scotland?",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$75=1,$AH$78=1),1,0)","v":0},2,null,{"$f":"IF(AND($AF$76=FALSE,$AF$77=FALSE,$AG$76=FALSE,$AG$77=FALSE,$AH$76=TRUE,$AH$77=TRUE,$AI$76=FALSE,$AI$77=FALSE),1,0)","v":0}]
[null,null,"Does this study only involve a single participating HSC organisation in Northern Ireland?",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$75=1,$AI$79=1),1,0)","v":0},2,null,null,{"$f":"IF(AND($AF$76=FALSE,$AF$77=FALSE,$AG$76=FALSE,$AG$77=FALSE,$AH$76=FALSE,$AH$77=FALSE,$AI$76=TRUE,$AI$77=TRUE),1,0)","v":0}]
[null,null,"Which nations had participating non-NHS/HSC organisations prior to this amendment?",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$73=1,$AF$73=1),1,0)","v":0},false,false,false,false,null,null,null,null,{"$f":"IF(AND($AE$73=1,$AF$73=1,AF80:AI81=FALSE),0,1)","v":1}]
[null,null,"Which nations will have participating non-NHS/HSC organisations after this amendment?",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$80","v":0},{"$f":"AF80","v":false},false,false,false,null,null,null,null,null,{"$f":"IF(AND($AF$59=3,$AJ$76=1,AF80=FALSE)*OR(AF81=TRUE,AF146=TRUE,AF195=TRUE,AF244=TRUE,AF293=TRUE,AF342=TRUE,AF391=TRUE,AF440=TRUE,AF489=TRUE,AF538=TRUE,AF587=TRUE),1,0)","v":0},{"$f":"IF(AND($AF$59=3,$AJ$76=1,AG80=FALSE)*OR(AG81=TRUE,AG146=TRUE,AG195=TRUE,AG244=TRUE,AG293=TRUE,AG342=TRUE,AG391=TRUE,AG440=TRUE,AG489=TRUE,AG538=TRUE,AG587=TRUE),1,0)","v":0},{"$f":"IF(AND($AF$59<>3,$AJ$76=1,AH80=FALSE)*OR(AH81=TRUE,AH146=TRUE,AH195=TRUE,AH244=TRUE,AH293=TRUE,AH342=TRUE,AH391=TRUE,AH440=TRUE,AH489=TRUE,AH538=TRUE,AH587=TRUE),1,0)","v":0},{"$f":"IF(AND($AF$59=3,$AJ$76=1,AI80=FALSE)*OR(AI81=TRUE,AI146=TRUE,AI195=TRUE,AI244=TRUE,AI293=TRUE,AI342=TRUE,AI391=TRUE,AI440=TRUE,AI489=TRUE,AI538=TRUE,AI587=TRUE),1,0)","v":0}]
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[null,"Due to the complex nature of this change, please seek individual advice on how to handle this amendment by emailing amendments@hra.nhs.uk",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(AND($AE$54=1,$AF$54=1,$AF$55=1),(AND($AE$72=1,$AF$72=1))),1,0)","v":0}]
[null,"Due to the complex nature of this change, please seek individual advice on how to handle this amendment by emailing modrec@mail.dstl.gov.uk",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$54=1,$AF$54=1,$AF$55=2),1,0)","v":0}]
[null,"Please note: The amendment tool is not currently intended for processing amendments to research tissue banks. Please use the forms available in IRAS to submit the amendment.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AF$50=2,1,0)","v":0}]
[null,"Please note: The amendment tool is not currently intended for processing amendments to research databases. Please use the forms available in IRAS to submit the amendment.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AF$50=3,1,0)","v":0}]
[null,"Please note: The answers above indicate that there are no participting NHS/HSC or non-NHS/HSC organisations for this study in any of the UK nations. There must be at least one participating organisation in order to amend the study taking place there. Please check to ensure that the answers above accurately reflect the situation for the study.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(AE84:AE87=1),0,IF(OR(AND(AE76=0,AE77=0,AE80=0,AE81=0),AND(AF76:AI77=FALSE,AF80:AI81=FALSE)),1,0))","v":0}]
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[null,"Section 2: Summary of change(s)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR($AE$84=1,AE85=1,AE86=1,AE87=1,AE88=1),0,1)","v":1}]
[null,null,"What do you want to update?:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$90=0,0,IF(AND($AE$61=1,$AF$61=1),1,0))","v":0},4,{"$f":"IF(OR($AE$91=1,$AE$92=1,$AE$93=1,$AE$94=1,$AE$95=1),1,0)","v":0}]
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[null,null,"Please note: When you are updating key project parties, you will not be able to create further amendments until the key parties are approved.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$90=0,0,IF(AND($AE$91=1,$AF$91<3),1,0))","v":0}]
[null,null,"Please note: Only use this option when updating key contact changes for Sponsor or Legal Representatives.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$90=0,0,IF(AND($AE$91=1,$AF$91=3),1,0))","v":0}]
[null,null,"Please note: Only use this option when adding a new site or Principal Investigator (PI) to a clinical trial of an investigational medicinal product (CTIMP). You will not be able to make any other changes at the same time.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$90=0,0,IF(AND($AE$95=1,$AF$91=5),1,0))","v":0}]
[null,null,"Please note: Each change being made as part of the amendment must be entered separately. For example, if an amendment to a clinical trial of an investigational medicinal product (CTIMP) involves an update to the Investigator's Brochure (IB), affecting the Reference Safety Information (RSI) and so the information documents to be given to participants, these should be entered into the amendment tool as three separate changes. A list of all possible changes is available on the \"Glossary of Amendment Options\" tab. To add another change, tick the \"Add another change\" box.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$90=0,0,IF(AND($AE$96=0,$AE$97=0),1,0))","v":1},{"$f":"IF($AE$90=0,0,IF(AND($AE$91=0,$AE$92=0,$AE$93=0,$AE$94=0,$AE$95=0),0,IF(AND($AE$96=0,$AE$97=0,$AE$98=0),1,0)))","v":0}]
[null,null,"Change 1",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$90","v":1}]
[null,null,"Area of change (select)*:",null,null,null,null,null,null,null,null,null,"Participant Procedures ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$90=0,0,IF($AE$91=0,1,IF(AND($AE$91=1,$AF$91=4),1,0)))","v":1},null,{"$f":"IF($M$101=\"\",1,IF($AE$101=0,1,IF(COUNTIF(Area_18,$M$101)=1,1,0)))","v":1},{"$f":"IF(AND($AE$91=1,$AF$91=1),'Menu Data'!$A$15,IF(AND($AE$91=1,$AF$91=2),'Menu Data'!$A$19,IF(AND($AE$91=1,$AF$91=3),'Menu Data'!$A$2,$M$101)))","v":"Participant Procedures "},null,null,null,null,null,{"$f":"IF(AH101<>0,1,0)","v":1}]
[null,null,"Specific change (select - only available when area of change is selected first)*:",null,null,null,null,null,null,null,null,null,"Participant procedures - minor change that can be implemented within existing resource at participating organisations - Please specify in the free text below",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$90=0,0,IF($AE$91=0,1,IF(AND($AE$91=1,$AF$91=4),1,0)))","v":1},{"$f":"IF($M$102=\"\",1,(IF($M$101=\"\",1,IF($AE$102=0,1,IF(COUNTIF(INDIRECT($AG$102),$M$102),1,0)))))","v":1},{"$f":"VLOOKUP($M101,Arrays!$A$31:$H$48,8)","v":"Participant_Procedures_8"},{"$f":"IF(AND($AE$91=1,$AF$91=1),'Menu Data'!$C$107,IF(AND($AE$91=1,$AF$91=2),'Menu Data'!$C$179,IF(AND($AE$91=1,$AF$91=3),'Menu Data'!$C$6,$M$102)))","v":"Participant procedures - minor change that can be implemented within existing resource at participating organisations - Please specify in the free text below"},null,null,null,null,null,{"$f":"IF(AH102<>0,1,0)","v":1}]
[null,null,"Further information (free text - note that this field will adapt to the amount of text entered):",null,null,null,null,null,null,null,null,null,"This amendment is to clarify that patients can be recruited/ attend assessment appointments from patients homes and clinic as opposed to just in clinic. The protocol and PIS has been amended to reflect this.\n\n",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$90","v":1},{"$f":"LEN($M$103)","v":209},{"$f":"COUNTIF(AS103:AS142,1)*90","v":180},{"$f":"AP142-AG103","v":3420},null,null,null,null,null,null,1,{"$f":"AO103*90","v":90},{"$f":"IF(ISNUMBER(FIND(CHAR(10),$M$103,1)),(FIND(CHAR(10),$M$103,1)),0)","v":208},{"$f":"IF(ISNUMBER(FIND(CHAR(13),$M$103,1)),(FIND(CHAR(13),$M$103,1)),0)","v":0},{"$f":"IF(OR(AQ103>0,AR103>0),1,0)","v":1},1,{"$f":"SUM(COUNTIF(AS103:AS142,1),COUNTIF(AT103:AT142,1))","v":5}]
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[null,null,"Applicability:",null,null,null,null,null,null,null,null,null,null,null,null,null,"England",null,null,"Wales",null,null,"Scotland",null,null,"Northern Ireland",null,null,null,null,{"$f":"$AE$90","v":1},null,null,null,null,{"$f":"IF(AND(AJ144:AM144=FALSE,AJ193:AM193=FALSE,AJ242:AM242=FALSE,AJ291:AM291=FALSE,AJ340:AM340=FALSE,AJ389:AM389=FALSE,AJ438:AM438=FALSE,AJ487:AM487=FALSE,AJ536:AM536=FALSE,AJ585:AM585=FALSE),0,1)","v":1},null,null,null,null,{"$f":"IF(COUNTIF(AO144:AO587,1),1,0)","v":1},{"$f":"IF(COUNTIF(AP144:AP587,1),1,0)","v":0},{"$f":"IF(COUNTIF(AQ144:AQ587,1),1,0)","v":1},{"$f":"IF(COUNTIF(AR144:AR587,1),1,0)","v":0}]
[null,null,"Where are the participating NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$90=0,0,IF(OR(AND($AE$76=0,$AE$77=0),AND($AF$76:$AI$77=FALSE)),0,1))","v":1},{"$f":"$AF$77","v":true},{"$f":"$AG$77","v":false},{"$f":"$AH$77","v":false},{"$f":"$AI$77","v":false},{"$f":"IF($AE$144=0,FALSE,$AF$144)","v":true},{"$f":"IF($AE$144=0,FALSE,$AG$144)","v":false},{"$f":"IF($AE$144=0,FALSE,$AH$144)","v":false},{"$f":"IF($AE$144=0,FALSE,$AI$144)","v":false},{"$f":"IF(AE144=0,1,IF(AND($AJ$144:$AM$146=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$76=FALSE,AJ144=TRUE)*OR('Amendment Tool'!$M102='Menu Data'!$C$83,'Amendment Tool'!$M102='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$76=FALSE,AK144=TRUE)*OR('Amendment Tool'!$M102='Menu Data'!$C$83,'Amendment Tool'!$M102='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$76=FALSE,AL144=TRUE)*OR('Amendment Tool'!$M102='Menu Data'!$C$83,'Amendment Tool'!$M102='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$76=FALSE,AM144=TRUE)*OR('Amendment Tool'!$M102='Menu Data'!$C$83,'Amendment Tool'!$M102='Menu Data'!$C$84),1,0)","v":0}]
[null,null,"Will all participating NHS/HSC organisations be affected by this change, or only some? (please note that this answer may affect the categorisation for the change):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$144=0,0,IF(AND($AE$144=1,OR($AJ$144=TRUE,$AK$144=TRUE,$AL$144=TRUE,$AM$144=TRUE)),1,0))","v":1},1]
[null,null,"Where are the participating non-NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$90=0,0,IF(OR($AE$73<>1,$AF$73<>1),0,IF(AND($AF$80:$AI$81=FALSE),0,1)))","v":0},{"$f":"$AF$81","v":false},{"$f":"$AG$81","v":false},{"$f":"$AH$81","v":false},{"$f":"$AI$81","v":false},{"$f":"IF($AE$146=0,FALSE,$AF$146)","v":false},{"$f":"IF($AE$146=0,FALSE,$AG$146)","v":false},{"$f":"IF($AE$146=0,FALSE,$AH$146)","v":false},{"$f":"IF($AE$146=0,FALSE,$AI$146)","v":false},{"$f":"IF(AE146=0,1,IF(AND($AJ$144:$AM$146=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$80=FALSE,AJ146=TRUE)*OR('Amendment Tool'!$M143='Menu Data'!$C$83,'Amendment Tool'!$M143='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$80=FALSE,AK146=TRUE)*OR('Amendment Tool'!$M143='Menu Data'!$C$83,'Amendment Tool'!$M143='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$80=FALSE,AL146=TRUE)*OR('Amendment Tool'!$M143='Menu Data'!$C$83,'Amendment Tool'!$M143='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$80=FALSE,AM146=TRUE)*OR('Amendment Tool'!$M143='Menu Data'!$C$83,'Amendment Tool'!$M143='Menu Data'!$C$84),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Add another change:",null,null,null,null,null,null,null,{"$f":"IF($AE$90=0,0,IF($AE$91=0,1,IF(AND($AE$91=1,$AF$91=4),1,0)))","v":1},true,{"$f":"IF($AE$147=0,FALSE,$AF$147)","v":true}]
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[null,null,"Change 2",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AG$147=TRUE,1,0)","v":1}]
[null,null,"Area of change (select)*:",null,null,null,null,null,null,null,null,null,"Study Documents ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$149","v":1},null,{"$f":"IF($M$150=\"\",1,IF(COUNTIF(Area_18,$M$150)=1,1,0))","v":1},null,null,null,null,null,null,{"$f":"IF(AE150=0,1,IF(M150<>\"\",1,0))","v":1}]
[null,null,"Specific change (select - only available when area of change is selected first)*:",null,null,null,null,null,null,null,null,null,"Protocol - Substantial changes (e.g. affecting safety or the scientific value of the trial)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$149","v":1},{"$f":"IF($M$151=\"\",1,(IF($M$150=\"\",1,IF($AE$151=0,1,IF(COUNTIF(INDIRECT($AG$151),$M$151),1,0)))))","v":1},{"$f":"VLOOKUP($M150,Arrays!$A$31:$H$48,8)","v":"Study_Documents_12"},null,null,null,null,null,null,{"$f":"IF(AE151=0,1,IF(M151<>\"\",1,0))","v":1}]
[null,null,"Further information (free text - note that this field will adapt to the amount of text entered):",null,null,null,null,null,null,null,null,null,"\nAmendments made were due to the heavy reference to MHRA and medical device trials in the protocol. As the app is already CE marked and under the advice of MHRA and HRA the predict and prevent trial is classed as a non-IMP trial. Therefore, said references have been removed or replaced.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$149","v":1},{"$f":"LEN($M$152)","v":287},{"$f":"COUNTIF(AS152:AS191,1)*90","v":90},{"$f":"AP191-AG152","v":3510},null,null,null,null,null,null,1,{"$f":"AO152*90","v":90},{"$f":"IF(ISNUMBER(FIND(CHAR(10),$M$152,1)),(FIND(CHAR(10),$M$152,1)),0)","v":1},{"$f":"IF(ISNUMBER(FIND(CHAR(13),$M$152,1)),(FIND(CHAR(13),$M$152,1)),0)","v":0},{"$f":"IF(OR(AQ152>0,AR152>0),1,0)","v":1},1,{"$f":"SUM(COUNTIF(AS152:AS191,1),COUNTIF(AT152:AT191,1))","v":5}]
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[null,null,"Applicability:",null,null,null,null,null,null,null,null,null,null,null,null,null,"England",null,null,"Wales",null,null,"Scotland",null,null,"Northern Ireland",null,null,null,null,{"$f":"$AE$149","v":1}]
[null,null,"Where are the participating NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$71=1,$AF$71=1,$AG$147=TRUE),$AE$144,0)","v":1},{"$f":"$AF$77","v":true},{"$f":"$AG$77","v":false},{"$f":"$AH$77","v":false},{"$f":"$AI$77","v":false},{"$f":"IF($AE$193=0,FALSE,$AF$193)","v":true},{"$f":"IF($AE$193=0,FALSE,$AG$193)","v":false},{"$f":"IF($AE$193=0,FALSE,$AH$193)","v":false},{"$f":"IF($AE$193=0,FALSE,$AI$193)","v":false},{"$f":"IF(AE193=0,1,IF(AND($AJ$193:$AM$195=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$76=FALSE,AJ193=TRUE)*OR('Amendment Tool'!$M151='Menu Data'!$C$83,'Amendment Tool'!$M151='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$76=FALSE,AK193=TRUE)*OR('Amendment Tool'!$M151='Menu Data'!$C$83,'Amendment Tool'!$M151='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$76=FALSE,AL193=TRUE)*OR('Amendment Tool'!$M151='Menu Data'!$C$83,'Amendment Tool'!$M151='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$76=FALSE,AM193=TRUE)*OR('Amendment Tool'!$M151='Menu Data'!$C$83,'Amendment Tool'!$M151='Menu Data'!$C$84),1,0)","v":0}]
[null,null,"Will all participating NHS/HSC organisations be affected by this change, or only some? (please note that this answer may affect the categorisation for the change):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$193=0,0,IF(AND($AE$193=1,OR($AJ$193=TRUE,$AK$193=TRUE,$AL$193=TRUE,$AM$193=TRUE)),1,0))","v":1},1]
[null,null,"Where are the participating non-NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$73=1,$AF$73=1,$AG$147=TRUE),$AE$146,0)","v":0},{"$f":"$AF$81","v":false},{"$f":"$AG$81","v":false},{"$f":"$AH$81","v":false},{"$f":"$AI$81","v":false},{"$f":"IF($AE$195=0,FALSE,$AF$195)","v":false},{"$f":"IF($AE$195=0,FALSE,$AG$195)","v":false},{"$f":"IF($AE$195=0,FALSE,$AH$195)","v":false},{"$f":"IF($AE$195=0,FALSE,$AI$195)","v":false},{"$f":"IF(AE195=0,1,IF(AND($AJ$193:$AM$195=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$80=FALSE,AJ195=TRUE)*OR('Amendment Tool'!$M192='Menu Data'!$C$83,'Amendment Tool'!$M192='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$80=FALSE,AK195=TRUE)*OR('Amendment Tool'!$M192='Menu Data'!$C$83,'Amendment Tool'!$M192='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$80=FALSE,AL195=TRUE)*OR('Amendment Tool'!$M192='Menu Data'!$C$83,'Amendment Tool'!$M192='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$80=FALSE,AM195=TRUE)*OR('Amendment Tool'!$M192='Menu Data'!$C$83,'Amendment Tool'!$M192='Menu Data'!$C$84),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Add another change:",null,null,null,null,null,null,null,{"$f":"$AE$149","v":1},true,{"$f":"IF($AE$196=0,FALSE,$AF$196)","v":true}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$149","v":1}]
[null,null,"Change 3",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AG$196=TRUE,1,0)","v":1}]
[null,null,"Area of change (select)*:",null,null,null,null,null,null,null,null,null,"Study Documents ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$198","v":1},null,{"$f":"IF($M$199=\"\",1,IF(COUNTIF(Area_18,$M$199)=1,1,0))","v":1},null,null,null,null,null,null,{"$f":"IF(AE199=0,1,IF(M199<>\"\",1,0))","v":1}]
[null,null,"Specific change (select - only available when area of change is selected first)*:",null,null,null,null,null,null,null,null,null,"Other minor change to study documents (e.g. information sheets, consent forms, questionnaires, letters) that can be implemented within existing resource in place at participating organisations - Please specify in the free text below",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$198","v":1},{"$f":"IF($M$200=\"\",1,(IF($M$199=\"\",1,IF($AE$200=0,1,IF(COUNTIF(INDIRECT($AG$200),$M$200),1,0)))))","v":1},{"$f":"VLOOKUP($M199,Arrays!$A$31:$H$48,8)","v":"Study_Documents_12"},null,null,null,null,null,null,{"$f":"IF(AE200=0,1,IF(M200<>\"\",1,0))","v":1}]
[null,null,"Further information (free text - note that this field will adapt to the amount of text entered):",null,null,null,null,null,null,null,null,null,"The predict and prevent trial underwent a data protection audit which meant the PIS and Protocol needed to be amended so they match and are more clear about the movement of patient data. \n\n",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$198","v":1},{"$f":"LEN($M$201)","v":189},{"$f":"COUNTIF(AS201:AS240,1)*90","v":180},{"$f":"AP240-AG201","v":3420},null,null,null,null,null,null,1,{"$f":"AO201*90","v":90},{"$f":"IF(ISNUMBER(FIND(CHAR(10),$M$201,1)),(FIND(CHAR(10),$M$201,1)),0)","v":188},{"$f":"IF(ISNUMBER(FIND(CHAR(13),$M$201,1)),(FIND(CHAR(13),$M$201,1)),0)","v":0},{"$f":"IF(OR(AQ201>0,AR201>0),1,0)","v":1},1,{"$f":"SUM(COUNTIF(AS201:AS240,1),COUNTIF(AT201:AT240,1))","v":5}]
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[null,null,"Applicability:",null,null,null,null,null,null,null,null,null,null,null,null,null,"England",null,null,"Wales",null,null,"Scotland",null,null,"Northern Ireland",null,null,null,null,{"$f":"$AE$198","v":1}]
[null,null,"Where are the participating NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$71=1,$AF$71=1,$AG$196=TRUE),$AE$144,0)","v":1},{"$f":"$AF$77","v":true},{"$f":"$AG$77","v":false},{"$f":"$AH$77","v":false},{"$f":"$AI$77","v":false},{"$f":"IF($AE$242=0,FALSE,$AF$242)","v":true},{"$f":"IF($AE$242=0,FALSE,$AG$242)","v":false},{"$f":"IF($AE$242=0,FALSE,$AH$242)","v":false},{"$f":"IF($AE$242=0,FALSE,$AI$242)","v":false},{"$f":"IF(AE242=0,1,IF(AND($AJ$242:$AM$244=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$76=FALSE,AJ242=TRUE)*OR('Amendment Tool'!$M200='Menu Data'!$C$83,'Amendment Tool'!$M200='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$76=FALSE,AK242=TRUE)*OR('Amendment Tool'!$M200='Menu Data'!$C$83,'Amendment Tool'!$M200='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$76=FALSE,AL242=TRUE)*OR('Amendment Tool'!$M200='Menu Data'!$C$83,'Amendment Tool'!$M200='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$76=FALSE,AM242=TRUE)*OR('Amendment Tool'!$M200='Menu Data'!$C$83,'Amendment Tool'!$M200='Menu Data'!$C$84),1,0)","v":0}]
[null,null,"Will all participating NHS/HSC organisations be affected by this change, or only some? (please note that this answer may affect the categorisation for the change):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$242=0,0,IF(AND($AE$242=1,OR($AJ$242=TRUE,$AK$242=TRUE,$AL$242=TRUE,$AM$242=TRUE)),1,0))","v":1},1]
[null,null,"Where are the participating non-NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$73=1,$AF$73=1,$AG$196=TRUE),$AE$146,0)","v":0},{"$f":"$AF$81","v":false},{"$f":"$AG$81","v":false},{"$f":"$AH$81","v":false},{"$f":"$AI$81","v":false},{"$f":"IF($AE$244=0,FALSE,$AF$244)","v":false},{"$f":"IF($AE$244=0,FALSE,$AG$244)","v":false},{"$f":"IF($AE$244=0,FALSE,$AH$244)","v":false},{"$f":"IF($AE$244=0,FALSE,$AI$244)","v":false},{"$f":"IF(AE244=0,1,IF(AND($AJ$242:$AM$244=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$80=FALSE,AJ244=TRUE)*OR('Amendment Tool'!$M241='Menu Data'!$C$83,'Amendment Tool'!$M241='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$80=FALSE,AK244=TRUE)*OR('Amendment Tool'!$M241='Menu Data'!$C$83,'Amendment Tool'!$M241='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$80=FALSE,AL244=TRUE)*OR('Amendment Tool'!$M241='Menu Data'!$C$83,'Amendment Tool'!$M241='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$80=FALSE,AM244=TRUE)*OR('Amendment Tool'!$M241='Menu Data'!$C$83,'Amendment Tool'!$M241='Menu Data'!$C$84),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Add another change:",null,null,null,null,null,null,null,{"$f":"$AE$198","v":1},false,{"$f":"IF($AE$245=0,FALSE,$AF$245)","v":false}]
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[null,null,"Change 4",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AG$245=TRUE,1,0)","v":0}]
[null,null,"Area of change (select)*:",null,null,null,null,null,null,null,null,null,"Study Design ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$247","v":0},null,{"$f":"IF($M$248=\"\",1,IF(COUNTIF(Area_18,$M$248)=1,1,0))","v":1},null,null,null,null,null,null,{"$f":"IF(AE248=0,1,IF(M248<>\"\",1,0))","v":1}]
[null,null,"Specific change (select - only available when area of change is selected first)*:",null,null,null,null,null,null,null,null,null,"Other significant change to study design that can be implemented within existing resource in place at participating organisations - Please specify in the free text below",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$247","v":0},{"$f":"IF($M$249=\"\",1,(IF($M$248=\"\",1,IF($AE$249=0,1,IF(COUNTIF(INDIRECT($AG$249),$M$249),1,0)))))","v":1},{"$f":"VLOOKUP($M248,Arrays!$A$31:$H$48,8)","v":"Study_Design_17"},null,null,null,null,null,null,{"$f":"IF(AE249=0,1,IF(M249<>\"\",1,0))","v":1}]
[null,null,"Further information (free text - note that this field will adapt to the amount of text entered):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$247","v":0},{"$f":"LEN($M$250)","v":0},{"$f":"COUNTIF(AS250:AS289,1)*90","v":0},{"$f":"AP289-AG250","v":3600},null,null,null,null,null,null,1,{"$f":"AO250*90","v":90},{"$f":"IF(ISNUMBER(FIND(CHAR(10),$M$250,1)),(FIND(CHAR(10),$M$250,1)),0)","v":0},{"$f":"IF(ISNUMBER(FIND(CHAR(13),$M$250,1)),(FIND(CHAR(13),$M$250,1)),0)","v":0},{"$f":"IF(OR(AQ250>0,AR250>0),1,0)","v":0},1,{"$f":"SUM(COUNTIF(AS250:AS289,1),COUNTIF(AT250:AT289,1))","v":1}]
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[null,null,"Applicability:",null,null,null,null,null,null,null,null,null,null,null,null,null,"England",null,null,"Wales",null,null,"Scotland",null,null,"Northern Ireland",null,null,null,null,{"$f":"$AE$247","v":0}]
[null,null,"Where are the participating NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$71=1,$AF$71=1,$AG$245=TRUE),$AE$144,0)","v":0},{"$f":"$AF$77","v":true},{"$f":"$AG$77","v":false},{"$f":"$AH$77","v":false},{"$f":"$AI$77","v":false},{"$f":"IF($AE$291=0,FALSE,$AF$291)","v":false},{"$f":"IF($AE$291=0,FALSE,$AG$291)","v":false},{"$f":"IF($AE$291=0,FALSE,$AH$291)","v":false},{"$f":"IF($AE$291=0,FALSE,$AI$291)","v":false},{"$f":"IF(AE291=0,1,IF(AND($AJ$291:$AM$293=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$76=FALSE,AJ291=TRUE)*OR('Amendment Tool'!$M249='Menu Data'!$C$83,'Amendment Tool'!$M249='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$76=FALSE,AK291=TRUE)*OR('Amendment Tool'!$M249='Menu Data'!$C$83,'Amendment Tool'!$M249='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$76=FALSE,AL291=TRUE)*OR('Amendment Tool'!$M249='Menu Data'!$C$83,'Amendment Tool'!$M249='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$76=FALSE,AM291=TRUE)*OR('Amendment Tool'!$M249='Menu Data'!$C$83,'Amendment Tool'!$M249='Menu Data'!$C$84),1,0)","v":0}]
[null,null,"Will all participating NHS/HSC organisations be affected by this change, or only some? (please note that this answer may affect the categorisation for the change):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$291=0,0,IF(AND($AE$291=1,OR($AJ$291=TRUE,$AK$291=TRUE,$AL$291=TRUE,$AM$291=TRUE)),1,0))","v":0},1]
[null,null,"Where are the participating non-NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$73=1,$AF$73=1,$AG$245=TRUE),$AE$146,0)","v":0},{"$f":"$AF$81","v":false},{"$f":"$AG$81","v":false},{"$f":"$AH$81","v":false},{"$f":"$AI$81","v":false},{"$f":"IF($AE$293=0,FALSE,$AF$293)","v":false},{"$f":"IF($AE$293=0,FALSE,$AG$293)","v":false},{"$f":"IF($AE$293=0,FALSE,$AH$293)","v":false},{"$f":"IF($AE$293=0,FALSE,$AI$293)","v":false},{"$f":"IF(AE293=0,1,IF(AND($AJ$291:$AM$293=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$80=FALSE,AJ293=TRUE)*OR('Amendment Tool'!$M290='Menu Data'!$C$83,'Amendment Tool'!$M290='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$80=FALSE,AK293=TRUE)*OR('Amendment Tool'!$M290='Menu Data'!$C$83,'Amendment Tool'!$M290='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$80=FALSE,AL293=TRUE)*OR('Amendment Tool'!$M290='Menu Data'!$C$83,'Amendment Tool'!$M290='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$80=FALSE,AM293=TRUE)*OR('Amendment Tool'!$M290='Menu Data'!$C$83,'Amendment Tool'!$M290='Menu Data'!$C$84),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Add another change:",null,null,null,null,null,null,null,{"$f":"$AE$247","v":0},false,{"$f":"IF($AE$294=0,FALSE,$AF$294)","v":false}]
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[null,null,"Change 5",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AG$294=TRUE,1,0)","v":0}]
[null,null,"Area of change (select)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$296","v":0},null,{"$f":"IF($M$297=\"\",1,IF(COUNTIF(Area_18,$M$297)=1,1,0))","v":1},null,null,null,null,null,null,{"$f":"IF(AE297=0,1,IF(M297<>\"\",1,0))","v":1}]
[null,null,"Specific change (select - only available when area of change is selected first)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$296","v":0},{"$f":"IF($M$298=\"\",1,(IF($M$297=\"\",1,IF($AE$298=0,1,IF(COUNTIF(INDIRECT($AG$298),$M$298),1,0)))))","v":1},{"$f":"VLOOKUP($M297,Arrays!$A$31:$H$48,8)","v":{"$error":"#N/A"}},null,null,null,null,null,null,{"$f":"IF(AE298=0,1,IF(M298<>\"\",1,0))","v":1}]
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[null,null,"Applicability:",null,null,null,null,null,null,null,null,null,null,null,null,null,"England",null,null,"Wales",null,null,"Scotland",null,null,"Northern Ireland",null,null,null,null,{"$f":"$AE$296","v":0}]
[null,null,"Where are the participating NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$71=1,$AF$71=1,$AG$294=TRUE),$AE$144,0)","v":0},{"$f":"$AF$77","v":true},{"$f":"$AG$77","v":false},{"$f":"$AH$77","v":false},{"$f":"$AI$77","v":false},{"$f":"IF($AE$340=0,FALSE,$AF$340)","v":false},{"$f":"IF($AE$340=0,FALSE,$AG$340)","v":false},{"$f":"IF($AE$340=0,FALSE,$AH$340)","v":false},{"$f":"IF($AE$340=0,FALSE,$AI$340)","v":false},{"$f":"IF(AE340=0,1,IF(AND($AJ$340:$AM$342=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$76=FALSE,AJ340=TRUE)*OR('Amendment Tool'!$M298='Menu Data'!$C$83,'Amendment Tool'!$M298='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$76=FALSE,AK340=TRUE)*OR('Amendment Tool'!$M298='Menu Data'!$C$83,'Amendment Tool'!$M298='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$76=FALSE,AL340=TRUE)*OR('Amendment Tool'!$M298='Menu Data'!$C$83,'Amendment Tool'!$M298='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$76=FALSE,AM340=TRUE)*OR('Amendment Tool'!$M298='Menu Data'!$C$83,'Amendment Tool'!$M298='Menu Data'!$C$84),1,0)","v":0}]
[null,null,"Will all participating NHS/HSC organisations be affected by this change, or only some? (please note that this answer may affect the categorisation for the change):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$340=0,0,IF(AND($AE$340=1,OR($AJ$340=TRUE,$AK$340=TRUE,$AL$340=TRUE,$AM$340=TRUE)),1,0))","v":0},1]
[null,null,"Where are the participating non-NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$73=1,$AF$73=1,$AG$294=TRUE),$AE$146,0)","v":0},{"$f":"$AF$81","v":false},{"$f":"$AG$81","v":false},{"$f":"$AH$81","v":false},{"$f":"$AI$81","v":false},{"$f":"IF($AE$342=0,FALSE,$AF$342)","v":false},{"$f":"IF($AE$342=0,FALSE,$AG$342)","v":false},{"$f":"IF($AE$342=0,FALSE,$AH$342)","v":false},{"$f":"IF($AE$342=0,FALSE,$AI$342)","v":false},{"$f":"IF(AE342=0,1,IF(AND($AJ$340:$AM$342=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$80=FALSE,AJ342=TRUE)*OR('Amendment Tool'!$M339='Menu Data'!$C$83,'Amendment Tool'!$M339='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$80=FALSE,AK342=TRUE)*OR('Amendment Tool'!$M339='Menu Data'!$C$83,'Amendment Tool'!$M339='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$80=FALSE,AL342=TRUE)*OR('Amendment Tool'!$M339='Menu Data'!$C$83,'Amendment Tool'!$M339='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$80=FALSE,AM342=TRUE)*OR('Amendment Tool'!$M339='Menu Data'!$C$83,'Amendment Tool'!$M339='Menu Data'!$C$84),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Add another change:",null,null,null,null,null,null,null,{"$f":"$AE$296","v":0},false,{"$f":"IF($AE$343=0,FALSE,$AF$343)","v":false}]
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[null,null,"Change 6",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AG$343=TRUE,1,0)","v":0}]
[null,null,"Area of change (select)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$345","v":0},null,{"$f":"IF($M$346=\"\",1,IF(COUNTIF(Area_18,$M$346)=1,1,0))","v":1},null,null,null,null,null,null,{"$f":"IF(AE346=0,1,IF(M346<>\"\",1,0))","v":1}]
[null,null,"Specific change (select - only available when area of change is selected first)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$345","v":0},{"$f":"IF($M$347=\"\",1,(IF($M$346=\"\",1,IF($AE$347=0,1,IF(COUNTIF(INDIRECT($AG$347),$M$347),1,0)))))","v":1},{"$f":"VLOOKUP($M346,Arrays!$A$31:$H$48,8)","v":{"$error":"#N/A"}},null,null,null,null,null,null,{"$f":"IF(AE347=0,1,IF(M347<>\"\",1,0))","v":1}]
[null,null,"Further information (free text - note that this field will adapt to the amount of text entered):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$345","v":0},{"$f":"LEN($M$348)","v":0},{"$f":"COUNTIF(AS348:AS387,1)*90","v":0},{"$f":"AP387-AG348","v":3600},null,null,null,null,null,null,1,{"$f":"AO348*90","v":90},{"$f":"IF(ISNUMBER(FIND(CHAR(10),$M$348,1)),(FIND(CHAR(10),$M$348,1)),0)","v":0},{"$f":"IF(ISNUMBER(FIND(CHAR(13),$M$348,1)),(FIND(CHAR(13),$M$348,1)),0)","v":0},{"$f":"IF(OR(AQ348>0,AR348>0),1,0)","v":0},1,{"$f":"SUM(COUNTIF(AS348:AS387,1),COUNTIF(AT348:AT387,1))","v":1}]
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[null,null,"Applicability:",null,null,null,null,null,null,null,null,null,null,null,null,null,"England",null,null,"Wales",null,null,"Scotland",null,null,"Northern Ireland",null,null,null,null,0]
[null,null,"Where are the participating NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$71=1,$AF$71=1,$AG$343=TRUE),$AE$144,0)","v":0},{"$f":"$AF$77","v":true},{"$f":"$AG$77","v":false},{"$f":"$AH$77","v":false},{"$f":"$AI$77","v":false},{"$f":"IF($AE$389=0,FALSE,$AF$389)","v":false},{"$f":"IF($AE$389=0,FALSE,$AG$389)","v":false},{"$f":"IF($AE$389=0,FALSE,$AH$389)","v":false},{"$f":"IF($AE$389=0,FALSE,$AI$389)","v":false},{"$f":"IF(AE389=0,1,IF(AND($AJ$389:$AM$391=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$76=FALSE,AJ389=TRUE)*OR('Amendment Tool'!$M347='Menu Data'!$C$83,'Amendment Tool'!$M347='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$76=FALSE,AK389=TRUE)*OR('Amendment Tool'!$M347='Menu Data'!$C$83,'Amendment Tool'!$M347='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$76=FALSE,AL389=TRUE)*OR('Amendment Tool'!$M347='Menu Data'!$C$83,'Amendment Tool'!$M347='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$76=FALSE,AM389=TRUE)*OR('Amendment Tool'!$M347='Menu Data'!$C$83,'Amendment Tool'!$M347='Menu Data'!$C$84),1,0)","v":0}]
[null,null,"Will all participating NHS/HSC organisations be affected by this change, or only some? (please note that this answer may affect the categorisation for the change):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$389=0,0,IF(AND($AE$389=1,OR($AJ$389=TRUE,$AK$389=TRUE,$AL$389=TRUE,$AM$389=TRUE)),1,0))","v":0},1]
[null,null,"Where are the participating non-NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$73=1,$AF$73=1,$AG$343=TRUE),$AE$146,0)","v":0},{"$f":"$AF$81","v":false},{"$f":"$AG$81","v":false},{"$f":"$AH$81","v":false},{"$f":"$AI$81","v":false},{"$f":"IF($AE$391=0,FALSE,$AF$391)","v":false},{"$f":"IF($AE$391=0,FALSE,$AG$391)","v":false},{"$f":"IF($AE$391=0,FALSE,$AH$391)","v":false},{"$f":"IF($AE$391=0,FALSE,$AI$391)","v":false},{"$f":"IF(AE391=0,1,IF(AND($AJ$389:$AM$391=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$80=FALSE,AJ391=TRUE)*OR('Amendment Tool'!$M388='Menu Data'!$C$83,'Amendment Tool'!$M388='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$80=FALSE,AK391=TRUE)*OR('Amendment Tool'!$M388='Menu Data'!$C$83,'Amendment Tool'!$M388='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$80=FALSE,AL391=TRUE)*OR('Amendment Tool'!$M388='Menu Data'!$C$83,'Amendment Tool'!$M388='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$80=FALSE,AM391=TRUE)*OR('Amendment Tool'!$M388='Menu Data'!$C$83,'Amendment Tool'!$M388='Menu Data'!$C$84),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Add another change:",null,null,null,null,null,null,null,{"$f":"$AE$345","v":0},false,{"$f":"IF($AE$392=0,FALSE,$AF$392)","v":false}]
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[null,null,"Change 7",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AG$392=TRUE,1,0)","v":0}]
[null,null,"Area of change (select)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$394","v":0},null,{"$f":"IF($M$395=\"\",1,IF(COUNTIF(Area_18,$M$395)=1,1,0))","v":1},null,null,null,null,null,null,{"$f":"IF(AE395=0,1,IF(M395<>\"\",1,0))","v":1}]
[null,null,"Specific change (select - only available when area of change is selected first)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$394","v":0},{"$f":"IF($M$396=\"\",1,(IF($M$395=\"\",1,IF($AE$396=0,1,IF(COUNTIF(INDIRECT($AG$396),$M$396),1,0)))))","v":1},{"$f":"VLOOKUP($M395,Arrays!$A$31:$H$48,8)","v":{"$error":"#N/A"}},null,null,null,null,null,null,{"$f":"IF(AE396=0,1,IF(M396<>\"\",1,0))","v":1}]
[null,null,"Further information (free text - note that this field will adapt to the amount of text entered):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$394","v":0},{"$f":"LEN($M$397)","v":0},{"$f":"COUNTIF(AS397:AS436,1)*90","v":0},{"$f":"AP436-AG397","v":3600},null,null,null,null,null,null,1,{"$f":"AO397*90","v":90},{"$f":"IF(ISNUMBER(FIND(CHAR(10),$M$397,1)),(FIND(CHAR(10),$M$397,1)),0)","v":0},{"$f":"IF(ISNUMBER(FIND(CHAR(13),$M$397,1)),(FIND(CHAR(13),$M$397,1)),0)","v":0},{"$f":"IF(OR(AQ397>0,AR397>0),1,0)","v":0},1,{"$f":"SUM(COUNTIF(AS397:AS436,1),COUNTIF(AT397:AT436,1))","v":1}]
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[null,null,"Applicability:",null,null,null,null,null,null,null,null,null,null,null,null,null,"England",null,null,"Wales",null,null,"Scotland",null,null,"Northern Ireland",null,null,null,null,0]
[null,null,"Where are the participating NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$71=1,$AF$71=1,$AG$392=TRUE),$AE$144,0)","v":0},{"$f":"$AF$77","v":true},{"$f":"$AG$77","v":false},{"$f":"$AH$77","v":false},{"$f":"$AI$77","v":false},{"$f":"IF($AE$438=0,FALSE,$AF$438)","v":false},{"$f":"IF($AE$438=0,FALSE,$AG$438)","v":false},{"$f":"IF($AE$438=0,FALSE,$AH$438)","v":false},{"$f":"IF($AE$438=0,FALSE,$AI$438)","v":false},{"$f":"IF(AE438=0,1,IF(AND($AJ$438:$AM$440=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$76=FALSE,AJ438=TRUE)*OR('Amendment Tool'!$M396='Menu Data'!$C$83,'Amendment Tool'!$M396='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$76=FALSE,AK438=TRUE)*OR('Amendment Tool'!$M396='Menu Data'!$C$83,'Amendment Tool'!$M396='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$76=FALSE,AL438=TRUE)*OR('Amendment Tool'!$M396='Menu Data'!$C$83,'Amendment Tool'!$M396='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$76=FALSE,AM438=TRUE)*OR('Amendment Tool'!$M396='Menu Data'!$C$83,'Amendment Tool'!$M396='Menu Data'!$C$84),1,0)","v":0}]
[null,null,"Will all participating NHS/HSC organisations be affected by this change, or only some? (please note that this answer may affect the categorisation for the change):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$438=0,0,IF(AND($AE$438=1,OR($AJ$438=TRUE,$AK$438=TRUE,$AL$438=TRUE,$AM$438=TRUE)),1,0))","v":0},1]
[null,null,"Where are the participating non-NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$73=1,$AF$73=1,$AG$392=TRUE),$AE$146,0)","v":0},{"$f":"$AF$81","v":false},{"$f":"$AG$81","v":false},{"$f":"$AH$81","v":false},{"$f":"$AI$81","v":false},{"$f":"IF($AE$440=0,FALSE,$AF$440)","v":false},{"$f":"IF($AE$440=0,FALSE,$AG$440)","v":false},{"$f":"IF($AE$440=0,FALSE,$AH$440)","v":false},{"$f":"IF($AE$440=0,FALSE,$AI$440)","v":false},{"$f":"IF(AE440=0,1,IF(AND($AJ$438:$AM$440=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$80=FALSE,AJ440=TRUE)*OR('Amendment Tool'!$M437='Menu Data'!$C$83,'Amendment Tool'!$M437='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$80=FALSE,AK440=TRUE)*OR('Amendment Tool'!$M437='Menu Data'!$C$83,'Amendment Tool'!$M437='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$80=FALSE,AL440=TRUE)*OR('Amendment Tool'!$M437='Menu Data'!$C$83,'Amendment Tool'!$M437='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$80=FALSE,AM440=TRUE)*OR('Amendment Tool'!$M437='Menu Data'!$C$83,'Amendment Tool'!$M437='Menu Data'!$C$84),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Add another change:",null,null,null,null,null,null,null,{"$f":"$AE$394","v":0},false,{"$f":"IF($AE$441=0,FALSE,$AF$441)","v":false}]
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[null,null,"Change 8",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AG$441=TRUE,1,0)","v":0}]
[null,null,"Area of change (select)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$443","v":0},null,{"$f":"IF($M$444=\"\",1,IF(COUNTIF(Area_18,$M$444)=1,1,0))","v":1},null,null,null,null,null,null,{"$f":"IF(AE444=0,1,IF(M444<>\"\",1,0))","v":1}]
[null,null,"Specific change (select - only available when area of change is selected first)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$443","v":0},{"$f":"IF($M$445=\"\",1,(IF($M$444=\"\",1,IF($AE$445=0,1,IF(COUNTIF(INDIRECT($AG$445),$M$445),1,0)))))","v":1},{"$f":"VLOOKUP($M444,Arrays!$A$31:$H$48,8)","v":{"$error":"#N/A"}},null,null,null,null,null,null,{"$f":"IF(AE445=0,1,IF(M445<>\"\",1,0))","v":1}]
[null,null,"Further information (free text - note that this field will adapt to the amount of text entered):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$443","v":0},{"$f":"LEN($M$446)","v":0},{"$f":"COUNTIF(AS446:AS485,1)*90","v":0},{"$f":"AP485-AG446","v":3600},null,null,null,null,null,null,1,{"$f":"AO446*90","v":90},{"$f":"IF(ISNUMBER(FIND(CHAR(10),$M$446,1)),(FIND(CHAR(10),$M$446,1)),0)","v":0},{"$f":"IF(ISNUMBER(FIND(CHAR(13),$M$446,1)),(FIND(CHAR(13),$M$446,1)),0)","v":0},{"$f":"IF(OR(AQ446>0,AR446>0),1,0)","v":0},1,{"$f":"SUM(COUNTIF(AS446:AS485,1),COUNTIF(AT446:AT485,1))","v":1}]
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[null,null,"Applicability:",null,null,null,null,null,null,null,null,null,null,null,null,null,"England",null,null,"Wales",null,null,"Scotland",null,null,"Northern Ireland",null,null,null,null,0]
[null,null,"Where are the participating NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$71=1,$AF$71=1,$AG$441=TRUE),$AE$144,0)","v":0},{"$f":"$AF$77","v":true},{"$f":"$AG$77","v":false},{"$f":"$AH$77","v":false},{"$f":"$AI$77","v":false},{"$f":"IF($AE$487=0,FALSE,$AF$487)","v":false},{"$f":"IF($AE$487=0,FALSE,$AG$487)","v":false},{"$f":"IF($AE$487=0,FALSE,$AH$487)","v":false},{"$f":"IF($AE$487=0,FALSE,$AI$487)","v":false},{"$f":"IF(AE487=0,1,IF(AND($AJ$487:$AM$489=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$76=FALSE,AJ487=TRUE)*OR('Amendment Tool'!$M445='Menu Data'!$C$83,'Amendment Tool'!$M445='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$76=FALSE,AK487=TRUE)*OR('Amendment Tool'!$M445='Menu Data'!$C$83,'Amendment Tool'!$M445='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$76=FALSE,AL487=TRUE)*OR('Amendment Tool'!$M445='Menu Data'!$C$83,'Amendment Tool'!$M445='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$76=FALSE,AM487=TRUE)*OR('Amendment Tool'!$M445='Menu Data'!$C$83,'Amendment Tool'!$M445='Menu Data'!$C$84),1,0)","v":0}]
[null,null,"Will all participating NHS/HSC organisations be affected by this change, or only some? (please note that this answer may affect the categorisation for the change):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$487=0,0,IF(AND($AE$487=1,OR($AJ$487=TRUE,$AK$487=TRUE,$AL$487=TRUE,$AM$487=TRUE)),1,0))","v":0},1]
[null,null,"Where are the participating non-NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$73=1,$AF$73=1,$AG$441=TRUE),$AE$146,0)","v":0},{"$f":"$AF$81","v":false},{"$f":"$AG$81","v":false},{"$f":"$AH$81","v":false},{"$f":"$AI$81","v":false},{"$f":"IF($AE$489=0,FALSE,$AF$489)","v":false},{"$f":"IF($AE$489=0,FALSE,$AG$489)","v":false},{"$f":"IF($AE$489=0,FALSE,$AH$489)","v":false},{"$f":"IF($AE$489=0,FALSE,$AI$489)","v":false},{"$f":"IF(AE489=0,1,IF(AND($AJ$487:$AM$489=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$80=FALSE,AJ489=TRUE)*OR('Amendment Tool'!$M486='Menu Data'!$C$83,'Amendment Tool'!$M486='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$80=FALSE,AK489=TRUE)*OR('Amendment Tool'!$M486='Menu Data'!$C$83,'Amendment Tool'!$M486='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$80=FALSE,AL489=TRUE)*OR('Amendment Tool'!$M486='Menu Data'!$C$83,'Amendment Tool'!$M486='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$80=FALSE,AM489=TRUE)*OR('Amendment Tool'!$M486='Menu Data'!$C$83,'Amendment Tool'!$M486='Menu Data'!$C$84),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Add another change:",null,null,null,null,null,null,null,{"$f":"$AE$443","v":0},false,{"$f":"IF($AE$490=0,FALSE,$AF$490)","v":false}]
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[null,null,"Change 9",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AG$490=TRUE,1,0)","v":0}]
[null,null,"Area of change (select)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$492","v":0},null,{"$f":"IF($M$493=\"\",1,IF(COUNTIF(Area_18,$M$493)=1,1,0))","v":1},null,null,null,null,null,null,{"$f":"IF(AE493=0,1,IF(M493<>\"\",1,0))","v":1}]
[null,null,"Specific change (select - only available when area of change is selected first)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$492","v":0},{"$f":"IF($M$494=\"\",1,(IF($M$493=\"\",1,IF($AE$494=0,1,IF(COUNTIF(INDIRECT($AG$494),$M$494),1,0)))))","v":1},{"$f":"VLOOKUP($M493,Arrays!$A$31:$H$48,8)","v":{"$error":"#N/A"}},null,null,null,null,null,null,{"$f":"IF(AE494=0,1,IF(M494<>\"\",1,0))","v":1}]
[null,null,"Further information (free text - note that this field will adapt to the amount of text entered):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$492","v":0},{"$f":"LEN($M$495)","v":0},{"$f":"COUNTIF(AS495:AS534,1)*90","v":0},{"$f":"AP534-AG495","v":3600},null,null,null,null,null,null,1,{"$f":"AO495*90","v":90},{"$f":"IF(ISNUMBER(FIND(CHAR(10),$M$495,1)),(FIND(CHAR(10),$M$495,1)),0)","v":0},{"$f":"IF(ISNUMBER(FIND(CHAR(13),$M$495,1)),(FIND(CHAR(13),$M$495,1)),0)","v":0},{"$f":"IF(OR(AQ495>0,AR495>0),1,0)","v":0},1,{"$f":"SUM(COUNTIF(AS495:AS534,1),COUNTIF(AT495:AT534,1))","v":1}]
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[null,null,"Applicability:",null,null,null,null,null,null,null,null,null,null,null,null,null,"England",null,null,"Wales",null,null,"Scotland",null,null,"Northern Ireland",null,null,null,null,0]
[null,null,"Where are the participating NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$71=1,$AF$71=1,$AG$490=TRUE),$AE$144,0)","v":0},{"$f":"$AF$77","v":true},{"$f":"$AG$77","v":false},{"$f":"$AH$77","v":false},{"$f":"$AI$77","v":false},{"$f":"IF($AE$536=0,FALSE,$AF$536)","v":false},{"$f":"IF($AE$536=0,FALSE,$AG$536)","v":false},{"$f":"IF($AE$536=0,FALSE,$AH$536)","v":false},{"$f":"IF($AE$536=0,FALSE,$AI$536)","v":false},{"$f":"IF(AE536=0,1,IF(AND($AJ$536:$AM$538=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$76=FALSE,AJ536=TRUE)*OR('Amendment Tool'!$M494='Menu Data'!$C$83,'Amendment Tool'!$M494='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$76=FALSE,AK536=TRUE)*OR('Amendment Tool'!$M494='Menu Data'!$C$83,'Amendment Tool'!$M494='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$76=FALSE,AL536=TRUE)*OR('Amendment Tool'!$M494='Menu Data'!$C$83,'Amendment Tool'!$M494='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$76=FALSE,AM536=TRUE)*OR('Amendment Tool'!$M494='Menu Data'!$C$83,'Amendment Tool'!$M494='Menu Data'!$C$84),1,0)","v":0}]
[null,null,"Will all participating NHS/HSC organisations be affected by this change, or only some? (please note that this answer may affect the categorisation for the change):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$536=0,0,IF(AND($AE$536=1,OR($AJ$536=TRUE,$AK$536=TRUE,$AL$536=TRUE,$AM$536=TRUE)),1,0))","v":0},1]
[null,null,"Where are the participating non-NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$73=1,$AF$73=1,$AG$490=TRUE),$AE$146,0)","v":0},{"$f":"$AF$81","v":false},{"$f":"$AG$81","v":false},{"$f":"$AH$81","v":false},{"$f":"$AI$81","v":false},{"$f":"IF($AE$538=0,FALSE,$AF$538)","v":false},{"$f":"IF($AE$538=0,FALSE,$AG$538)","v":false},{"$f":"IF($AE$538=0,FALSE,$AH$538)","v":false},{"$f":"IF($AE$538=0,FALSE,$AI$538)","v":false},{"$f":"IF(AE538=0,1,IF(AND($AJ$536:$AM$538=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$80=FALSE,AJ538=TRUE)*OR('Amendment Tool'!$M535='Menu Data'!$C$83,'Amendment Tool'!$M535='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$80=FALSE,AK538=TRUE)*OR('Amendment Tool'!$M535='Menu Data'!$C$83,'Amendment Tool'!$M535='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$80=FALSE,AL538=TRUE)*OR('Amendment Tool'!$M535='Menu Data'!$C$83,'Amendment Tool'!$M535='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$80=FALSE,AM538=TRUE)*OR('Amendment Tool'!$M535='Menu Data'!$C$83,'Amendment Tool'!$M535='Menu Data'!$C$84),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Add another change:",null,null,null,null,null,null,null,{"$f":"$AE$492","v":0},false,{"$f":"IF($AE$539=0,FALSE,$AF$539)","v":false}]
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[null,null,"Change 10",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AG$539=TRUE,1,0)","v":0}]
[null,null,"Area of change (select)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$541","v":0},null,{"$f":"IF($M$542=\"\",1,IF(COUNTIF(Area_18,$M$542)=1,1,0))","v":1},null,null,null,null,null,null,{"$f":"IF(AE542=0,1,IF(M542<>\"\",1,0))","v":1}]
[null,null,"Specific change (select - only available when area of change is selected first)*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$541","v":0},{"$f":"IF($M$543=\"\",1,(IF($M$542=\"\",1,IF($AE$543=0,1,IF(COUNTIF(INDIRECT($AG$543),$M$543),1,0)))))","v":1},{"$f":"VLOOKUP($M542,Arrays!$A$31:$H$48,8)","v":{"$error":"#N/A"}},null,null,null,null,null,null,{"$f":"IF(AE543=0,1,IF(M543<>\"\",1,0))","v":1}]
[null,null,"Further information (free text - note that this field will adapt to the amount of text entered):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$541","v":0},{"$f":"LEN($M$544)","v":0},{"$f":"COUNTIF(AS544:AS583,1)*90","v":0},{"$f":"AP583-AG544","v":3600},null,null,null,null,null,null,1,{"$f":"AO544*90","v":90},{"$f":"IF(ISNUMBER(FIND(CHAR(10),$M$544,1)),(FIND(CHAR(10),$M$544,1)),0)","v":0},{"$f":"IF(ISNUMBER(FIND(CHAR(13),$M$544,1)),(FIND(CHAR(13),$M$544,1)),0)","v":0},{"$f":"IF(OR(AQ544>0,AR544>0),1,0)","v":0},1,{"$f":"SUM(COUNTIF(AS544:AS583,1),COUNTIF(AT544:AT583,1))","v":1}]
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[null,null,"Applicability:",null,null,null,null,null,null,null,null,null,null,null,null,null,"England",null,null,"Wales",null,null,"Scotland",null,null,"Northern Ireland",null,null,null,null,0]
[null,null,"Where are the participating NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$71=1,$AF$71=1,$AG$539=TRUE),$AE$144,0)","v":0},{"$f":"$AF$77","v":true},{"$f":"$AG$77","v":false},{"$f":"$AH$77","v":false},{"$f":"$AI$77","v":false},{"$f":"IF($AE$585=0,FALSE,$AF$585)","v":false},{"$f":"IF($AE$585=0,FALSE,$AG$585)","v":false},{"$f":"IF($AE$585=0,FALSE,$AH$585)","v":false},{"$f":"IF($AE$585=0,FALSE,$AI$585)","v":false},{"$f":"IF(AE585=0,1,IF(AND($AJ$585:$AM$587=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$76=FALSE,AJ585=TRUE)*OR('Amendment Tool'!$M543='Menu Data'!$C$83,'Amendment Tool'!$M543='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$76=FALSE,AK585=TRUE)*OR('Amendment Tool'!$M543='Menu Data'!$C$83,'Amendment Tool'!$M543='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$76=FALSE,AL585=TRUE)*OR('Amendment Tool'!$M543='Menu Data'!$C$83,'Amendment Tool'!$M543='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$76=FALSE,AM585=TRUE)*OR('Amendment Tool'!$M543='Menu Data'!$C$83,'Amendment Tool'!$M543='Menu Data'!$C$84),1,0)","v":0}]
[null,null,"Will all participating NHS/HSC organisations be affected by this change, or only some? (please note that this answer may affect the categorisation for the change):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$585=0,0,IF(AND($AE$585=1,OR($AJ$585=TRUE,$AK$585=TRUE,$AL$585=TRUE,$AM$585=TRUE)),1,0))","v":0},1]
[null,null,"Where are the participating non-NHS/HSC organisations located that will be affected by this change?*:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$73=1,$AF$73=1,$AG$539=TRUE),$AE$146,0)","v":0},{"$f":"$AF$81","v":false},{"$f":"$AG$81","v":false},{"$f":"$AH$81","v":false},{"$f":"$AI$81","v":false},{"$f":"IF($AE$587=0,FALSE,$AF$587)","v":false},{"$f":"IF($AE$587=0,FALSE,$AG$587)","v":false},{"$f":"IF($AE$587=0,FALSE,$AH$587)","v":false},{"$f":"IF($AE$587=0,FALSE,$AI$587)","v":false},{"$f":"IF(AE587=0,1,IF(AND($AJ$585:$AM$587=FALSE),0,1))","v":1},{"$f":"IF(AND($AF$80=FALSE,AJ587=TRUE)*OR('Amendment Tool'!$M584='Menu Data'!$C$83,'Amendment Tool'!$M584='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AG$80=FALSE,AK587=TRUE)*OR('Amendment Tool'!$M584='Menu Data'!$C$83,'Amendment Tool'!$M584='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AH$80=FALSE,AL587=TRUE)*OR('Amendment Tool'!$M584='Menu Data'!$C$83,'Amendment Tool'!$M584='Menu Data'!$C$84),1,0)","v":0},{"$f":"IF(AND($AI$80=FALSE,AM587=TRUE)*OR('Amendment Tool'!$M584='Menu Data'!$C$83,'Amendment Tool'!$M584='Menu Data'!$C$84),1,0)","v":0}]
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[null,"Section 3: Declaration(s) and lock for submission",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,"Declaration by the Sponsor or authorised delegate",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null," •  I confirm that the Sponsor takes responsibility for the completed amendment tool\n •  I confirm that I have been formally authorised by the Sponsor to complete the amendment tool on their behalf",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,"Name [first name and surname]*:",null,null,null,null,null,null,null,"Dr Birgit Whitman",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1,null,null,null,null,null,null,null,null,{"$f":"IF(K593<>\"\",1,0)","v":1}]
[null,null,"Email address*:",null,null,null,null,null,null,null,"researchgovernance@contacts.bham.ac.uk",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1,null,null,null,null,null,null,null,null,{"$f":"IF(K594<>\"\",1,0)","v":1}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,"Lock for submission",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,"Please note: This button will only become available when all mandatory (*) fields have been completed. When the button is available, clicking it\nwill generate a locked PDF copy of the completed amendment tool which must be included in the amendment submission. Please ensure that the amendment tool is completed correctly before locking it for submission.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,null,null,"Lock for submission",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1,null,null,null,null,null,null,null,null,{"$f":"IF(COUNTIF(AN6:AN594,0),0,1)","v":1}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,"After locking the tool, proceed to submit the amendment online. The \"Submission Guidance\" tab provides further information about the next steps for the amendment.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,"Section 4: Review bodies for the amendment",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,"Please note: This section is for information only. Details in this section will complete automatically based on the options selected in Sections 1 and 2.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,"Review bodies",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,"UK wide:",null,null,null,null,null,"England and Wales:",null,null,null,"Scotland:",null,null,null,"Northern Ireland:",null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,{"$f":"IF($AF$55=1,\"REC\",\"MoDREC\")","v":"REC"},"Competent Authority\nMHRA - Medicines","Competent Authority\nMHRA - Devices","ARSAC","Radiation Assurance","UKSW Governance","REC (MCA)","CAG","HMPPS","HRA and HCRW Approval","REC (AWIA)","PBPP","SPS (RAEC)",{"$f":"IF(AND($AE$78=1,$AF$78=1),\"NHS organisation\",\"National coordinating function\")","v":"National coordinating function"},"HSC REC","HSC Data Guardians","Prisons",{"$f":"IF(AND($AE$79=1,$AF$79=1),\"NHS organisation\",\"National coordinating function\")","v":"National coordinating function"},null,null,null,null,1]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Category:",null,null,null,1,null,null,null,null,null,null,null,null,"Type:","Annex 2 type:","Annex 2 reason:","CWoW:"]
[null,null,"Change 1:",null,null,null,null,null,{"$f":"IF(AND(Arrays!$K$8='Menu Data'!$A$32,Arrays!$K$18='Menu Data'!$A$32,Arrays!$K$28='Menu Data'!$A$32,Arrays!$K$38='Menu Data'!$A$32,Arrays!$K$48='Menu Data'!$A$32,Arrays!$K$58='Menu Data'!$A$32,Arrays!$K$68='Menu Data'!$A$32,Arrays!$K$78='Menu Data'!$A$32,Arrays!$K$88='Menu Data'!$A$32,Arrays!$K$98='Menu Data'!$A$32),\"\",Arrays!$K$8)","v":"N"},{"$f":"IF(AND(Arrays!$L$8='Menu Data'!$A$32,Arrays!$L$18='Menu Data'!$A$32,Arrays!$L$28='Menu Data'!$A$32,Arrays!$L$38='Menu Data'!$A$32,Arrays!$L$48='Menu Data'!$A$32,Arrays!$L$58='Menu Data'!$A$32,Arrays!$L$68='Menu Data'!$A$32,Arrays!$L$78='Menu Data'!$A$32,Arrays!$L$88='Menu Data'!$A$32,Arrays!$L$98='Menu Data'!$A$32),\"\",Arrays!$L$8)","v":""},{"$f":"IF(AND(Arrays!$M$8='Menu Data'!$A$32,Arrays!$M$18='Menu Data'!$A$32,Arrays!$M$28='Menu Data'!$A$32,Arrays!$M$38='Menu Data'!$A$32,Arrays!$M$48='Menu Data'!$A$32,Arrays!$M$58='Menu Data'!$A$32,Arrays!$M$68='Menu Data'!$A$32,Arrays!$M$78='Menu 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[null,null,"Change 2:",null,null,null,null,null,{"$f":"IF(AND(Arrays!$K$8='Menu Data'!$A$32,Arrays!$K$18='Menu Data'!$A$32,Arrays!$K$28='Menu Data'!$A$32,Arrays!$K$38='Menu Data'!$A$32,Arrays!$K$48='Menu Data'!$A$32,Arrays!$K$58='Menu Data'!$A$32,Arrays!$K$68='Menu Data'!$A$32,Arrays!$K$78='Menu Data'!$A$32,Arrays!$K$88='Menu Data'!$A$32,Arrays!$K$98='Menu Data'!$A$32),\"\",Arrays!$K$18)","v":"Y"},{"$f":"IF(AND(Arrays!$L$8='Menu Data'!$A$32,Arrays!$L$18='Menu Data'!$A$32,Arrays!$L$28='Menu Data'!$A$32,Arrays!$L$38='Menu Data'!$A$32,Arrays!$L$48='Menu Data'!$A$32,Arrays!$L$58='Menu Data'!$A$32,Arrays!$L$68='Menu Data'!$A$32,Arrays!$L$78='Menu Data'!$A$32,Arrays!$L$88='Menu Data'!$A$32,Arrays!$L$98='Menu Data'!$A$32),\"\",Arrays!$L$18)","v":""},{"$f":"IF(AND(Arrays!$M$8='Menu Data'!$A$32,Arrays!$M$18='Menu Data'!$A$32,Arrays!$M$28='Menu Data'!$A$32,Arrays!$M$38='Menu Data'!$A$32,Arrays!$M$48='Menu Data'!$A$32,Arrays!$M$58='Menu Data'!$A$32,Arrays!$M$68='Menu 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[null,null,"Change 3:",null,null,null,null,null,{"$f":"IF(AND(Arrays!$K$8='Menu Data'!$A$32,Arrays!$K$18='Menu Data'!$A$32,Arrays!$K$28='Menu Data'!$A$32,Arrays!$K$38='Menu Data'!$A$32,Arrays!$K$48='Menu Data'!$A$32,Arrays!$K$58='Menu Data'!$A$32,Arrays!$K$68='Menu Data'!$A$32,Arrays!$K$78='Menu Data'!$A$32,Arrays!$K$88='Menu Data'!$A$32,Arrays!$K$98='Menu Data'!$A$32),\"\",Arrays!$K$28)","v":"N"},{"$f":"IF(AND(Arrays!$L$8='Menu Data'!$A$32,Arrays!$L$18='Menu Data'!$A$32,Arrays!$L$28='Menu Data'!$A$32,Arrays!$L$38='Menu Data'!$A$32,Arrays!$L$48='Menu Data'!$A$32,Arrays!$L$58='Menu Data'!$A$32,Arrays!$L$68='Menu Data'!$A$32,Arrays!$L$78='Menu Data'!$A$32,Arrays!$L$88='Menu Data'!$A$32,Arrays!$L$98='Menu Data'!$A$32),\"\",Arrays!$L$28)","v":""},{"$f":"IF(AND(Arrays!$M$8='Menu Data'!$A$32,Arrays!$M$18='Menu Data'!$A$32,Arrays!$M$28='Menu Data'!$A$32,Arrays!$M$38='Menu Data'!$A$32,Arrays!$M$48='Menu Data'!$A$32,Arrays!$M$58='Menu Data'!$A$32,Arrays!$M$68='Menu 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[null,null,"Change 5:",null,null,null,null,null,{"$f":"IF(AND(Arrays!$K$8='Menu Data'!$A$32,Arrays!$K$18='Menu Data'!$A$32,Arrays!$K$28='Menu Data'!$A$32,Arrays!$K$38='Menu Data'!$A$32,Arrays!$K$48='Menu Data'!$A$32,Arrays!$K$58='Menu Data'!$A$32,Arrays!$K$68='Menu Data'!$A$32,Arrays!$K$78='Menu Data'!$A$32,Arrays!$K$88='Menu Data'!$A$32,Arrays!$K$98='Menu Data'!$A$32),\"\",Arrays!$K$48)","v":"N"},{"$f":"IF(AND(Arrays!$L$8='Menu Data'!$A$32,Arrays!$L$18='Menu Data'!$A$32,Arrays!$L$28='Menu Data'!$A$32,Arrays!$L$38='Menu Data'!$A$32,Arrays!$L$48='Menu Data'!$A$32,Arrays!$L$58='Menu Data'!$A$32,Arrays!$L$68='Menu Data'!$A$32,Arrays!$L$78='Menu Data'!$A$32,Arrays!$L$88='Menu Data'!$A$32,Arrays!$L$98='Menu Data'!$A$32),\"\",Arrays!$L$48)","v":""},{"$f":"IF(AND(Arrays!$M$8='Menu Data'!$A$32,Arrays!$M$18='Menu Data'!$A$32,Arrays!$M$28='Menu Data'!$A$32,Arrays!$M$38='Menu Data'!$A$32,Arrays!$M$48='Menu Data'!$A$32,Arrays!$M$58='Menu Data'!$A$32,Arrays!$M$68='Menu 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[null,null,"Change 6:",null,null,null,null,null,{"$f":"IF(AND(Arrays!$K$8='Menu Data'!$A$32,Arrays!$K$18='Menu Data'!$A$32,Arrays!$K$28='Menu Data'!$A$32,Arrays!$K$38='Menu Data'!$A$32,Arrays!$K$48='Menu Data'!$A$32,Arrays!$K$58='Menu Data'!$A$32,Arrays!$K$68='Menu Data'!$A$32,Arrays!$K$78='Menu Data'!$A$32,Arrays!$K$88='Menu Data'!$A$32,Arrays!$K$98='Menu Data'!$A$32),\"\",Arrays!$K$58)","v":"N"},{"$f":"IF(AND(Arrays!$L$8='Menu Data'!$A$32,Arrays!$L$18='Menu Data'!$A$32,Arrays!$L$28='Menu Data'!$A$32,Arrays!$L$38='Menu Data'!$A$32,Arrays!$L$48='Menu Data'!$A$32,Arrays!$L$58='Menu Data'!$A$32,Arrays!$L$68='Menu Data'!$A$32,Arrays!$L$78='Menu Data'!$A$32,Arrays!$L$88='Menu Data'!$A$32,Arrays!$L$98='Menu Data'!$A$32),\"\",Arrays!$L$58)","v":""},{"$f":"IF(AND(Arrays!$M$8='Menu Data'!$A$32,Arrays!$M$18='Menu Data'!$A$32,Arrays!$M$28='Menu Data'!$A$32,Arrays!$M$38='Menu Data'!$A$32,Arrays!$M$48='Menu Data'!$A$32,Arrays!$M$58='Menu Data'!$A$32,Arrays!$M$68='Menu 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[null,null,"Change 7:",null,null,null,null,null,{"$f":"IF(AND(Arrays!$K$8='Menu Data'!$A$32,Arrays!$K$18='Menu Data'!$A$32,Arrays!$K$28='Menu Data'!$A$32,Arrays!$K$38='Menu Data'!$A$32,Arrays!$K$48='Menu Data'!$A$32,Arrays!$K$58='Menu Data'!$A$32,Arrays!$K$68='Menu Data'!$A$32,Arrays!$K$78='Menu Data'!$A$32,Arrays!$K$88='Menu Data'!$A$32,Arrays!$K$98='Menu Data'!$A$32),\"\",Arrays!$K$68)","v":"N"},{"$f":"IF(AND(Arrays!$L$8='Menu Data'!$A$32,Arrays!$L$18='Menu Data'!$A$32,Arrays!$L$28='Menu Data'!$A$32,Arrays!$L$38='Menu Data'!$A$32,Arrays!$L$48='Menu Data'!$A$32,Arrays!$L$58='Menu Data'!$A$32,Arrays!$L$68='Menu Data'!$A$32,Arrays!$L$78='Menu Data'!$A$32,Arrays!$L$88='Menu Data'!$A$32,Arrays!$L$98='Menu Data'!$A$32),\"\",Arrays!$L$68)","v":""},{"$f":"IF(AND(Arrays!$M$8='Menu Data'!$A$32,Arrays!$M$18='Menu Data'!$A$32,Arrays!$M$28='Menu Data'!$A$32,Arrays!$M$38='Menu Data'!$A$32,Arrays!$M$48='Menu Data'!$A$32,Arrays!$M$58='Menu Data'!$A$32,Arrays!$M$68='Menu 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[null,null,"Change 8:",null,null,null,null,null,{"$f":"IF(AND(Arrays!$K$8='Menu Data'!$A$32,Arrays!$K$18='Menu Data'!$A$32,Arrays!$K$28='Menu Data'!$A$32,Arrays!$K$38='Menu Data'!$A$32,Arrays!$K$48='Menu Data'!$A$32,Arrays!$K$58='Menu Data'!$A$32,Arrays!$K$68='Menu Data'!$A$32,Arrays!$K$78='Menu Data'!$A$32,Arrays!$K$88='Menu Data'!$A$32,Arrays!$K$98='Menu Data'!$A$32),\"\",Arrays!$K$78)","v":"N"},{"$f":"IF(AND(Arrays!$L$8='Menu Data'!$A$32,Arrays!$L$18='Menu Data'!$A$32,Arrays!$L$28='Menu Data'!$A$32,Arrays!$L$38='Menu Data'!$A$32,Arrays!$L$48='Menu Data'!$A$32,Arrays!$L$58='Menu Data'!$A$32,Arrays!$L$68='Menu Data'!$A$32,Arrays!$L$78='Menu Data'!$A$32,Arrays!$L$88='Menu Data'!$A$32,Arrays!$L$98='Menu Data'!$A$32),\"\",Arrays!$L$78)","v":""},{"$f":"IF(AND(Arrays!$M$8='Menu Data'!$A$32,Arrays!$M$18='Menu Data'!$A$32,Arrays!$M$28='Menu Data'!$A$32,Arrays!$M$38='Menu Data'!$A$32,Arrays!$M$48='Menu Data'!$A$32,Arrays!$M$58='Menu Data'!$A$32,Arrays!$M$68='Menu 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[null,null,"Change 9:",null,null,null,null,null,{"$f":"IF(AND(Arrays!$K$8='Menu Data'!$A$32,Arrays!$K$18='Menu Data'!$A$32,Arrays!$K$28='Menu Data'!$A$32,Arrays!$K$38='Menu Data'!$A$32,Arrays!$K$48='Menu Data'!$A$32,Arrays!$K$58='Menu Data'!$A$32,Arrays!$K$68='Menu Data'!$A$32,Arrays!$K$78='Menu Data'!$A$32,Arrays!$K$88='Menu Data'!$A$32,Arrays!$K$98='Menu Data'!$A$32),\"\",Arrays!$K$88)","v":"N"},{"$f":"IF(AND(Arrays!$L$8='Menu Data'!$A$32,Arrays!$L$18='Menu Data'!$A$32,Arrays!$L$28='Menu Data'!$A$32,Arrays!$L$38='Menu Data'!$A$32,Arrays!$L$48='Menu Data'!$A$32,Arrays!$L$58='Menu Data'!$A$32,Arrays!$L$68='Menu Data'!$A$32,Arrays!$L$78='Menu Data'!$A$32,Arrays!$L$88='Menu Data'!$A$32,Arrays!$L$98='Menu Data'!$A$32),\"\",Arrays!$L$88)","v":""},{"$f":"IF(AND(Arrays!$M$8='Menu Data'!$A$32,Arrays!$M$18='Menu Data'!$A$32,Arrays!$M$28='Menu Data'!$A$32,Arrays!$M$38='Menu Data'!$A$32,Arrays!$M$48='Menu Data'!$A$32,Arrays!$M$58='Menu Data'!$A$32,Arrays!$M$68='Menu 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[null,null,"Change 10:",null,null,null,null,null,{"$f":"IF(AND(Arrays!$K$8='Menu Data'!$A$32,Arrays!$K$18='Menu Data'!$A$32,Arrays!$K$28='Menu Data'!$A$32,Arrays!$K$38='Menu Data'!$A$32,Arrays!$K$48='Menu Data'!$A$32,Arrays!$K$58='Menu Data'!$A$32,Arrays!$K$68='Menu Data'!$A$32,Arrays!$K$78='Menu Data'!$A$32,Arrays!$K$88='Menu Data'!$A$32,Arrays!$K$98='Menu Data'!$A$32),\"\",Arrays!$K$98)","v":"N"},{"$f":"IF(AND(Arrays!$L$8='Menu Data'!$A$32,Arrays!$L$18='Menu Data'!$A$32,Arrays!$L$28='Menu Data'!$A$32,Arrays!$L$38='Menu Data'!$A$32,Arrays!$L$48='Menu Data'!$A$32,Arrays!$L$58='Menu Data'!$A$32,Arrays!$L$68='Menu Data'!$A$32,Arrays!$L$78='Menu Data'!$A$32,Arrays!$L$88='Menu Data'!$A$32,Arrays!$L$98='Menu Data'!$A$32),\"\",Arrays!$L$98)","v":""},{"$f":"IF(AND(Arrays!$M$8='Menu Data'!$A$32,Arrays!$M$18='Menu Data'!$A$32,Arrays!$M$28='Menu Data'!$A$32,Arrays!$M$38='Menu Data'!$A$32,Arrays!$M$48='Menu Data'!$A$32,Arrays!$M$58='Menu Data'!$A$32,Arrays!$M$68='Menu 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[null,null,"Overall reviews for the amendment:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$90","v":1},null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AQ$613:$AQ$622=\"\",\"\",IF(OR($AQ$613:$AQ$622='Menu Data'!$A$86),\"Yes\",\"No\"))","v":""}]
[null,null,"Full review:",null,null,null,null,null,{"$f":"Arrays!G2","v":"Y"},{"$f":"Arrays!G3","v":""},{"$f":"Arrays!G4","v":""},{"$f":"Arrays!G5","v":""},{"$f":"Arrays!G6","v":""},{"$f":"Arrays!G7","v":"Y"},{"$f":"Arrays!G8","v":""},{"$f":"Arrays!G9","v":""},{"$f":"Arrays!G10","v":""},{"$f":"Arrays!G11","v":"N"},{"$f":"Arrays!G12","v":""},{"$f":"Arrays!G13","v":""},{"$f":"Arrays!G14","v":""},{"$f":"Arrays!G15","v":""},{"$f":"Arrays!G16","v":""},{"$f":"Arrays!G17","v":""},{"$f":"Arrays!G18","v":""},{"$f":"Arrays!G19","v":""},null,null,null,null,{"$f":"$AE$90","v":1},null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AQ$613:$AQ$622=\"\",\"\",IF(OR($AQ$613:$AQ$622='Menu Data'!$A$87),\"Yes\",\"No\"))","v":""}]
[null,null,"Notification only:",null,null,null,null,null,{"$f":"Arrays!H2","v":"N"},{"$f":"Arrays!H3","v":""},{"$f":"Arrays!H4","v":""},{"$f":"Arrays!H5","v":""},{"$f":"Arrays!H6","v":""},{"$f":"Arrays!H7","v":"N"},{"$f":"Arrays!H8","v":""},{"$f":"Arrays!H9","v":""},{"$f":"Arrays!H10","v":""},{"$f":"Arrays!H11","v":"Y"},{"$f":"Arrays!H12","v":""},{"$f":"Arrays!H13","v":""},{"$f":"Arrays!H14","v":""},{"$f":"Arrays!H15","v":""},{"$f":"Arrays!H16","v":""},{"$f":"Arrays!H17","v":""},{"$f":"Arrays!H18","v":""},{"$f":"Arrays!H19","v":""},null,null,null,null,{"$f":"$AE$90","v":1}]
[null,null,"Overall amendment type:",null,null,null,null,null,{"$f":"Arrays!$E$53","v":"Substantial for review"},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$90","v":1}]
[null,null,"Overall Category:",null,null,null,null,null,{"$f":"Arrays!$E$23","v":"A"},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$90=0,0,$AJ$143)","v":1}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$90=0,0,IF($AE$629=1,1,0))","v":0}]
[null,null,"Please note: This amendment should not be processed via online submission. Please contact the REC directly to submit this amendment. See the \"Submission Guidance\" tab for further information.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$90=0,0,IF(OR($AF$629=1,$AG$629=1),1,0))","v":0},{"$f":"IF(AND($AE$57=1,$AF$57=1),1,0)","v":0},{"$f":"IF($AI$83=1,1,IF(OR($M$102='Menu Data'!$C$72,$M$151='Menu Data'!$C$72,$M$200='Menu Data'!$C$72,$M$249='Menu Data'!$C$72,$M$298='Menu Data'!$C$72,$M$347='Menu Data'!$C$72,$M$396='Menu Data'!$C$72,$M$445='Menu Data'!$C$72,$M$494='Menu Data'!$C$72,$M$543='Menu Data'!$C$72),1,0))","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$629=1,1,IF($AE$90=0,0,IF(OR($AE$632=1,$AE$634=1),1,0)))","v":0}]
[null,null,"For office use:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$90=0,0,IF(OR($AE$632=1,$AE$634=1),1,0))","v":0}]
[null,null,"New nation(s):",null,null,null,null,null,{"$f":"IF(AND(AF632=\"\",AG632=\"\",AH632=\"\",AI632=\"\"),\"\",AM632)","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$90=0,0,IF(OR($AF$632<>\"\",$AG$632<>\"\",$AH$632<>\"\",$AI$632<>\"\"),1,0))","v":0},{"$f":"IF(AND($AF$76=FALSE,$AF$77=TRUE),\"England\",\"\")","v":""},{"$f":"IF(AND($AG$76=FALSE,$AG$77=TRUE),\"Wales\",\"\")","v":""},{"$f":"IF(AND($AH$76=FALSE,$AH$77=TRUE),\"Scotland\",\"\")","v":""},{"$f":"IF(AND($AI$76=FALSE,$AI$77=TRUE),\"Northern Ireland\",\"\")","v":""},{"$f":"IF(AND($AF$632<>\"\")*OR($AG$632<>\"\",$AH$632<>\"\",$AI$632<>\"\"),\"; \",\"\")","v":""},{"$f":"IF(AND($AG$632<>\"\")*OR($AH$632<>\"\",$AI$632<>\"\"),\"; \",\"\")","v":""},{"$f":"IF(AND($AH$632<>\"\",$AI$632<>\"\"),\"; \",\"\")","v":""},{"$f":"CONCATENATE(\"This amendment adds new participating nation(s) for the first time: \",$AF$632,$AJ$632,$AG$632,$AK$632,$AH$632,$AL$632,$AI$632,\". Ensure that HARP is updated and the relevant national coordinating function(s) are notified.\")","v":"This amendment adds new participating nation(s) for the first time: . Ensure that HARP is updated and the relevant national coordinating function(s) are notified."}]
[null,null,"Adults lacking capacity in new nation(s):",null,null,null,null,null,{"$f":"IF(AND(AF633=\"\",AG633=\"\",AH633=\"\",AI633=\"\"),\"\",AM633)","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AI$82=1,1,IF(COUNTIF(Arrays!$AO$8:$AQ$98,1),1,0))","v":0},{"$f":"IF(OR($AJ$82=1,Arrays!$AO$99=1),\"England\",\"\")","v":""},{"$f":"IF(OR($AK$82=1,Arrays!$AP$99=1),\"Wales\",\"\")","v":""},{"$f":"IF(OR(AL82=1,Arrays!AQ99=1),\"Scotland\",\"\")","v":""},{"$f":"IF(OR($AM$82=1,Arrays!$AR$99=1),\"Northern Ireland\",\"\")","v":""},{"$f":"IF(AND($AF$633<>\"\")*OR($AG$633<>\"\",$AH$633<>\"\",$AI$633<>\"\"),\"; \",\"\")","v":""},{"$f":"IF(AND($AG$633<>\"\")*OR($AH$633<>\"\",$AI$633<>\"\"),\"; \",\"\")","v":""},{"$f":"IF(AND($AH$633<>\"\",$AI$633<>\"\"),\"; \",\"\")","v":""},{"$f":"CONCATENATE(\"This amendment includes adults who lose/lack capacity for the first time in: \",AF633,AJ633,AG633,AK633,AH633,AL633,AI633,\". The original REC review was undertaken in: \",'Submission Guidance'!AG38,\". Consider whether a new REC review is required to cover the new nation(s) being added and advise the applicant.\")","v":"This amendment includes adults who lose/lack capacity for the first time in: . The original REC review was undertaken in: England. Consider whether a new REC review is required to cover the new nation(s) being added and advise the applicant."}]
[null,null,"Update HARP:",null,null,null,null,null,"This amendment may involve an update to contact details or other project details. Ensure that HARP is updated with the current details. If this is the only change, no further study-wide review is required.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$90=0,0,IF(Arrays!$AS$99=1,1,0))","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$90=0,0,IF(OR($AE$632=1,$AE$634=1,$AE$633=1,$AE$636=1),1,0))","v":0}]
[null,null,"This amendment relates to:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$90=0,0,IF(AND($AE$91=1,$AF$91=4)*OR($I$626='Menu Data'!$A$22,$I$626='Menu Data'!$A$23,$I$626='Menu Data'!$A$24),1,0))","v":0}]
[null,null,"Part 1:",null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AQ$623","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$636","v":0}]
[null,null,"Part 2:",null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AQ$624","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$636","v":0}]
[null,null,"Notification for authorisation to the competent authority (MHRA - Medicines):",null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($J$624=\"\",\"\",IF($J$624='Menu Data'!$A$30,\"Yes\",\"No\"))","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"Notification for an opinion to the ethics committee (REC):",null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($I$624=\"\",\"\",IF($I$624='Menu Data'!$A$30,\"Yes\",\"No\"))","v":"Yes"},null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
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[null,null,"Please note: As this is a non-substantial amendment to a CTIMP under the CWoW pilot, this amendment should not be processed\nvia online submission. Please see the \"Submission Guidance\" tab for further information.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$90=0,0,IF(AND($AE$91=1,$AF$91=4)*OR($I$626='Menu Data'!$A$25,$I$626='Menu Data'!$A$26),1,0))","v":0}]
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[null,"Please note: The information displayed on this page will update based on the selections made in the amendment tool so that the submission guidance is tailored to the amendment being made.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
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[null,"Submitting the amendment to REC",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$8=1,0,$AF$6)","v":0},{"$f":"IF(OR('Amendment Tool'!AF53=1,'Amendment Tool'!AF54=1),1,0)","v":1}]
[null,"Submitting the amendment for NHS/HSC review",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$8=1,0,$AF$7)","v":0},{"$f":"IF(OR('Amendment Tool'!$AF$71=1,'Amendment Tool'!$AF$72=1),1,0)","v":1}]
[null,"Submitting the amendment to REC and for NHS/HSC review",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AF$6=1,$AF$7=1),1,0)","v":1}]
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[null,null,"Please enter the full details about the amendment in the amendment tool before checking here for the submission guidance.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR($AE$12=1,$AE$13=1,$AE$14=1,$AE$15=1,$AE$16=1),0,IF('Amendment Tool'!$M$102=\"\",1,0))","v":0}]
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[null,null,"The answers in the Amendment Tool indicate that REC and NHS/HSC review are being sought for the first time. Due to the complex nature of this change, please seek individual advice on how to handle this amendment by emailing amendments@hra.nhs.uk",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF('Amendment Tool'!$AE$84=1,1,0)","v":0}]
[null,null,"The answers in the Amendment Tool indicate that MoDREC review is being sought for the first time. Due to the complex nature of this change, please seek individual advice on how to handle this amendment by emailing modrec@mail.dstl.gov.uk",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF('Amendment Tool'!$AE$85=1,1,0)","v":0}]
[null,null,"The answers in the Amendment Tool indicate that this is an amendment to a research tissue bank. This tool is not currently intended for processing amendments to research tissue banks. Please use the forms available in IRAS to submit the amendment.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF('Amendment Tool'!$AE$86=1,1,0)","v":0}]
[null,null,"The answers in the Amendment Tool indicate that this is an amendment to a research database. This tool is not currently intended for processing amendments to research tissue banks. Please use the forms available in IRAS to submit the amendment.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF('Amendment Tool'!$AE$87=1,1,0)","v":0}]
[null,null,"The answers in the Amendment Tool indicate that REC and NHS/HSC review are not applicable for this study, so there is no need to submit an amendment for these reviews.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR($AE$12=1,$AE$13=1,$AE$14=1,$AE$15=1),0,IF(AND('Amendment Tool'!$AF$50=1)*OR('Amendment Tool'!$AF$53=1,'Amendment Tool'!$AF$71=1),0,1))","v":0}]
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[null,null,"Your amendment is classed as \"non-notifiable\", meaning there is no requirement to submit the amendment for NHS/HSC review",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(Arrays!$E$53=Arrays!$A$58,1,0)","v":0}]
[null,null,"Your amendment is classed as \"substantial\" and REC and/or NHS/HSC review is required. Please follow this link for guidance on how to submit this amendment via IRAS. ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(Arrays!$E$53=Arrays!$A$53,Arrays!$E$53=Arrays!$A$55),1,0)","v":1}]
[null,null,"Your amendment is classed as \"substantial for information\", meaning that it is a substantial amendment for the competent authority (MHRA - medicines), but it should be submitted for information only for REC and/or NHS/HSC review. Please follow this link for guidance on how to submit this amendment via IRAS. ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(Arrays!$E$53=Arrays!$A$54,1,0)","v":0}]
[null,null,"Your amendment is classed as \"non-substantial\", meaning NHS/HSC review is required. Please follow this link for guidance on how to submit this amendment via IRAS. ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(Arrays!$E$53=Arrays!$A$56,1,0)","v":0}]
[null,null,"Your amendment is classed as \"non-substantial, no study-wide review required\". These amendments should be submitted for information only but NHS/HSC review is not required. Please follow this link for guidance on how to submit this amendment via IRAS. ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(Arrays!$E$53=Arrays!$A$57,1,0)","v":0}]
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[null,null,"Your amendment is a substantial amendments to a clinical trial of an investigational medicinal product (CTIMP) under the combined ways of working (CWoW) pilot: Please submit this amendment via the process outlined in the guidance here, including a copy of the locked amendment tool. There is no need to submit to the REC separately.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$10=1,0,IF(AND('Amendment Tool'!$AE$61=1,'Amendment Tool'!$AF$61=1)*OR(Arrays!$G$2='Menu Data'!$A$30,Arrays!$G$3='Menu Data'!$A$30),1,0))","v":0}]
[null,null,"Your amendment is a non-substantial amendment to a clinical trial of an investigational medicinal product (CTIMP) under the combined ways of working (CWoW) pilot: Please submit this amendment via the process outlined in the guidance here. This amendment should not be submitted via the online submission process.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$10=1,0,IF(AND('Amendment Tool'!$AE$61=1,'Amendment Tool'!$AF$61=1,Arrays!$G$2<>'Menu Data'!$A$30,Arrays!$G$3<>'Menu Data'!$A$30)*OR(Arrays!$H$2='Menu Data'!$A$30,Arrays!$H$3='Menu Data'!$A$30),1,0))","v":0}]
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[null,"REC review of amendments relating to adults who lose/lack capacity",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR($AE$29=1,$AE$33=1),1,0)","v":0}]
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[null,null,"Amendments to a study that already includes adults who lose/lack capacity",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND(Arrays!$AM$99=1)*OR(Arrays!$AK$99=1,Arrays!AL99=1,Arrays!$AN$99=1),1,0)","v":0}]
[null,null,{"$f":"CONCATENATE(\"The answers in the amendment tool indicate\",\" that this amendment changes the existing arrangements for adults who lose/lack capacity in \",AK30,\" and Scotland.\")","v":"The answers in the amendment tool indicate that this amendment changes the existing arrangements for adults who lose/lack capacity in  and Scotland."},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$29","v":0},{"$f":"IF(Arrays!$AK$99=1,\"England\",\"\")","v":""},{"$f":"IF(AND(AF30<>\"\",AH30<>\"\"),\", \",\"\")","v":""},{"$f":"IF(Arrays!$AL$99=1,\"Wales\",\"\")","v":""},{"$f":"IF(AND(AH30<>\"\",AJ30<>\"\"),\", \",\"\")","v":""},{"$f":"IF(Arrays!$AN$99=1,\"Northern Ireland\",\"\")","v":""},{"$f":"CONCATENATE($AF$30,$AG$30,$AH$30,$AI$30,$AJ$30)","v":""}]
[null,null,"Please note: this will be an amendment to two different studies, as this activity would have required separate REC reviews originally: one for England, Wales and Northern Ireland, and another for Scotland. Each application submitted to each REC in the UK will have its own IRAS project ID and REC reference numbers.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$29","v":0}]
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[null,null,"Inclusion of adults who lose/lack capacity for the first time",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(COUNTIF(AE36:AE47,1),1,0)","v":0}]
[null,null,"The answers in the amendment tool indicate that this amendment may include adults who lose/lack capacity in one or more nations for the first time. Due to differences in the REC review requirements across the UK for studies involving adults lacking capacity, this change may require a new and separate REC review to cover the new nation(s) being added:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$33","v":0}]
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[null,null,{"$f":"CONCATENATE($AK$36,\":\")","v":":"},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AK$36<>\"\",1,0)","v":0},{"$f":"IF(OR(Arrays!$AO$99=1,'Amendment Tool'!$AJ$82=1),\"England\",\"\")","v":""},{"$f":"IF(AF36=\"\",\"\",IF(AND(AF36<>\"\",AH36<>\"\",AJ36<>\"\"),\", \",IF(AND(AF36<>\"\")*OR(AH36<>\"\",AJ36<>\"\"),\" and \",\"\")))","v":""},{"$f":"IF(OR(Arrays!$AP$99=1,'Amendment Tool'!$AK$82=1),\"Wales\",\"\")","v":""},{"$f":"IF(AND(AF36=\"\",AH36=\"\"),\"\",IF(AND(AH36<>\"\",AJ36<>\"\"),\" and \",\"\"))","v":""},{"$f":"IF(OR(Arrays!AR99=1,'Amendment Tool'!$AM$82=1),\"Northern Ireland\",\"\")","v":""},{"$f":"CONCATENATE($AF$36,$AG$36,$AH$36,$AI$36,$AJ$36)","v":""}]
[null,null,{"$f":"CONCATENATE(\"The answers in the amendment tool indicate\",\" that this amendment includes adults who lose/lack capacity in \",AK36,\" for the first time. To undertake this activity, the study must have REC review by a flagged REC in England, Wales or Northern Ireland.\")","v":"The answers in the amendment tool indicate that this amendment includes adults who lose/lack capacity in  for the first time. To undertake this activity, the study must have REC review by a flagged REC in England, Wales or Northern Ireland."},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$36","v":0},{"$f":"IF(OR('Amendment Tool'!$AO$77=1,'Amendment Tool'!$AO$81=1),1,0)","v":0}]
[null,null,{"$f":"CONCATENATE(\"The original REC review for this study was undertaken in \",AG38,\", so it may be possible to extend the existing REC opinion to this new activity.\")","v":"The original REC review for this study was undertaken in England, so it may be possible to extend the existing REC opinion to this new activity."},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$36=1,$AF$38=1),1,0)","v":0},{"$f":"IF('Amendment Tool'!$AF$59<>3,1,0)","v":1},{"$f":"IF('Amendment Tool'!$AF$59=1,\"England\",IF('Amendment Tool'!$AF$59=2,\"Wales\",IF('Amendment Tool'!$AF$59=3,\"Scotland\",IF('Amendment Tool'!$AF$59=4,\"Northern Ireland\",\"\"))))","v":"England"}]
[null,null,"Please seek guidance from the original REC before proceeding. REC email addresses can be looked up on the HRA website.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$38","v":0}]
[null,null,"The original REC review for this study was undertaken in Scotland, so it will not be possible to extend that REC opinion to this new activity. Unless a separate REC review by a flagged REC in England, Wales or Northern Ireland has been undertaken previously, a new application will be needed to cover this activity.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$36=1,$AF$40=1),1,0)","v":0},{"$f":"IF('Amendment Tool'!$AF$59=3,1,0)","v":0}]
[null,null,"Please seek guidance from the original REC before proceeding. REC email addresses can be looked up on the HRA website.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$40","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$36","v":0}]
[null,null,"Scotland:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(Arrays!$AQ$99=1,'Amendment Tool'!$AL$82=1),1,0)","v":0}]
[null,null,"The answers in the amendment tool indicate that this amendment includes adults who lose/lack capacity in Scotland for the first time. To undertake this activity, the study must have REC review by Scotland A REC.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$43","v":0}]
[null,null,"The original REC review for this study was undertaken in Scotland. If the study was reviewed by Scotland A REC, it may be possible to extend the existing REC opinion to this new activity. If not, then a new application to Scotland A REC will be needed.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$43=1,$AF$45=1),1,0)","v":0},{"$f":"IF('Amendment Tool'!$AF$59=3,1,0)","v":0}]
[null,null,"Please seek guidance from the original REC before proceeding. REC email addresses can be looked up on the HRA website.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$45","v":0}]
[null,null,{"$f":"CONCATENATE(\"The original REC review for this study was undertaken in \",AG38,\", so it will not be possible to extend that REC opinion to this new activity. Unless a separate REC review by a Scotland A REC has been undertaken previously\",\", a new application will be needed to cover this activity.\")","v":"The original REC review for this study was undertaken in England, so it will not be possible to extend that REC opinion to this new activity. Unless a separate REC review by a Scotland A REC has been undertaken previously, a new application will be needed to cover this activity."},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$43=1,$AF$47=1),1,0)","v":0},{"$f":"IF('Amendment Tool'!$AF$59<>3,1,0)","v":1}]
[null,null,"Please seek guidance from the original REC before proceeding. REC email addresses can be looked up on the HRA website.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$47","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$43","v":0}]
[null,null,"Please note: An amendment that is adding adults who lose/lack capacity to a project in one or more nations for the first time must be submitted via the process outlined in the guidance here. This amendment should not be submitted via the online submission process. ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$33","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$33","v":0}]
[null,"REC review of modified amendments",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND('Amendment Tool'!$AE$57=1,'Amendment Tool'!$AF$57=1),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$52","v":0}]
[null,null,"Please note: As this is a submission of a modified amendment, this amendment must be submitted via the process outlined in the specific guidance here. This amendment should not be submitted via the online submission process. ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$52","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"Updates required to the original IRAS form",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(COUNTIF($AE$59:$AE$71,1),1,0)","v":0}]
[null,null,"The answers in the amendment tool indicate that this amendment will require an update to the information about the study on the original IRAS form:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$56","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$56","v":0}]
[null,"Ionising radiation information to be provided to the REC:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$10=1,0,IF(OR($AF$59=1,$AG$59=1),1,0))","v":0},{"$f":"IF(OR('Amendment Tool'!$M$101='Menu Data'!$A$14,'Amendment Tool'!$M$150='Menu Data'!$A$14,'Amendment Tool'!$M$199='Menu Data'!$A$14,'Amendment Tool'!$M$248='Menu Data'!$A$14,'Amendment Tool'!$M$297='Menu Data'!$A$14,'Amendment Tool'!$M$346='Menu Data'!$A$14,'Amendment Tool'!$M$395='Menu Data'!$A$14,'Amendment Tool'!$M$444='Menu Data'!$A$14,'Amendment Tool'!$M$493='Menu Data'!$A$14,'Amendment Tool'!$M$542='Menu Data'!$A$14),1,0)","v":0},{"$f":"IF(OR('Amendment Tool'!$M$101='Menu Data'!$A$7,'Amendment Tool'!$M$150='Menu Data'!$A$7,'Amendment Tool'!$M$199='Menu Data'!$A$7,'Amendment Tool'!$M$248='Menu Data'!$A$7,'Amendment Tool'!$M$297='Menu Data'!$A$7,'Amendment Tool'!$M$346='Menu Data'!$A$7,'Amendment Tool'!$M$395='Menu Data'!$A$7,'Amendment Tool'!$M$444='Menu Data'!$A$7,'Amendment Tool'!$M$493='Menu Data'!$A$7,'Amendment Tool'!$M$542='Menu Data'!$A$7),1,0)","v":0}]
[null,null,"This amendment includes changes to the research exposures in the study. Part B Section 3 of IRAS should be updated by the appropriate Medical Physics Expert(s) (MPE) and Clinical Radiation Expert(s) (CRE) and provided to the REC as part of the substantial amendment submission. Please note that the MPE and CRE reviews in IRAS can be provided through the Radiation Assurance service if the study already has Radiation Assurance or if the amendment is adding research exposures to the study for the first time. Further information on eligible study types is available",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$59","v":0}]
[null,null,"on the IRAS website.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$59","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$59","v":0}]
[null,"Human tissue information to be provided to the REC:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR('Amendment Tool'!$AH$102='Menu Data'!$C$144,'Amendment Tool'!$M$151='Menu Data'!$C$144,'Amendment Tool'!$M$200='Menu Data'!$C$144,'Amendment Tool'!$M$249='Menu Data'!$C$144,'Amendment Tool'!$M$298='Menu Data'!$C$144,'Amendment Tool'!$M$347='Menu Data'!$C$144,'Amendment Tool'!$M$396='Menu Data'!$C$144,'Amendment Tool'!$M$445='Menu Data'!$C$144,'Amendment Tool'!$M$494='Menu Data'!$C$144,'Amendment Tool'!$M$543='Menu Data'!$C$144),1,0)","v":0}]
[null,null,"This amendment adds the use or storage of human tissue samples under the relevant legislation for Human Tissue for the first time. An updated version of the IRAS form for the study should be provided, with Part B Section 4 completed to describe the arrangements regarding the Human Tissue.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$63","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$63","v":0}]
[null,"Change of Chief Investigator (CI) authorisation:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR('Amendment Tool'!$AH$102='Menu Data'!$C$107,'Amendment Tool'!$M$151='Menu Data'!$C$107,'Amendment Tool'!$M$200='Menu Data'!$C$107,'Amendment Tool'!$M$249='Menu Data'!$C$107,'Amendment Tool'!$M$298='Menu Data'!$C$107,'Amendment Tool'!$M$347='Menu Data'!$C$107,'Amendment Tool'!$M$396='Menu Data'!$C$107,'Amendment Tool'!$M$445='Menu Data'!$C$107,'Amendment Tool'!$M$494='Menu Data'!$C$107,'Amendment Tool'!$M$543='Menu Data'!$C$107),1,0)","v":0}]
[null,null,"The new Chief Investigator should authorise the CI declaration page (D1) from the original IRAS form.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$66","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$66","v":0}]
[null,"Change of sponsor:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR('Amendment Tool'!$AH$102='Menu Data'!$C$179,'Amendment Tool'!$M$151='Menu Data'!$C$179,'Amendment Tool'!$M$200='Menu Data'!$C$179,'Amendment Tool'!$M$249='Menu Data'!$C$179,'Amendment Tool'!$M$298='Menu Data'!$C$179,'Amendment Tool'!$M$347='Menu Data'!$C$179,'Amendment Tool'!$M$396='Menu Data'!$C$179,'Amendment Tool'!$M$445='Menu Data'!$C$179,'Amendment Tool'!$M$494='Menu Data'!$C$179,'Amendment Tool'!$M$543='Menu Data'!$C$179),1,0)","v":0}]
[null,null,"The new sponsor should authorise the sponsor declaration page (D2) from the original IRAS form.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$69","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$69","v":0}]
[null,null,"The amendment still needs to be notified to other review bodies as detailed later in this guidance.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($AE$18=0,$AE$100=1),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$72","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,"Notifying participating organisations",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(COUNTIF(AE79:AE95,1),1,0)","v":1}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$75","v":1}]
[null,null,"Affected participating NHS/HSC organisations should be notified about the amendment once the amendment submission has been validated. Please see below for additional country specific guidance about how to notify participating NHS/HSC organisations about the amendment:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$75","v":1}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$75","v":1}]
[null,null,"The answers in the amendment tool indicate that this study has been processed via Pharmacy Assurance. There could be implications for the information contained in the pharmacy technical review form based on the changes brought in by this amendment, which could have an impact on capacity and capability of participating organisations. Please see the guidance on the IRAS Help pages about which changes could impact on the pharmacy technical review form. There is also a Pharmacy Assurance Amendment Site Notification Form available that can be used to help notify participating organisations about this.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND('Amendment Tool'!$AE$62=1,'Amendment Tool'!$AF$62=1),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$79","v":0}]
[null,null,"England and Wales:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(Arrays!$G$11<>\"\",Arrays!$H$11<>\"\"),1,0)","v":1}]
[null,null,"Please disseminate the information about the amendment directly to affected NHS organisations in England and Wales as required.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$81","v":1}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$81","v":1}]
[null,null,"Scotland: ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR($AE$85=1,$AE$86=1),1,0)","v":0}]
[null,null,"As there is only a single-centre in Scotland, please submit the amendment documentation directly to the NHS Board concerned.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$92=1,0,IF(AND($AF$85=1)*(OR(Arrays!$G$15<>\"\",Arrays!$H$15<>\"\")),1,0))","v":0},{"$f":"IF(AND('Amendment Tool'!$AE$78=1,'Amendment Tool'!$AF$78=1),1,0)","v":0}]
[null,null,"As there are multiple participating organisations, the Coordinating Function will notify participating NHS Health Board Research Offices in Scotland on your behalf following online submission of the amendment. However, as a Sponsor responsibility, please continue to send the amendment documentation directly to the study delivery team at the participating research sites in Scotland",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$92=1,0,IF(AND($AF$85=0)*(OR(Arrays!$G$15='Menu Data'!$A$30,Arrays!$H$15='Menu Data'!$A$30)),1,0))","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$84","v":0}]
[null,null,"Northern Ireland: ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR($AE$89=1,$AE$90=1),1,0)","v":0}]
[null,null,"As there is only a single-centre in Northern Ireland, please submit the amendment documentation directly to the HSC Trust/organisation concerned.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$92=1,0,IF(AND($AF$89=1)*(OR(Arrays!$G$19<>\"\",Arrays!$H$19<>\"\")),1,0))","v":0},{"$f":"IF(AND('Amendment Tool'!$AE$79=1,'Amendment Tool'!$AF$79=1),1,0)","v":0}]
[null,null,"As there are multiple participating organisations, the Coordinating Function will notify participating HSC Trusts Research Offices in Northern Ireland on your behalf following online submission of the amendment. However, as a Sponsor responsibility, please continue to send the amendment documentation directly to the study delivery team at the participating research sites in Northern Ireland.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$92=1,0,IF(AND($AF$89=0)*(OR(Arrays!$G$19='Menu Data'!$A$30,Arrays!$H$19='Menu Data'!$A$30)),1,0))","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$88","v":0}]
[null,null,"Please note: while this non-notifiable amendment should not be submitted for NHS/HSC review, it may need to be notified to participating organisation (e.g. Principal Investigator (PI), research teams, local NHS/HSC R&D offices) so that records at the organisation can be updated. Where this is the case, the local NHS/HSC R&D offices are not expected to review and categorise the amendment.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(Arrays!$E$53=Arrays!$A$58,1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$92","v":0}]
[null,null,"Please ensure complete amendment information is disseminated to all non-NHS/HSC organisations affected by this amendment. ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF('Amendment Tool'!$AF$73=1,1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$94","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$75=0,0,1)","v":1}]
[null,"Submitting the amendment to other national review bodies",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,"This amendment does not need to be submitted to any other national review bodies.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$100=1,0,1)","v":1}]
[null,null,"This amendment should be notified to the following national review bodies:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(COUNTIF($AE$102:$AE$176,1),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,"UK wide review bodies",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(COUNTIF($AE$104:$AE$142,1),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$102","v":0}]
[null,"Notification of amendment to MHRA Medicines",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(Arrays!$G$3='Menu Data'!$A$30,1,0)","v":0}]
[null,null,"As this is a substantial amendment to a clinical trial of an investigational medicinal product (CTIMP), it must be notified to MHRA Medicines. Substantial amendments to CTIMPs must be notified using the European Commission Form (Annex 2). The \"Annex 2\" tab will assist in completing this form based on the answers entered into the amendment tool. Copies of this form are available on the EudraCT website.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$104","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"Further guidance about procedures for notifying substantial amendments to MHRA Medicines is available on the MHRA website.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"Please note: Fees apply to amendments requiring full review by the MHRA. For details on the MHRA's fees please visit here.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"Notification of amendment to MHRA Devices",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(Arrays!$G$4='Menu Data'!$A$30,Arrays!$H$4='Menu Data'!$A$30),1,0)","v":0}]
[null,null,"This amendment to a clinical investigation or other study of a medical device must be notified to MHRA Devices via devices.regulatory@mhra.gov.uk",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$111","v":0}]
[null,null,"Please submit:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"A copy of the completed amendment tool",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"The MHRA reference number for the trial",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"Details of the proposed change(s) to the clinical investigation plan or design of the device",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"The reason for the change(s) ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"A signed statement by or on behalf of the manufacturer that the proposed change(s) do not predictably increase the risk to the patient, user or third party",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"Where files are too large to be emailed, amendments should be submitted on CD via post (3 copies, each copy on a separate CD).",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"Further guidance about MHRA Devices amendments is available on the MHRA website.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"Please note: Fees apply to amendments requiring full review by the MHRA. For details on the MHRA's fees please visit here.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"Notification of amendment to ARSAC",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(Arrays!$G$5='Menu Data'!$A$30,Arrays!$H$5='Menu Data'!$A$30),1,0)","v":0}]
[null,null,"This amendment must be notified to the Administration of Radioactive Substances Advisory Committee (ARSAC) via ARSAC@phe.gov.uk",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$125","v":0}]
[null,null,"Please submit:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$125","v":0}]
[null,null,"A copy of the completed amendment tool",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$125","v":0}]
[null,null,"An updated Preliminary Assessment Form (PRA) from IRAS (only required where there are changes to the number of administrations or procedures involving radioactive substances). Part B Section 3 of IRAS should be updated by the appropriate Medical Physics Expert(s) (MPE) and Clinical Radiation Expert(s) (CRE), and electronic authorisation provided throughout the PRA",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(Arrays!$G$5='Menu Data'!$A$30,1,0)","v":0}]
[null,null,"Any relevant amended documentation",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$125","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$125","v":0}]
[null,null,"Please note: Fees apply to amendments requiring full review by ARSAC. Details of how to pay will be sent to you following submission of the amendment. ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$129","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$132","v":0}]
[null,"Notification of amendment to Radiation Assurance",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF('Amendment Tool'!$M$624='Menu Data'!$A$30,1,0)","v":0}]
[null,null,"This amendment to the research exposures should be notified to Radiation Assurance via radiation.assurance@hra.nhs.uk",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$134","v":0}]
[null,null,"Please submit:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$134","v":0}]
[null,null,"An updated research exposure form",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"An updated IRAS form",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"Any relevant amended documentation (such as protocol, participant information sheet(s), imaging manual)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"Please note: Fees apply to amendments being processed for review through Radiation Assurance. Details of fees and payment processes are available on the HRA website.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"Review bodies in England and Wales",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(COUNTIF($AE$145:$AE$157,1),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$143","v":0}]
[null,"Notification of amendment to CAG",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(Arrays!$G$9='Menu Data'!$A$30,Arrays!$H$9='Menu Data'!$A$30),1,0)","v":0}]
[null,null,"This amendment should be notified to the Confidentiality Advisory Team (CAT) by sending them the completed amendment tool. The CAT will advise if anything further is required for the amendment.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(Arrays!$H$9='Menu Data'!$A$30,1,0)","v":0}]
[null,null,"This amendment must be submitted to the Confidentiality Advisory Group (CAG) for full review. To do this, a CAG amendment form should be completed. Further information and access to the form are available here.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(Arrays!$G$9='Menu Data'!$A$30,1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$145","v":0}]
[null,null,"You can contact the Confidentiality Advice Team via hra.cag@hra.nhs.uk or 020 7972 2557 if you wish to discuss your amendment pre-submission. ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$145","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$145","v":0}]
[null,"Notification of amendment to HMPPS",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(Arrays!$G$10='Menu Data'!$A$30,Arrays!$H$10='Menu Data'!$A$30),1,0)","v":0}]
[null,null,"This amendment must be notified to Her Majesty’s Prison and Probation Service (HMPPS) via the National Research Coordinator at",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$151","v":0}]
[null,null,"National.Research@noms.gsi.gov.uk",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"Please submit:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"An email explaining the amendment",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"Any relevant amended documentation",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"Review bodies in Scotland",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(COUNTIF($AE$160:$AE$168,1),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$158","v":0}]
[null,"Notification of amendment to PBPP",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(Arrays!$G$13='Menu Data'!$A$30,Arrays!$H$13='Menu Data'!$A$30),1,0)","v":0}]
[null,null,"This amendment must be notified to Public Benefit and Privacy Panel for Health (PBPP). To do this, an amendment request form should be completed.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$160","v":0}]
[null,null,"Further information and access to the form are available here. ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$160","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$160","v":0}]
[null,null,"Further details can be requested by contacting phs.edris@phs.scot or 0131 275 7333. ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$160","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$160","v":0}]
[null,"Notification of amendment to Scottish Prison Service Research Access and Ethics Committee (RAEC)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(Arrays!$G$14='Menu Data'!$A$30,Arrays!$H$14='Menu Data'!$A$30),1,0)","v":0}]
[null,null,"Contact gram.nrspcc@nhs.scot for advice about submitting amendments to SPS (RAEC).",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$166","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$166","v":0}]
[null,"Review bodies in Northern Ireland",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(COUNTIF($AE$171:$AE$176,1),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$169","v":0}]
[null,"Notification of amendment to HSC Data Guardians",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(Arrays!$G$17='Menu Data'!$A$30,Arrays!$H$17='Menu Data'!$A$30),1,0)","v":0}]
[null,null,"This amendment must be reviewed by HSC Data Guardians at the participating HSC Trusts/organisations. The amendment should be submitted to participating HSC Trusts/organisations in Northern Ireland as described above for this review to be undertaken.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$171","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$171","v":0}]
[null,"Notification of amendment to Northern Ireland Prison Service",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(Arrays!$G$18='Menu Data'!$A$30,Arrays!$H$18='Menu Data'!$A$30),1,0)","v":0}]
[null,null,"Contact research.amendments@hscni.net for advice about submitting amendments to the Northern Ireland Prison Service.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$174","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$174","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,"Categorisation information",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,"This amendment does not need to be categorised for implementation in the NHS/HSC.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(Arrays!$E$23=\"\",Arrays!$E$23=Arrays!$A$28),1,0)","v":0}]
[null,null,"This amendment has the following categorisation for implementation in the NHS/HSC:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$180=1,0,1)","v":1}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,"A",null,"This is a Category A amendment, meaning it has implications for, or affects, all participating NHS/HSC organisations hosting the research project.\n\nParticipating NHS/HSC organisations have 35 days to raise any objections, after which if no objections have been raised and any required regulatory approvals are in place, the amendment can be implemented.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(Arrays!$E$23=Arrays!$A$23,1,0)","v":1}]
[null,null,"B",null,"This is a Category B amendment, meaning it has implications for, or affects, specific participating NHS/HSC organisations hosting the research project.\n\nParticipating NHS/HSC organisations have 35 days to raise any objections, after which if no objections have been raised and any required regulatory approvals are in place, the amendment can be implemented.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(Arrays!$E$23=Arrays!$A$25,1,0)","v":0}]
[null,null,"B/C",null,"This is a Category B/C amendment, meaning it includes some changes that in isolation would be Category B (i.e. affecting specific NHS/HSC organisations hosting the research project) and some changes that in isolation would be Category C (i.e. which have no implications that require management or oversight by the participating NHS/HSC organisations hosting the research project). Section 4 of the Amendment Tool will make it clear which changes are Category B and which are Category C.\n\nParticipating NHS/HSC organisations affected by the Category B changes will have 35 days to raise any objections, after which if no objections have been raised and any required regulatory approvals are in place, the amendment can be implemented.\n\nParticipating NHS/HSC organisations affected by the Category C changes should be provided with the amendment for information; the amendment can be implemented as soon as any required regulatory approvals are in place.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(Arrays!$E$23=Arrays!$A$24,1,0)","v":0}]
[null,null,"C",null,"This is a Category C amendment, meaning it has no implications that require management or oversight by the participating NHS/HSC organisations hosting the research project. However, the amendment should still be provided for information, and can be implemented as soon as any required regulatory approvals are in place.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$187=1,0,IF(Arrays!$E$23=Arrays!$A$26,1,0))","v":0}]
[null,null,"C",null,"This is a Category C amendment, meaning it has no implications that require management or oversight by the participating NHS/HSC organisations hosting the research project. However, the amendment should still be provided for information, and can be implemented as soon as any required regulatory approvals are in place.\n\nNote - Updated Investigator Brochure (IB; Clinical Trials of Investigational Medicinal Products (CTIMPs) only): Where the IB update constitutes a non-substantial amendment for REC and MHRA and this is the only amendment (e.g. the update to IB does not give rise to an updated pharmacy manual or protocol) the updated IB should not be submitted for categorisation. These amendments will always be category C and they will not be assessed by NHS/HSC if submitted. The IB should be provided to each participating NHS/HSC organisation.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND('Amendment Tool'!$K$102='Menu Data'!$C$154,'Amendment Tool'!$K$151=0),1,0)","v":0}]
[null,null,"New\nsite",null,"This amendment solely relates to the addition of one or more new participating NHS/HSC organisations to a study. See below for further information about setting up the new participating NHS/HSC organisation(s).",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(Arrays!$E$23=Arrays!$A$27,1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(COUNTIF($AE$183:$AE$188,1),1,0)","v":1}]
[null,"Setting up new participating NHS/HSC organisation(s)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR('Amendment Tool'!$AA$613:$AB$622=Arrays!$A$27),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$190","v":0}]
[null,null,"Please see below for additional country specific guidance about how to implement your amendment:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$190","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$190","v":0}]
[null,"England and Wales: ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(COUNTIF(Arrays!$AH$8:$AH$98,1),1,0)","v":0}]
[null,null,"For studies which already have HRA and HCRW Approval:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$194","v":0}]
[null,null,"You can start the process of setting up at the new participating organisation as soon as you have submitted your amendment. You can open the study when that participating NHS organisation has confirmed capacity and capability (where applicable).",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"For studies which do not yet have HRA and HCRW Approval:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"HRA and HCRW Approval for the initial application is pending and you will receive this in due course. You can start the process of setting up the new participating organisation(s) by sharing the Local Information Pack, but the study cannot open at the participating organisation(s) until HRA and HCRW Approval is in place and the participating organisation(s) have confirmed capacity and capability (where applicable).",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"Scotland",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(COUNTIF(Arrays!$AI$8:$AI$98,1),1,0)","v":0}]
[null,null,"Please start to set up your new participating organisation(s). Participating organisations may not open until NHS management permission is in place.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$201","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$201","v":0}]
[null,"Northern Ireland: ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(COUNTIF(Arrays!$AJ$8:$AJ$98,1),1,0)","v":0}]
[null,null,"You can start the process of setting up at the new participating organisation(s) as soon as you have submitted your amendment and can open the study when that participating HSC organisation has confirmed capacity and capability (where applicable).",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$204","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$AE$204","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,"Further guidance",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,"For further detailed amendment guidance, please visit the IRAS help pages. ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,"The IRAS website also gives guidance on the definition of a research exposure.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(OR(AND('Amendment Tool'!$AE$65=1,'Amendment Tool'!$AF$65=1),(AND('Amendment Tool'!$AE$66=1,'Amendment Tool'!$AF$66=1))),1,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,"If have a query about using the amendment tool please contact amendments please contact amendments@hra.nhs.uk",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,"Where an application to a review body is being made for first time because of an amendment:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,"If your amendment requires an application to be made to a review body for the first time, please contact your Lead R&D Office for guidance on how to proceed. Guidance on preparing and submitting applications is also available on the IRAS Help pages.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF('Amendment Tool'!$AF$71=1,1,0)","v":1}]
[null,null,"Guidance on preparing and submitting applications is available on the IRAS Help pages.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($AE$216=1,0,1)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]

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[]
[]
[]
[null,"This page contains details of all of the possible changes that can be selected in the amendment tool and guidance about when these options will be available (Ctrl + F to search)."]
[]
[null,{"$f":"'Menu Data'!A2","v":"Administrative details for the project "}]
[null,"These options cover changes to the administrative details relating to the study."]
[]
[null,null,"Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff","Contact details - CI or other project staff"]
[null,null,"Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder","Contact details - Funder"]
[null,null,"Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)","Contact details - Insurer (insurance arrangements ongoing)"]
[null,null,"Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative","Contact details - Sponsor or representative"]
[null,null,"Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below","Other administrative change - Please specify in the free text below"]
[null,null,"Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)","Project identification (e.g. change of title, reference numbers)"]
[]
[]
[null,{"$f":"'Menu Data'!A3","v":"Confidential patient information arrangements "}]
[null,"These changes relate specifically to studies involving access to confidential patient information without consent, where the common law duty of confidentiality has been set aside (e.g. under section 251 support in England and Wales, or equivalent mechanisms in Scotland or Northern Ireland). These options are only available when section 1 of the amendment tool has been completed to indicate that the study required REC review and that it involves access to confidential patient information without consent."]
[]
[null,null,"Confidential patient information being accessed without consent for the first time"]
[null,null,"Data controller"]
[null,null,"Data flows"]
[null,null,"Data items"]
[null,null,"Data processor"]
[null,null,"Data sources"]
[null,null,"Duration"]
[null,null,"Other - Please specify in the free text below"]
[null,null,"Purposes of application"]
[]
[]
[null,{"$f":"'Menu Data'!A5","v":"CTIMP IMP "}]
[null,"These changes relate specifically to the arrangements for the IMP in clinical trials of investigational medicinal products (CTIMPs). These options are only available when section 1 of the amendment tool has been completed to indicate that the study required REC review and that it is a CTIMP."]
[]
[null,null,"Change of dosing"]
[null,null,"Change of IMPs"]
[null,null,"Change of mode of administration"]
[null,null,"IMP being added to the study for the first time"]
[null,null,"Other - Please specify in the free text below"]
[null,null,"Temporary alternative arrangements to provide participants with IMP (e.g. delivery directly by courier) where there is no increased risk to the participant"]
[]
[null,"Please note: As the \"other\" option is not specific, it generally carries a high tariff for the review bodies and categorisation (where appropriate). It is better to use the specified options available if at all possible."]
[]
[]
[null,{"$f":"'Menu Data'!A6","v":"CTIMP safety "}]
[null,"These changes relate specifically to the safety arrangements for clinical trials of investigational medicinal products (CTIMPs). These options are only available when section 1 of the amendment tool has been completed to indicate that the study required REC review and that it is a CTIMP."]
[]
[null,null,"Data - New data or interpretation affecting risk/benefit assessment"]
[null,null,"Data - New data or interpretation of relevance for the Investigator "]
[null,null,"Data Monitoring Committee - Update from a data monitoring committee (study should proceed without changes)"]
[null,null,"Data Monitoring Committee - Withdrawal of an independent data monitoring committee"]
[null,null,"Other - Please specify in the free text below"]
[null,null,"Study oversight - Additional safety monitoring, not part of an urgent safety measure, but taken on a precautionary basis"]
[null,null,"Study oversight - Temporary change in arrangements for monitoring (e.g. remote instead of on-site) where the arrangements will not contradict those previously described to the participant and the necessary security arrangements will be in place"]
[null,null,"Study oversight - Change in arrangements for monitoring (e.g. remote instead of on-site) where the new arrangements need to be described in updated information for the participant"]
[null,null,"Study oversight - Reduction in the sponsor’s planned level of monitoring for the study"]
[]
[null,"Please note: As the \"other\" option is not specific, it generally carries a high tariff for the review bodies and categorisation (where appropriate). It is better to use the specified options available if at all possible."]
[]
[]
[null,{"$f":"'Menu Data'!A7","v":"Ionising radiation exposure not involving Radioactive Substances "}]
[null,"These changes relate specifically to exposures to ionising radiation not involving the administration of radioactive substances (which has its own separate set of changes within the amendment tool). These options are only available when section 1 of the amendment tool has been completed to indicate that the study required REC review and that it involves the use of exposures to ionising radiation."]
[]
[null,null,"Addition of a new study population with a different clinical condition for the research exposures"]
[null,null,"Addition or removal of a procedure involving research exposures"]
[null,null,"Changes to the dose of ionising radiation procedures specified by the protocol"]
[null,null,"Changes to the number of research exposures for previously declared research exposures"]
[null,null,"Other - Please specify in the free text below"]
[null,null,"Significant changes to the ionising radiation risk statement in the PIS where the meaning of the text is substantially altered"]
[]
[]
[null,{"$f":"'Menu Data'!A8","v":"Medical Devices and related management arrangements "}]
[null,"These changes relate specifically to clinical investigations or other studies of medical devices. These options are only available when section 1 of the amendment tool has been completed to indicate that the study required REC review and that it involves a medical device."]
[]
[null,null,"Change to device under investigation"]
[null,null,"Changes requested by REC"]
[null,null,"Medical device(s) being added to the study for the first time"]
[null,null,"Other - Please specify in the free text below"]
[null,null,"Protocol/clinical investigation plan/other study documentation - Changes to safety or clinical information relating to medical device"]
[]
[]
[null,{"$f":"'Menu Data'!A10","v":"Other "}]
[null,"This option has been included specifically for changes that may require review by bodies whose applications are managed outside of IRAS e.g. Health and Safety Executive (HSE), Department for Environment and Rural Affairs (DEFRA). If the change does not involve such review bodies, then this option should not be selected."]
[]
[null,null,"E.g. Genetically Modified Organisms (HSE/DEFRA) - Please specify in the free text below"]
[]
[]
[null,{"$f":"'Menu Data'!A11","v":"Participant Procedures "}]
[null,"These changes relate to the procedures that involve the study participants. The options available vary depending on the selections made in section 1 of\nthe amendment tool:\n1 These options are only available when section 1 of the amendment tool has been completed to indicate that the study required REC review.\n2 These options are only available when section 1 of the amendment tool has been completed to indicate that the study required REC review\n   and that it involves adults lacking capacity."]
[]
[null,null,"Amendment following urgent safety measure(s) taken to protect participants1"]
[null,null,"Mental Capacity - Change to the procedures/arrangements involving adults who lose/lack capacity2"]
[null,null,"Mental Capacity - Involvement of adults who lose/lack capacity for the first time2"]
[null,null,"Other - Please specify in the free text below"]
[null,null,"Participant procedures - minor change that can be implemented within existing resource at participating organisations - Please specify in the free text below"]
[null,null,"Participant procedures - minor change that will have additional resource implications for participating organisations - Please specify in the free text below"]
[null,null,"Participant procedures - significant change that can be implemented within existing resource at participating organisations - Please specify in the free text below"]
[null,null,"Participant procedures - significant change that will have additional resource implications for participating organisations - Please specify in the free text below"]
[null,null,"Recruitment - Change in identification, approach, recruitment or consent of participants"]
[null,null,"Wellbeing - Change relating to the safety, physical or mental integrity of participants, or to the risk/benefit assessment1"]
[]
[null,"Please note: A \"significant change\" is one that is likely to affect to a significant degree any of the following:"]
[null,"(a) the safety or physical or mental integrity of the participants,"]
[null,"(b) the scientific value of the study,"]
[null,"(c) the conduct or management of the trial, or"]
[null,"(d) the quality or safety of any interventions used in the study"]
[]
[null,"Please note: As the \"other\" option is not specific, it generally carries a high tariff for the review bodies and categorisation (where appropriate). It is better to use the specified options available if at all possible."]
[]
[]
[null,{"$f":"'Menu Data'!A12","v":"Participating Organisations "}]
[null,"These changes relate to the participating organisations which are undertaking research activities for a study."]
[]
[null,null,"Addition of new sites undertaking different activities, or a change to activities undertaken by existing sites"]
[null,null,"Addition of sites undertaking the same activities as existing sites"]
[null,null,"Early closure or withdrawal of research sites"]
[null,null,"Other - Please specify in the free text below"]
[null,null,"PICs - Addition of Participant Identification Centres for the first time, or a change to activities undertaken by existing PICs"]
[null,null,"PICs - Addition of Participant Identification Centres undertaking the same activities as existing PICs"]
[null,null,"PICs - Early closure or withdrawal of Participant Identification Centres"]
[]
[null,"Please note: As the \"other\" option is not specific, it generally carries a high tariff for the review bodies and categorisation (where appropriate). It is better to use the specified options available if at all possible."]
[]
[]
[null,{"$f":"'Menu Data'!A13","v":"Prisoners "}]
[null,"These changes relate specifically to the involvement of prisoners or young offenders within the remit of the UK prison services in England, Wales, Scotland or Northern Ireland. These options are only available when section 1 of the amendment tool has been completed to indicate that the study required REC review and that it involves prisoners."]
[]
[null,null,"Other - Please specify in the free text below"]
[null,null,"Prison service is being involved in the study for the first time"]
[]
[]
[null,{"$f":"'Menu Data'!A14","v":"Radioactive Substances "}]
[null,"These changes relate specifically to the administration of radioactive substances requiring review by the Administration of Radioactive Substances Advisory Committee (ARSAC). These options are only available when section 1 of the amendment tool has been completed to indicate that the study required REC review and that it involves administration of radioactive substances."]
[]
[null,null,"Addition of a new study population with a different clinical condition for the administration of radioactive substances (including changing the age of participants)"]
[null,null,"Addition or removal of a procedure involving administration of radioactive substances"]
[null,null,"Changes to the number of administrations of radioactive substances"]
[null,null,"Changes to the radiation risk information in the PIS following changes to the protocol for the administration of radioactive substances"]
[null,null,"Other - Please check with ARSAC before submitting this amendment. Specify in the free text below"]
[]
[]
[null,{"$f":"'Menu Data'!A15","v":"Researchers "}]
[null,"These changes relate to the researchers involved in the study e.g. the Chief Investigator (CI), Principal Investigators (PIs), or other members of the research team. The options available vary depending on the selections made in section 1 of the amendment tool:\n1 These options are only available when section 1 of the amendment tool has been completed to indicate that the study involves prisoners."]
[]
[null,null,"Changes to the research team (other than CIs or PIs)"]
[null,null,"CI - New CI, or temporary arrangements to cover the absence of a CI"]
[null,null,"CI - Possible conflict of interest for CI"]
[null,null,"Other - Please specify in the free text below"]
[null,null,"PI - New PI, or temporary arrangements to cover the absence of a PI"]
[null,null,"PI - Possible conflict of interest for PI"]
[null,null,"Prisons - Change involving PI responsible for the study at the prison service1"]
[null,null,"Prisons - Changes to the research team at the prison service (other than CIs or PIs)1"]
[]
[null,"Please note: As the \"other\" option is not specific, it generally carries a high tariff for the review bodies and categorisation (where appropriate). It is better to use the specified options available if at all possible."]
[]
[]
[null,{"$f":"'Menu Data'!A16","v":"Stop or Restart "}]
[null,"These changes relate to stopping or restarting the study. The options available vary depending on the selections made in section 1 of the amendment tool:\n1 This option is only available when section 1 of the amendment tool has been completed to indicate that the study is non-interventional (e.g. not a CTIMP or medical device study).\n2 These options are only available when section 1 of the amendment tool has been completed to indicate that the study is interventional (e.g. a CTIMP or medical device study).\n3 This option is only available when section 1 of the amendment tool has been completed to indicate that the study is a CTIMP."]
[]
[null,null,"Other - Please specify in the free text below"]
[null,null,"Permanent closure or withdrawal of a non-interventional study1"]
[null,null,"Permanent closure or withdrawal of an interventional study where the arrangements for post-study care will be in line with those previously described to the participant2"]
[null,null,"Permanent closure or withdrawal of an interventional study where the arrangements for post-study care will differ from those previously described to the participant2"]
[null,null,"Restart of study following a temporary halt"]
[null,null,"Temporary halt of CTIMP3"]
[null,null,"Temporary halt of non-CTIMP"]
[null,null,"Temporary halt of non-CTIMP due to COVID-19"]
[]
[null,"Please note: As the \"other\" option is not specific, it generally carries a high tariff for the review bodies and categorisation (where appropriate). It is better to use the specified options available if at all possible."]
[]
[]
[null,{"$f":"'Menu Data'!A17","v":"Study Design "}]
[null,"These changes relate to the study design."]
[]
[null,null,"Background information - Change that affects scientific value of study"]
[null,null,"Data collection, transfer or processing of identifiable participant information - Changes in arrangements or organisations involved (other than the addition of new participating organisations)"]
[null,null,"Endpoint/objective - Change to the endpoint or the main objective"]
[null,null,"Extension to study duration that will have additional resource implications for participating organisations - Please specify in the free text below"]
[null,null,"Extension to study duration that will not have any additional resource implications for participating organisations - Please specify in the free text below"]
[null,null,"Inclusion/exclusion criteria - Minor change unlikely to affect safety or scientific value of study"]
[null,null,"Inclusion/exclusion criteria - Significant change (e.g. to age range) likely to affect safety or scientific value of study"]
[null,null,"New arm - Addition of a study arm or placebo/control group"]
[null,null,"Other minor change to study design that can be implemented within existing resource in place at participating organisations - Please specify in the free text below"]
[null,null,"Other minor change to study design that will have additional resource implications for participating organisations - Please specify in the free text below"]
[null,null,"Other significant change to study design that can be implemented within existing resource in place at participating organisations - Please specify in the free text below"]
[null,null,"Other significant change to study design that will have additional resource implications for participating organisations - Please specify in the free text below"]
[null,null,"Participant numbers - Minor change to sample size"]
[null,null,"Participant numbers - Significant change to sample size"]
[null,null,"Samples - addition of the storage or use of human tissue samples under the relevant legislation on Human Tissue for the first time"]
[null,null,"Samples - minor changes (e.g. to the logistical arrangements for transporting or storing samples)"]
[null,null,"Samples - significant changes (e.g. to the arrangements for removal, storage or use of samples under the relevant legislation on Human Tissue)"]
[]
[null,"Please note: A \"significant change\" is one that is likely to affect to a significant degree any of the following:"]
[null,"(a) the safety or physical or mental integrity of the participants,"]
[null,"(b) the scientific value of the study,"]
[null,"(c) the conduct or management of the trial, or"]
[null,"(d) the quality or safety of any interventions used in the study"]
[]
[]
[null,{"$f":"'Menu Data'!A18","v":"Study Documents "}]
[null,"These changes relate to the study documents.\n1 This option is only available when section 1 of the amendment tool has been completed to indicate that the study is a CTIMP."]
[]
[null,null,"Correction of typographical errors"]
[null,null,"CRF/other study data records - Changes in the documentation used by the research team for recording study data"]
[null,null,"GDPR wording - Accepted wording used verbatim"]
[null,null,"GDPR wording - Unaccepted alternative wording used"]
[null,null,"IB - Annual review (no changes except the last review date)1"]
[null,null,"IB - Changes to the reference safety information (RSI)1"]
[null,null,"IB, SmPC - Non-substantial changes (e.g. that do not affect risk/benefit assessment)1"]
[null,null,"IB, SmPC - Substantial changes (e.g. affecting the risk/benefit assessment)1"]
[null,null,"IMPD - Non-substantial changes1"]
[null,null,"IMPD - Substantial changes1"]
[null,null,"Other minor change to study documents (e.g. information sheets, consent forms, questionnaires, letters) that can be implemented within existing resource in place at participating organisations - Please specify in the free text below"]
[null,null,"Other minor change to study documents (e.g. information sheets, consent forms, questionnaires, letters) that will have additional resource implications for participating organisations - Please specify in the free text below"]
[null,null,"Other significant change to study documents (e.g. information sheets, consent forms, questionnaires, letters) that can be implemented within existing resource in place at participating organisations - Please specify in the free text below"]
[null,null,"Other significant change to study documents (e.g. information sheets, consent forms, questionnaires, letters) that will have additional resource implications for participating organisations - Please specify in the free text below"]
[null,null,"Post trial information for participants (which does not contradict the protocol)"]
[null,null,"Protocol - Non-substantial changes (e.g. not affecting safety or the scientific value of the trial)"]
[null,null,"Protocol - Substantial changes (e.g. affecting safety or the scientific value of the trial)"]
[null,null,"Translations - Addition of translated versions of participant-facing documentation"]
[]
[null,"Please note: A \"significant change\" is one that is likely to affect to a significant degree any of the following:"]
[null,"(a) the safety or physical or mental integrity of the participants,"]
[null,"(b) the scientific value of the study,"]
[null,"(c) the conduct or management of the trial, or"]
[null,"(d) the quality or safety of any interventions used in the study"]
[]
[]
[null,{"$f":"'Menu Data'!A19","v":"Study Management "}]
[null,"These changes relate to the management of the study."]
[]
[null,null,"Contract/agreement arrangements"]
[null,null,"Equipment arrangements"]
[null,null,"Funding arrangements - Changes that do not affect payments to participants/researchers/sites"]
[null,null,"Funding arrangements - Changes to the payments, benefits or incentives to be received by participants"]
[null,null,"Funding arrangements - Changes to the payments, benefits or incentives to be received by researchers/sites"]
[null,null,"Insurance - Changes to insurance or indemnity arrangements"]
[null,null,"Insurance - Renewal with no change to the level or breadth of cover"]
[null,null,"Non-UK countries - Inclusion or withdrawal of an EU Member State or third country"]
[null,null,"Other minor change - Please specify in the free text below"]
[null,null,"Other significant change - Please specify in the free text below"]
[null,null,"Sponsor - Change of Sponsor"]
[null,null,"Sponsor - Change of Sponsor’s legal representative"]
[null,null,"Sponsor delegations - Changes to the internal organisation of the sponsor or persons/organisations to whom tasks have been delegated"]
[]
[null,"Please note: As the \"other\" options are not specific, they generally carry a high tariff for the review bodies and categorisation (where appropriate). It is better to use the specified options available if at all possible."]

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[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,1]
[null,"An Annex 2 form is only used for a substantial amendment to a Clinical Trial of an Investigational Medicinal Product (CTIMP). Based on the current answers in the amendment tool, an Annex 2 form should not be required for the amendment.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND('Amendment Tool'!$AE$60=1,'Amendment Tool'!$AF$60=1)*OR(Arrays!$E$53='Menu Data'!$A$22,Arrays!$E$53='Menu Data'!$A$23,Arrays!$E$53='Menu Data'!$A$24),0,1)","v":1},null,null,null,null,null,1,"United Kingdom"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$R$5","v":1},null,null,null,null,null,2,"Austria"]
[null,"Substantial Amendment Notification Form (Cf. Section 3.7.b of the Detailed guidance on the request to the competent authorities for authorisation of a clinical trial on a medicinal product for human use, the notification of substantial amendments and the declaration of the end of the trial1)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Guidance notes",{"$f":"IF($R$5=0,1,0)","v":0},null,null,null,null,null,3,"Belgium"]
[null,"NOTIFICATION OF A SUBSTANTIAL AMENDMENT TO A CLINICAL TRIAL ON A MEDICINAL PRODUCT FOR HUMAN USE TO THE COMPETENT AUTHORITIES AND  FOR OPINION OF THE ETHICS COMMITTEES IN THE EUROPEAN UNION",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$R$7","v":0},null,null,null,null,null,4,"Bulgaria"]
[null,"For official use:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$R$7","v":0},null,null,null,null,null,5,"Croatia"]
[null,"Date of receiving the request:",null,null,null,null,null,"Grounds for non acceptance/negative opinion:",null,null,null,null,null,null,null,null,"This section does not need to be completed by the applicant.",0,null,null,null,null,null,6,"Republic of Cyprus"]
[null,null,null,null,null,null,null,"Date:",null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,7,"Czech Republic"]
[null,"Date of start of procedure:",null,null,null,null,null,"Authorisation/positive opinion: ",null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,8,"Denmark"]
[null,null,null,null,null,null,null,"Date:",null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,9,"Estonia"]
[null,"Competent authority registration number of the trial:",null,null,null,null,null,"Withdrawal of amendment application:",null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,10,"Finland"]
[null,null,null,null,null,null,null,"Date:",null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,11,"France"]
[null,"Ethics committee registration number of the trial:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,12,"Germany"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,13,"Greece"]
[null,"To be filled in by the applicant:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,14,"Hungary"]
[null,"This form is to be used both for a request to the Competent Authority for authorisation of a substantial amendment and to an Ethics Committee for its opinion on a substantial amendment. Please indicate the relevant purpose in Section A.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,15,"Ireland"]
[null,"A","TYPE OF NOTIFICATION",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,16,"Italy"]
[null,"A.1 Member State in which the substantial amendment is being submitted:",null,null,null,null,null,null,null,null,"United Kingdom",null,null,null,null,null,"Drop down list. UK selected by default.",0,null,null,null,null,null,17,"Latvia"]
[null,"A.2 Notification for authorisation to the competent authority:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick boxes will automatically select based on Section 4 of the tool",0,{"$f":"T22","v":false},{"$f":"IF('Amendment Tool'!$J$624='Menu Data'!$A$30,TRUE,FALSE)","v":false},null,null,null,18,"Lithuania"]
[null,"A.3 Notification for authorisation to the ethics committee:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"T23","v":true},{"$f":"IF('Amendment Tool'!$I$624='Menu Data'!$A$30,TRUE,FALSE)","v":true},null,null,null,19,"Luxembourg"]
[null,"(1) OJ, C82, 30.3.2010, p. 1; hereinafter referred to as 'detailed guidance CT-1'.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,20,"Malta"]
[null,"B","TRIAL IDENTIFICATION (When the amendment concerns more than one trial, repeat this form as necessary.)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,21,"Netherlands"]
[null,"B.1 Does the substantial amendment concern several trials involving the same IMP?2",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick as applicable.",0,false,null,null,null,null,22,"Poland"]
[null,"B.1.1   If yes repeat this section as necessary.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,23,"Portugal"]
[null,"(2) Cf. Section 3.7. of the detailed guidance CT-1.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,24,"Romania"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,null,null,null,25,"Slovakia"]
[null,"B.2 Eudract number:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the Eudract number.",0,null,null,null,null,null,26,"Slovenia"]
[null,"B.3 Full title of the trial:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the title in the field below.",0,null,null,null,null,null,27,"Spain"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Adjust the row height if more space is needed.",0,null,null,null,null,null,28,"Sweden"]
[null,"B.4 Sponsor’s protocol code number, version, and date:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the details in the field below.",0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Adjust the row height if more space is needed.",0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF($R$5=1,0,IF($S$26=FALSE,1,0))","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to duplicate B.2 - B.4",{"$f":"IF($R$5=1,0,IF($S$26=TRUE,1,0))","v":0},false,{"$f":"IF(AND($S$26=TRUE,$S$36=TRUE),TRUE,FALSE)","v":false}]
[null,"B.2 Eudract number:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the Eudract number.",{"$f":"IF($R$5=1,0,IF($T$36=TRUE,1,0))","v":0}]
[null,"B.3 Full title of the trial:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the title in the field below.",{"$f":"$R$37","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Adjust the row height if more space is needed.",{"$f":"$R$37","v":0}]
[null,"B.4 Sponsor’s protocol code number, version, and date:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the details in the field below.",0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Adjust the row height if more space is needed.",0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to duplicate B.2 - B.4",0,false,{"$f":"IF(AND($S$26=TRUE,$T$36=TRUE,$S$42=TRUE),TRUE,FALSE)","v":false}]
[null,"B.2 Eudract number:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the Eudract number.",{"$f":"IF($R$5=1,0,IF($T$42=TRUE,1,0))","v":0}]
[null,"B.3 Full title of the trial:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the title in the field below.",{"$f":"$R$43","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Adjust the row height if more space is needed.",{"$f":"$R$43","v":0}]
[null,"B.4 Sponsor’s protocol code number, version, and date:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the details in the field below.",0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Adjust the row height if more space is needed.",0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to duplicate B.2 - B.4",0,false,{"$f":"IF(AND($S$26=TRUE,$T$42=TRUE,$S$48=TRUE),TRUE,FALSE)","v":false}]
[null,"B.2 Eudract number:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the Eudract number.",{"$f":"IF($R$5=1,0,IF($T$48=TRUE,1,0))","v":0}]
[null,"B.3 Full title of the trial:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the title in the field below.",{"$f":"$R$49","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Adjust the row height if more space is needed.",{"$f":"$R$49","v":0}]
[null,"B.4 Sponsor’s protocol code number, version, and date:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the details in the field below.",0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Adjust the row height if more space is needed.",0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to duplicate B.2 - B.4",0,false,{"$f":"IF(AND($S$26=TRUE,$T$48=TRUE,$S$54=TRUE),TRUE,FALSE)","v":false}]
[null,"B.2 Eudract number:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the Eudract number.",{"$f":"IF($R$5=1,0,IF($T$54=TRUE,1,0))","v":0}]
[null,"B.3 Full title of the trial:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the title in the field below.",{"$f":"$R$55","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Adjust the row height if more space is needed.",{"$f":"$R$55","v":0}]
[null,"B.4 Sponsor’s protocol code number, version, and date:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter the details in the field below.",0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Adjust the row height if more space is needed.",0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"C","IDENTIFICATION OF THE SPONSOR RESPONSIBLE FOR THE REQUEST",null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$R$7","v":0}]
[null,"C.1","Sponsor",null,null,null,null,null,null,null,null,null,null,null,null,null,"Add details as required.",0]
[null,"C.1.1","Organisation:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"C.1.2","Name of person to contact:",null,null,{"$f":"U64","v":""},null,null,null,null,null,null,null,null,null,null,"Tick this box to copy across the name and email address from Section 3 of the tool.",0,false,null,{"$f":"IF($S$64=FALSE,\"\",IF('Amendment Tool'!$K$593=\"\",\"\",'Amendment Tool'!$K$593))","v":""}]
[null,"C.1.3","Address:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"C.1.4","Telephone number:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"C.1.5","Fax number:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"C.1.6","e-mail:",null,null,{"$f":"U68","v":""},null,null,null,null,null,null,null,null,null,null,"Must be a valid email address format.",0,null,null,{"$f":"IF($S$64=FALSE,\"\",IF('Amendment Tool'!$K$594=\"\",\"\",'Amendment Tool'!$K$594))","v":""}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"C.2","Legal representative3 of the sponsor in the European Union for the purpose of this trial (if different from the sponsor)",null,null,null,null,null,null,null,null,null,null,null,null,null,"Add details as required.",0]
[null,"C.2.1","Organisation:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"C.2.2","Name of person to contact:",null,null,{"$f":"U72","v":""},null,null,null,null,null,null,null,null,null,null,"Tick this box to copy across the name and email address from Section 3 of the tool.",0,false,null,{"$f":"IF($S$72=FALSE,\"\",IF('Amendment Tool'!$K$593=\"\",\"\",'Amendment Tool'!$K$593))","v":""}]
[null,"C.2.3","Address:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"C.2.4","Telephone number:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"C.2.5","Fax number:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"C.2.6","e-mail:",null,null,{"$f":"U76","v":""},null,null,null,null,null,null,null,null,null,null,"Must be a valid email address format.",0,null,null,{"$f":"IF($S$72=FALSE,\"\",IF('Amendment Tool'!$K$594=\"\",\"\",'Amendment Tool'!$K$594))","v":""}]
[null,"(3) As stated in Article 19 of Directive 2001/20/EC.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"D","APPLICANT IDENTIFICATION (please tick the appropriate box)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"D.1","Request for the competent authority",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"D.1.1","Sponsor",null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick as applicable.",0,false]
[null,"D.1.2","Legal representative of the sponsor",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,false]
[null,"D.1.3","Person or organisation authorised by the sponsor to make the application",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,false]
[null,"D.1.4","Complete below:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Add details as required.",0]
[null,"D.1.4.1","Organisation:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"D.1.4.2","Name of person to contact:",null,null,{"$f":"U86","v":""},null,null,null,null,null,null,null,null,null,null,"Tick this box to copy across the name and email address from Section 3 of the tool.",0,false,null,{"$f":"IF($S$86=FALSE,\"\",IF('Amendment Tool'!$K$593=\"\",\"\",'Amendment Tool'!$K$593))","v":""}]
[null,"D.1.4.3","Address:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"D.1.4.4","Telephone number:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"D.1.4.5","Fax number:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"D.1.4.6","e-mail:",null,null,{"$f":"U90","v":""},null,null,null,null,null,null,null,null,null,null,"Must be a valid email address format.",0,null,null,{"$f":"IF($S$86=FALSE,\"\",IF('Amendment Tool'!$K$594=\"\",\"\",'Amendment Tool'!$K$594))","v":""}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"D.2","Request for the Ethics Committee",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"D.2.1","Sponsor",null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick as applicable.",0,false]
[null,"D.2.2","Legal representative of the sponsor",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,false]
[null,"D.2.3","Person or organisation authorised by the sponsor to make the application",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,false]
[null,"D.2.4","Investigator in charge of the application if applicable4:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"•","Co-ordinating investigator (for multicentre trial)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,false]
[null,"•","Principal investigator (for single centre trial)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,false]
[null,"D.2.5","Complete below:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Add details as required.",0]
[null,"D.2.5.1","Organisation:",null,null,{"$f":"U100","v":""},null,null,null,null,null,null,null,null,null,null,"Tick this box to copy across the details entered in D.1 above.",0,false,null,{"$f":"IF($S$100=FALSE,\"\",IF($F$85=\"\",\"\",$F$85))","v":""}]
[null,"D.2.5.2","Name of person to contact:",null,null,{"$f":"U101","v":""},null,null,null,null,null,null,null,null,null,null,"Tick this box to copy across the name and email address from Section 3 of the tool.",0,false,null,{"$f":"IF(AND($S$100=FALSE,$S$101=FALSE),\"\",IF($S$100=TRUE,(IF($F$86=\"\",\"\",$F$86)),IF($S$101=TRUE,(IF('Amendment Tool'!$K$593=\"\",\"\",'Amendment Tool'!$K$593)),\"\")))","v":""}]
[null,"D.2.5.3","Address:",null,null,"",null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($S$100=FALSE,\"\",IF($F$87=\"\",\"\",$F$87))","v":""}]
[null,"D.2.5.4","Telephone number:",null,null,"",null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($S$100=FALSE,\"\",IF($F$88=\"\",\"\",$F$88))","v":""}]
[null,"D.2.5.5","Fax number:",null,null,"",null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($S$100=FALSE,\"\",IF($F$89=\"\",\"\",$F$89))","v":""}]
[null,"D.2.5.6","e-mail:",null,null,{"$f":"U105","v":""},null,null,null,null,null,null,null,null,null,null,"Must be a valid email address format.",0,null,null,{"$f":"IF(AND($S$100=FALSE,$S$101=FALSE),\"\",IF($S$100=TRUE,(IF($F$90=\"\",\"\",$F$90)),IF($S$101=TRUE,(IF('Amendment Tool'!$K$594=\"\",\"\",'Amendment Tool'!$K$594)),\"\")))","v":""}]
[null,"(4) According to national legislation.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"E","SUBSTANTIAL AMENDMENT IDENTIFICATION",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"E.1","Sponsor's substantial amendment code number, version, date for the clinical trial concerned:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,{"$f":"$U$110","v":"Substantial amendment 03, 22 February 2021"},null,null,null,null,null,null,null,null,null,null,null,null,null,"Copies the reference and date from Section 1 of the tool. Edit if required.",0,null,null,{"$f":"IF(OR('Amendment Tool'!$M$8=\"\",'Amendment Tool'!$M$9=\"\"),\"\",CONCATENATE('Amendment Tool'!$M$8,\", \",TEXT('Amendment Tool'!$M$9,\"DD MMMM YYYY\")))","v":"Substantial amendment 03, 22 February 2021"}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"E.2","Type of substantial amendment",null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick boxes will automatically select based on the answers in the tool",0]
[null,"E.2.1","Amendment to information in the CT application form",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"IF(OR('Amendment Tool'!$AO$613:$AO$622='Menu Data'!$A$46),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AO$613:$AO$622='Menu Data'!$A$46),FALSE,TRUE)","v":true}]
[null,"E.2.2","Amendment to the protocol",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"IF(OR('Amendment Tool'!$AO$613:$AO$622='Menu Data'!$A$47),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AO$613:$AO$622='Menu Data'!$A$47),FALSE,TRUE)","v":true}]
[null,"E.2.3","Amendment to other documents appended to the initial application form",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,false,{"$f":"IF(OR('Amendment Tool'!$AO$613:$AO$622='Menu Data'!$A$48),FALSE,TRUE)","v":true}]
[null,"E.2.3.1","If yes specify:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Populates automatically based on Section 2 of the tool. Edit if required. Adjust the row height if more space is needed.",0,null,null,null,null,null,null,"A2 type","A2 reason",null,null,"E.2.3/E.3.7","E.2.4/E.3.7","E.2.3/E.3.8","E.2.4/E.3.8"]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($R$7<>0,S115=TRUE,R118=0),1,0)","v":0}]
[null,null,{"$f":"U118","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(C118<>\"\",1,0)","v":0},null,null,{"$f":"IF($AA118=0,\"\",IF($AA118='Menu Data'!$C$154,$W$118,IF($AA118='Menu Data'!$C$155,$W$119,$AA118)))","v":""},null,"Other significant document change that can be implemented within existing resource in place at participating organisations",{"$f":"'Amendment Tool'!$M$101","v":"Participant Procedures "},{"$f":"'Amendment Tool'!$AO$613","v":""},{"$f":"'Amendment Tool'!$AP$613","v":""},{"$f":"IF(Y118='Menu Data'!$A$48,X118,0)","v":0},null,{"$f":"IF(AND($Y118='Menu Data'!$A$48,$Z118='Menu Data'!$A$62),$X118,0)","v":0},{"$f":"IF(AND($Y118='Menu Data'!$A$49,$Z118='Menu Data'!$A$62),$X118,0)","v":0},{"$f":"IF(AND($Y118='Menu Data'!$A$48,$Z118='Menu Data'!$A$63),$X118,0)","v":0},{"$f":"IF(AND($Y118='Menu Data'!$A$49,$Z118='Menu Data'!$A$63),$X118,0)","v":0}]
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[null,"E.2.4","Amendment to other documents or information",null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$R$7","v":0},{"$f":"IF(OR('Amendment Tool'!$AO$613:$AO$622='Menu Data'!$A$49),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AO$613:$AO$622='Menu Data'!$A$49),FALSE,TRUE)","v":true}]
[null,"E.2.4.1","If yes specify:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Populates automatically based on Section 2 of the tool. Edit if required. Adjust the row height if more space is needed.",0]
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[null,null,{"$f":"U151","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(C151<>\"\",1,0)","v":0},null,null,{"$f":"IF($AA151=0,\"\",IF(OR($AA151='Menu Data'!$C$19,$AA151='Menu Data'!$C$102,$AA151='Menu Data'!$C$178),$W$151,IF($AA151='Menu Data'!$C$138,$W$152,IF($AA151='Menu Data'!$C$139,$W$153,$AA151))))","v":""},null,"Other change",null,null,null,{"$f":"IF(Y118='Menu Data'!$A$49,X118,0)","v":0}]
[null,null,{"$f":"U152","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA152=0,\"\",IF(OR($AA152='Menu Data'!$C$19,$AA152='Menu Data'!$C$102,$AA152='Menu Data'!$C$178),$W$151,IF($AA152='Menu Data'!$C$138,$W$152,IF($AA152='Menu Data'!$C$139,$W$153,$AA152))))","v":""},null,"Other significant change to study design that can be implemented within existing resource in place at participating organisations",null,null,null,{"$f":"IF(Y119='Menu Data'!$A$49,X119,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA153=0,\"\",IF(OR($AA153='Menu Data'!$C$19,$AA153='Menu Data'!$C$102,$AA153='Menu Data'!$C$178),$W$151,IF($AA153='Menu Data'!$C$138,$W$152,IF($AA153='Menu Data'!$C$139,$W$153,$AA153))))","v":""},null,"Other significant change to study design that will have additional resource implications for participating organisations",null,null,null,{"$f":"IF(Y120='Menu Data'!$A$49,X120,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA154=0,\"\",IF(OR($AA154='Menu Data'!$C$19,$AA154='Menu Data'!$C$102,$AA154='Menu Data'!$C$178),$W$151,IF($AA154='Menu Data'!$C$138,$W$152,IF($AA154='Menu Data'!$C$139,$W$153,$AA154))))","v":""},null,null,null,null,null,{"$f":"IF(Y121='Menu Data'!$A$49,X121,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA155=0,\"\",IF(OR($AA155='Menu Data'!$C$19,$AA155='Menu Data'!$C$102,$AA155='Menu Data'!$C$178),$W$151,IF($AA155='Menu Data'!$C$138,$W$152,IF($AA155='Menu Data'!$C$139,$W$153,$AA155))))","v":""},null,null,null,null,null,{"$f":"IF(Y122='Menu Data'!$A$49,X122,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA156=0,\"\",IF(OR($AA156='Menu Data'!$C$19,$AA156='Menu Data'!$C$102,$AA156='Menu Data'!$C$178),$W$151,IF($AA156='Menu Data'!$C$138,$W$152,IF($AA156='Menu Data'!$C$139,$W$153,$AA156))))","v":""},null,null,null,null,null,{"$f":"IF(Y123='Menu Data'!$A$49,X123,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA157=0,\"\",IF(OR($AA157='Menu Data'!$C$19,$AA157='Menu Data'!$C$102,$AA157='Menu Data'!$C$178),$W$151,IF($AA157='Menu Data'!$C$138,$W$152,IF($AA157='Menu Data'!$C$139,$W$153,$AA157))))","v":""},null,null,null,null,null,{"$f":"IF(Y124='Menu Data'!$A$49,X124,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA158=0,\"\",IF(OR($AA158='Menu Data'!$C$19,$AA158='Menu Data'!$C$102,$AA158='Menu Data'!$C$178),$W$151,IF($AA158='Menu Data'!$C$138,$W$152,IF($AA158='Menu Data'!$C$139,$W$153,$AA158))))","v":""},null,null,null,null,null,{"$f":"IF(Y125='Menu Data'!$A$49,X125,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA159=0,\"\",IF(OR($AA159='Menu Data'!$C$19,$AA159='Menu Data'!$C$102,$AA159='Menu Data'!$C$178),$W$151,IF($AA159='Menu Data'!$C$138,$W$152,IF($AA159='Menu Data'!$C$139,$W$153,$AA159))))","v":""},null,null,null,null,null,{"$f":"IF(Y126='Menu Data'!$A$49,X126,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA160=0,\"\",IF(OR($AA160='Menu Data'!$C$19,$AA160='Menu Data'!$C$102,$AA160='Menu Data'!$C$178),$W$151,IF($AA160='Menu Data'!$C$138,$W$152,IF($AA160='Menu Data'!$C$139,$W$153,$AA160))))","v":""},null,null,null,null,null,{"$f":"IF(Y127='Menu Data'!$A$49,X127,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA161=0,\"\",IF(OR($AA161='Menu Data'!$C$19,$AA161='Menu Data'!$C$102,$AA161='Menu Data'!$C$178),$W$151,IF($AA161='Menu Data'!$C$138,$W$152,IF($AA161='Menu Data'!$C$139,$W$153,$AA161))))","v":""},null,null,null,null,null,{"$f":"IF(Y128='Menu Data'!$A$49,X128,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA162=0,\"\",IF(OR($AA162='Menu Data'!$C$19,$AA162='Menu Data'!$C$102,$AA162='Menu Data'!$C$178),$W$151,IF($AA162='Menu Data'!$C$138,$W$152,IF($AA162='Menu Data'!$C$139,$W$153,$AA162))))","v":""},null,null,null,null,null,{"$f":"IF(Y129='Menu Data'!$A$49,X129,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA163=0,\"\",IF(OR($AA163='Menu Data'!$C$19,$AA163='Menu Data'!$C$102,$AA163='Menu Data'!$C$178),$W$151,IF($AA163='Menu Data'!$C$138,$W$152,IF($AA163='Menu Data'!$C$139,$W$153,$AA163))))","v":""},null,null,null,null,null,{"$f":"IF(Y130='Menu Data'!$A$49,X130,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA164=0,\"\",IF(OR($AA164='Menu Data'!$C$19,$AA164='Menu Data'!$C$102,$AA164='Menu Data'!$C$178),$W$151,IF($AA164='Menu Data'!$C$138,$W$152,IF($AA164='Menu Data'!$C$139,$W$153,$AA164))))","v":""},null,null,null,null,null,{"$f":"IF(Y131='Menu Data'!$A$49,X131,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA165=0,\"\",IF(OR($AA165='Menu Data'!$C$19,$AA165='Menu Data'!$C$102,$AA165='Menu Data'!$C$178),$W$151,IF($AA165='Menu Data'!$C$138,$W$152,IF($AA165='Menu Data'!$C$139,$W$153,$AA165))))","v":""},null,null,null,null,null,{"$f":"IF(Y132='Menu Data'!$A$49,X132,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA166=0,\"\",IF(OR($AA166='Menu Data'!$C$19,$AA166='Menu Data'!$C$102,$AA166='Menu Data'!$C$178),$W$151,IF($AA166='Menu Data'!$C$138,$W$152,IF($AA166='Menu Data'!$C$139,$W$153,$AA166))))","v":""},null,null,null,null,null,{"$f":"IF(Y133='Menu Data'!$A$49,X133,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA167=0,\"\",IF(OR($AA167='Menu Data'!$C$19,$AA167='Menu Data'!$C$102,$AA167='Menu Data'!$C$178),$W$151,IF($AA167='Menu Data'!$C$138,$W$152,IF($AA167='Menu Data'!$C$139,$W$153,$AA167))))","v":""},null,null,null,null,null,{"$f":"IF(Y134='Menu Data'!$A$49,X134,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA168=0,\"\",IF(OR($AA168='Menu Data'!$C$19,$AA168='Menu Data'!$C$102,$AA168='Menu Data'!$C$178),$W$151,IF($AA168='Menu Data'!$C$138,$W$152,IF($AA168='Menu Data'!$C$139,$W$153,$AA168))))","v":""},null,null,null,null,null,{"$f":"IF(Y135='Menu Data'!$A$49,X135,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA169=0,\"\",IF(OR($AA169='Menu Data'!$C$19,$AA169='Menu Data'!$C$102,$AA169='Menu Data'!$C$178),$W$151,IF($AA169='Menu Data'!$C$138,$W$152,IF($AA169='Menu Data'!$C$139,$W$153,$AA169))))","v":""},null,null,null,null,null,{"$f":"IF(Y136='Menu Data'!$A$49,X136,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA170=0,\"\",IF(OR($AA170='Menu Data'!$C$19,$AA170='Menu Data'!$C$102,$AA170='Menu Data'!$C$178),$W$151,IF($AA170='Menu Data'!$C$138,$W$152,IF($AA170='Menu Data'!$C$139,$W$153,$AA170))))","v":""},null,null,null,null,null,{"$f":"IF(Y137='Menu Data'!$A$49,X137,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA171=0,\"\",IF(OR($AA171='Menu Data'!$C$19,$AA171='Menu Data'!$C$102,$AA171='Menu Data'!$C$178),$W$151,IF($AA171='Menu Data'!$C$138,$W$152,IF($AA171='Menu Data'!$C$139,$W$153,$AA171))))","v":""},null,null,null,null,null,{"$f":"IF(Y138='Menu Data'!$A$49,X138,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA172=0,\"\",IF(OR($AA172='Menu Data'!$C$19,$AA172='Menu Data'!$C$102,$AA172='Menu Data'!$C$178),$W$151,IF($AA172='Menu Data'!$C$138,$W$152,IF($AA172='Menu Data'!$C$139,$W$153,$AA172))))","v":""},null,null,null,null,null,{"$f":"IF(Y139='Menu Data'!$A$49,X139,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA173=0,\"\",IF(OR($AA173='Menu Data'!$C$19,$AA173='Menu Data'!$C$102,$AA173='Menu Data'!$C$178),$W$151,IF($AA173='Menu Data'!$C$138,$W$152,IF($AA173='Menu Data'!$C$139,$W$153,$AA173))))","v":""},null,null,null,null,null,{"$f":"IF(Y140='Menu Data'!$A$49,X140,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA174=0,\"\",IF(OR($AA174='Menu Data'!$C$19,$AA174='Menu Data'!$C$102,$AA174='Menu Data'!$C$178),$W$151,IF($AA174='Menu Data'!$C$138,$W$152,IF($AA174='Menu Data'!$C$139,$W$153,$AA174))))","v":""},null,null,null,null,null,{"$f":"IF(Y141='Menu Data'!$A$49,X141,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA175=0,\"\",IF(OR($AA175='Menu Data'!$C$19,$AA175='Menu Data'!$C$102,$AA175='Menu Data'!$C$178),$W$151,IF($AA175='Menu Data'!$C$138,$W$152,IF($AA175='Menu Data'!$C$139,$W$153,$AA175))))","v":""},null,null,null,null,null,{"$f":"IF(Y142='Menu Data'!$A$49,X142,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA176=0,\"\",IF(OR($AA176='Menu Data'!$C$19,$AA176='Menu Data'!$C$102,$AA176='Menu Data'!$C$178),$W$151,IF($AA176='Menu Data'!$C$138,$W$152,IF($AA176='Menu Data'!$C$139,$W$153,$AA176))))","v":""},null,null,null,null,null,{"$f":"IF(Y143='Menu Data'!$A$49,X143,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA177=0,\"\",IF(OR($AA177='Menu Data'!$C$19,$AA177='Menu Data'!$C$102,$AA177='Menu Data'!$C$178),$W$151,IF($AA177='Menu Data'!$C$138,$W$152,IF($AA177='Menu Data'!$C$139,$W$153,$AA177))))","v":""},null,null,null,null,null,{"$f":"IF(Y144='Menu Data'!$A$49,X144,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA178=0,\"\",IF(OR($AA178='Menu Data'!$C$19,$AA178='Menu Data'!$C$102,$AA178='Menu Data'!$C$178),$W$151,IF($AA178='Menu Data'!$C$138,$W$152,IF($AA178='Menu Data'!$C$139,$W$153,$AA178))))","v":""},null,null,null,null,null,{"$f":"IF(Y145='Menu Data'!$A$49,X145,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA179=0,\"\",IF(OR($AA179='Menu Data'!$C$19,$AA179='Menu Data'!$C$102,$AA179='Menu Data'!$C$178),$W$151,IF($AA179='Menu Data'!$C$138,$W$152,IF($AA179='Menu Data'!$C$139,$W$153,$AA179))))","v":""},null,null,null,null,null,{"$f":"IF(Y146='Menu Data'!$A$49,X146,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA180=0,\"\",IF(OR($AA180='Menu Data'!$C$19,$AA180='Menu Data'!$C$102,$AA180='Menu Data'!$C$178),$W$151,IF($AA180='Menu Data'!$C$138,$W$152,IF($AA180='Menu Data'!$C$139,$W$153,$AA180))))","v":""},null,null,null,null,null,{"$f":"IF(Y147='Menu Data'!$A$49,X147,0)","v":0}]
[null,"E.2.5","This amendment concerns mainly urgent safety measures already implemented5",null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$R$7","v":0},{"$f":"IF(OR('Amendment Tool'!$AO$613:$AO$622='Menu Data'!$A$50),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AO$613:$AO$622='Menu Data'!$A$50),FALSE,TRUE)","v":true}]
[null,"E.2.6","This amendment is to notify a temporary halt of the trial6",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"IF(OR('Amendment Tool'!$AO$613:$AO$622='Menu Data'!$A$51),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AO$613:$AO$622='Menu Data'!$A$51),FALSE,TRUE)","v":true}]
[null,"E.2.7","This amendment is to request a restart of the trial7",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"IF(OR('Amendment Tool'!$AO$613:$AO$622='Menu Data'!$A$52),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AO$613:$AO$622='Menu Data'!$A$52),FALSE,TRUE)","v":true}]
[null,"(5) Cf. Section 3.9. of the detailed guidance CT-1.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"(6) Cf. Section 3.10. of the detailed guidance CT-1.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"(7) Cf. Section 3.10. of the detailed guidance CT-1.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"E.3","Reasons for the substantial amendment",null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick boxes will automatically select based on the answers in the tool",0]
[null,"E.3.1","Changes in safety or integrity of trial subjects",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"IF(OR('Amendment Tool'!$AP$613:$AP$622='Menu Data'!$A$56),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AP$613:$AP$622='Menu Data'!$A$56),FALSE,TRUE)","v":true}]
[null,"E.3.2","Changes in interpretation of scientific documents/value of trial",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"IF(OR('Amendment Tool'!$AP$613:$AP$622='Menu Data'!$A$57),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AP$613:$AP$622='Menu Data'!$A$57),FALSE,TRUE)","v":true}]
[null,"E.3.3","Changes in quality of IMP(s)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"IF(OR('Amendment Tool'!$AP$613:$AP$622='Menu Data'!$A$58),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AP$613:$AP$622='Menu Data'!$A$58),FALSE,TRUE)","v":true}]
[null,"E.3.4","Changes in conduct or management of trial",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"IF(OR('Amendment Tool'!$AP$613:$AP$622='Menu Data'!$A$59),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AP$613:$AP$622='Menu Data'!$A$59),FALSE,TRUE)","v":true}]
[null,"E.3.5","Change or addition of principal investigator(s), co-ordinating investigator",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"IF(OR('Amendment Tool'!$AP$613:$AP$622='Menu Data'!$A$60),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AP$613:$AP$622='Menu Data'!$A$60),FALSE,TRUE)","v":true}]
[null,"E.3.6","Change/addition of site(s)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"IF(OR('Amendment Tool'!$AP$613:$AP$622='Menu Data'!$A$61),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AP$613:$AP$622='Menu Data'!$A$61),FALSE,TRUE)","v":true}]
[null,"E.3.7","Other change",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"IF(OR('Amendment Tool'!$AP$613:$AP$622='Menu Data'!$A$62),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AP$613:$AP$622='Menu Data'!$A$62),FALSE,TRUE)","v":true}]
[null,"E.3.7.1","If yes specify:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Populates automatically based on Section 2 of the tool. Edit if required. Adjust the row height if more space is needed.",{"$f":"$R$7","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($R$7<>0,S195=TRUE,R198=0),1,0)","v":0}]
[null,null,{"$f":"U198","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(C198<>\"\",1,0)","v":0},null,null,{"$f":"IF(AC267=0,\"\",V198)","v":""},"Change to administrative details for the project - see E.2.3.1 for details",{"$f":"'Menu Data'!$A$2","v":"Administrative details for the project "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W198),1,0)","v":0}]
[null,null,{"$f":"U199","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to administrative details for the project - see E.2.4.1 for details",{"$f":"'Menu Data'!$A$2","v":"Administrative details for the project "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W199),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to confidential patient information arrangements - see E.2.3.1 for details",{"$f":"'Menu Data'!$A$3","v":"Confidential patient information arrangements "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W200),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to confidential patient information arrangements - see E.2.4.1 for details",{"$f":"'Menu Data'!$A$3","v":"Confidential patient information arrangements "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W201),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to CTIMP documents - see E.2.3.1 for details",{"$f":"'Menu Data'!$A$4","v":"CTIMP documents "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W202),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to CTIMP documents - see E.2.4.1 for details",{"$f":"'Menu Data'!$A$4","v":"CTIMP documents "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W203),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to CTIMP IMP - see E.2.3.1 for details",{"$f":"'Menu Data'!$A$5","v":"CTIMP IMP "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W204),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to CTIMP IMP - see E.2.4.1 for details",{"$f":"'Menu Data'!$A$5","v":"CTIMP IMP "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W205),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to CTIMP safety - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$6","v":"CTIMP safety "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W206),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to CTIMP safety - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$6","v":"CTIMP safety "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W207),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Ionising radiation exposure not involving Radioactive Substances - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$7","v":"Ionising radiation exposure not involving Radioactive Substances "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W208),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Ionising radiation exposure not involving Radioactive Substances - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$7","v":"Ionising radiation exposure not involving Radioactive Substances "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W209),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Medical Devices and related management arrangements - see E.2.3.1 for details",{"$f":"'Menu Data'!$A$8","v":"Medical Devices and related management arrangements "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W210),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Medical Devices and related management arrangements - see E.2.4.1 for details",{"$f":"'Menu Data'!$A$8","v":"Medical Devices and related management arrangements "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W211),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change involving MoDREC - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$9","v":"MoDREC "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W212),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change involving MoDREC - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$9","v":"MoDREC "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W213),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Other change - see E.2.3.1 for details",{"$f":"'Menu Data'!$A$10","v":"Other "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W214),1,0)","v":0}]
[null,null,{"$f":"U215","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Other change - see E.2.4.1 for details",{"$f":"'Menu Data'!$A$10","v":"Other "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W215),1,0)","v":0}]
[null,null,{"$f":"U216","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Participant Procedures - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$11","v":"Participant Procedures "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W216),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Participant Procedures - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$11","v":"Participant Procedures "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W217),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Participating Organisations - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$12","v":"Participating Organisations "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W218),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Participating Organisations - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$12","v":"Participating Organisations "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W219),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change involving prisoners - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$13","v":"Prisoners "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W220),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change involving prisoners - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$13","v":"Prisoners "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W221),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change involving Radioactive Substances - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$14","v":"Radioactive Substances "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W222),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change involving Radioactive Substances - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$14","v":"Radioactive Substances "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W223),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to researchers - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$15","v":"Researchers "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W224),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to researchers - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$15","v":"Researchers "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W225),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Stop or restart - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$16","v":"Stop or Restart "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W226),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Stop or restart - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$16","v":"Stop or Restart "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W227),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(C228<>\"\",1,0)","v":0},null,null,"","Change to study design - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$17","v":"Study Design "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W228),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to study design - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$17","v":"Study Design "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W229),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to study documents - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$18","v":"Study Documents "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W230),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to study documents - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$18","v":"Study Documents "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W231),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to study management - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$19","v":"Study Management "},null,null,null,null,null,{"$f":"IF(COUNTIF($AC$118:$AC$147,W232),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to study management - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$19","v":"Study Management "},null,null,null,null,null,{"$f":"IF(COUNTIF($AD$118:$AD$147,W233),1,0)","v":0}]
[null,null,{"$f":"U234","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA234=0,\"\",IF($AA234='Menu Data'!$C$19,$W$234,IF($AA234='Menu Data'!$C$154,$W$235,IF($AA234='Menu Data'!$C$155,$W$236,$AA234))))","v":""},null,"Other change",null,null,null,{"$f":"IF(Z118='Menu Data'!$A$62,X118,0)","v":0}]
[null,null,{"$f":"U235","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA235=0,\"\",IF($AA235='Menu Data'!$C$19,$W$234,IF($AA235='Menu Data'!$C$154,$W$235,IF($AA235='Menu Data'!$C$155,$W$236,$AA235))))","v":""},null,"Other significant document change that can be implemented within existing resource in place at participating organisations",null,null,null,{"$f":"IF(Z119='Menu Data'!$A$62,X119,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA236=0,\"\",IF($AA236='Menu Data'!$C$19,$W$234,IF($AA236='Menu Data'!$C$154,$W$235,IF($AA236='Menu Data'!$C$155,$W$236,$AA236))))","v":""},null,"Other significant document change that will have additional resource implications for participating organisations",null,null,null,{"$f":"IF(Z120='Menu Data'!$A$62,X120,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA237=0,\"\",IF($AA237='Menu Data'!$C$19,$W$234,IF($AA237='Menu Data'!$C$154,$W$235,IF($AA237='Menu Data'!$C$155,$W$236,$AA237))))","v":""},null,null,null,null,null,{"$f":"IF(Z121='Menu Data'!$A$62,X121,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA238=0,\"\",IF($AA238='Menu Data'!$C$19,$W$234,IF($AA238='Menu Data'!$C$154,$W$235,IF($AA238='Menu Data'!$C$155,$W$236,$AA238))))","v":""},null,null,null,null,null,{"$f":"IF(Z122='Menu Data'!$A$62,X122,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA239=0,\"\",IF($AA239='Menu Data'!$C$19,$W$234,IF($AA239='Menu Data'!$C$154,$W$235,IF($AA239='Menu Data'!$C$155,$W$236,$AA239))))","v":""},null,null,null,null,null,{"$f":"IF(Z123='Menu Data'!$A$62,X123,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA240=0,\"\",IF($AA240='Menu Data'!$C$19,$W$234,IF($AA240='Menu Data'!$C$154,$W$235,IF($AA240='Menu Data'!$C$155,$W$236,$AA240))))","v":""},null,null,null,null,null,{"$f":"IF(Z124='Menu Data'!$A$62,X124,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA241=0,\"\",IF($AA241='Menu Data'!$C$19,$W$234,IF($AA241='Menu Data'!$C$154,$W$235,IF($AA241='Menu Data'!$C$155,$W$236,$AA241))))","v":""},null,null,null,null,null,{"$f":"IF(Z125='Menu Data'!$A$62,X125,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA242=0,\"\",IF($AA242='Menu Data'!$C$19,$W$234,IF($AA242='Menu Data'!$C$154,$W$235,IF($AA242='Menu Data'!$C$155,$W$236,$AA242))))","v":""},null,null,null,null,null,{"$f":"IF(Z126='Menu Data'!$A$62,X126,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA243=0,\"\",IF($AA243='Menu Data'!$C$19,$W$234,IF($AA243='Menu Data'!$C$154,$W$235,IF($AA243='Menu Data'!$C$155,$W$236,$AA243))))","v":""},null,null,null,null,null,{"$f":"IF(Z127='Menu Data'!$A$62,X127,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA244=0,\"\",IF($AA244='Menu Data'!$C$19,$W$234,IF($AA244='Menu Data'!$C$154,$W$235,IF($AA244='Menu Data'!$C$155,$W$236,$AA244))))","v":""},null,null,null,null,null,{"$f":"IF(Z128='Menu Data'!$A$62,X128,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA245=0,\"\",IF($AA245='Menu Data'!$C$19,$W$234,IF($AA245='Menu Data'!$C$154,$W$235,IF($AA245='Menu Data'!$C$155,$W$236,$AA245))))","v":""},null,null,null,null,null,{"$f":"IF(Z129='Menu Data'!$A$62,X129,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA246=0,\"\",IF($AA246='Menu Data'!$C$19,$W$234,IF($AA246='Menu Data'!$C$154,$W$235,IF($AA246='Menu Data'!$C$155,$W$236,$AA246))))","v":""},null,null,null,null,null,{"$f":"IF(Z130='Menu Data'!$A$62,X130,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA247=0,\"\",IF($AA247='Menu Data'!$C$19,$W$234,IF($AA247='Menu Data'!$C$154,$W$235,IF($AA247='Menu Data'!$C$155,$W$236,$AA247))))","v":""},null,null,null,null,null,{"$f":"IF(Z131='Menu Data'!$A$62,X131,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA248=0,\"\",IF($AA248='Menu Data'!$C$19,$W$234,IF($AA248='Menu Data'!$C$154,$W$235,IF($AA248='Menu Data'!$C$155,$W$236,$AA248))))","v":""},null,null,null,null,null,{"$f":"IF(Z132='Menu Data'!$A$62,X132,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA249=0,\"\",IF($AA249='Menu Data'!$C$19,$W$234,IF($AA249='Menu Data'!$C$154,$W$235,IF($AA249='Menu Data'!$C$155,$W$236,$AA249))))","v":""},null,null,null,null,null,{"$f":"IF(Z133='Menu Data'!$A$62,X133,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA250=0,\"\",IF($AA250='Menu Data'!$C$19,$W$234,IF($AA250='Menu Data'!$C$154,$W$235,IF($AA250='Menu Data'!$C$155,$W$236,$AA250))))","v":""},null,null,null,null,null,{"$f":"IF(Z134='Menu Data'!$A$62,X134,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA251=0,\"\",IF($AA251='Menu Data'!$C$19,$W$234,IF($AA251='Menu Data'!$C$154,$W$235,IF($AA251='Menu Data'!$C$155,$W$236,$AA251))))","v":""},null,null,null,null,null,{"$f":"IF(Z135='Menu Data'!$A$62,X135,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA252=0,\"\",IF($AA252='Menu Data'!$C$19,$W$234,IF($AA252='Menu Data'!$C$154,$W$235,IF($AA252='Menu Data'!$C$155,$W$236,$AA252))))","v":""},null,null,null,null,null,{"$f":"IF(Z136='Menu Data'!$A$62,X136,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA253=0,\"\",IF($AA253='Menu Data'!$C$19,$W$234,IF($AA253='Menu Data'!$C$154,$W$235,IF($AA253='Menu Data'!$C$155,$W$236,$AA253))))","v":""},null,null,null,null,null,{"$f":"IF(Z137='Menu Data'!$A$62,X137,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA254=0,\"\",IF($AA254='Menu Data'!$C$19,$W$234,IF($AA254='Menu Data'!$C$154,$W$235,IF($AA254='Menu Data'!$C$155,$W$236,$AA254))))","v":""},null,null,null,null,null,{"$f":"IF(Z138='Menu Data'!$A$62,X138,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA255=0,\"\",IF($AA255='Menu Data'!$C$19,$W$234,IF($AA255='Menu Data'!$C$154,$W$235,IF($AA255='Menu Data'!$C$155,$W$236,$AA255))))","v":""},null,null,null,null,null,{"$f":"IF(Z139='Menu Data'!$A$62,X139,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA256=0,\"\",IF($AA256='Menu Data'!$C$19,$W$234,IF($AA256='Menu Data'!$C$154,$W$235,IF($AA256='Menu Data'!$C$155,$W$236,$AA256))))","v":""},null,null,null,null,null,{"$f":"IF(Z140='Menu Data'!$A$62,X140,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA257=0,\"\",IF($AA257='Menu Data'!$C$19,$W$234,IF($AA257='Menu Data'!$C$154,$W$235,IF($AA257='Menu Data'!$C$155,$W$236,$AA257))))","v":""},null,null,null,null,null,{"$f":"IF(Z141='Menu Data'!$A$62,X141,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA258=0,\"\",IF($AA258='Menu Data'!$C$19,$W$234,IF($AA258='Menu Data'!$C$154,$W$235,IF($AA258='Menu Data'!$C$155,$W$236,$AA258))))","v":""},null,null,null,null,null,{"$f":"IF(Z142='Menu Data'!$A$62,X142,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA259=0,\"\",IF($AA259='Menu Data'!$C$19,$W$234,IF($AA259='Menu Data'!$C$154,$W$235,IF($AA259='Menu Data'!$C$155,$W$236,$AA259))))","v":""},null,null,null,null,null,{"$f":"IF(Z143='Menu Data'!$A$62,X143,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA260=0,\"\",IF($AA260='Menu Data'!$C$19,$W$234,IF($AA260='Menu Data'!$C$154,$W$235,IF($AA260='Menu Data'!$C$155,$W$236,$AA260))))","v":""},null,null,null,null,null,{"$f":"IF(Z144='Menu Data'!$A$62,X144,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA261=0,\"\",IF($AA261='Menu Data'!$C$19,$W$234,IF($AA261='Menu Data'!$C$154,$W$235,IF($AA261='Menu Data'!$C$155,$W$236,$AA261))))","v":""},null,null,null,null,null,{"$f":"IF(Z145='Menu Data'!$A$62,X145,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA262=0,\"\",IF($AA262='Menu Data'!$C$19,$W$234,IF($AA262='Menu Data'!$C$154,$W$235,IF($AA262='Menu Data'!$C$155,$W$236,$AA262))))","v":""},null,null,null,null,null,{"$f":"IF(Z146='Menu Data'!$A$62,X146,0)","v":0}]
[null,null,{"$f":"U263","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA263=0,\"\",IF($AA263='Menu Data'!$C$19,$W$234,IF($AA263='Menu Data'!$C$154,$W$235,IF($AA263='Menu Data'!$C$155,$W$236,$AA263))))","v":""},null,null,null,null,null,{"$f":"IF(Z147='Menu Data'!$A$62,X147,0)","v":0}]
[null,"E.3.8","Other case",null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$R$7","v":0},{"$f":"IF(OR('Amendment Tool'!$AP$613:$AP$622='Menu Data'!$A$63),TRUE,FALSE)","v":false},{"$f":"IF(OR('Amendment Tool'!$AP$613:$AP$622='Menu Data'!$A$63),FALSE,TRUE)","v":true}]
[null,"E.3.8.1","If yes specify:",null,null,null,null,null,null,null,null,null,null,null,null,null,"Populates automatically based on Section 2 of the tool. Edit if required. Adjust the row height if more space is needed.",0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(AND($R$7<>0,S264=TRUE,R267=0),1,0)","v":0}]
[null,null,{"$f":"U267","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(C267<>\"\",1,0)","v":0},null,null,{"$f":"IF(AC198=0,\"\",V267)","v":""},"Change to administrative details for the project - see E.2.3.1 for details",{"$f":"'Menu Data'!$A$2","v":"Administrative details for the project "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W267),1,0)","v":0}]
[null,null,{"$f":"U268","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to administrative details for the project - see E.2.4.1 for details",{"$f":"'Menu Data'!$A$2","v":"Administrative details for the project "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W268),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to confidential patient information arrangements - see E.2.3.1 for details",{"$f":"'Menu Data'!$A$3","v":"Confidential patient information arrangements "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W269),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to confidential patient information arrangements - see E.2.4.1 for details",{"$f":"'Menu Data'!$A$3","v":"Confidential patient information arrangements "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W270),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to CTIMP documents - see E.2.3.1 for details",{"$f":"'Menu Data'!$A$4","v":"CTIMP documents "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W271),1,0)","v":0}]
[null,null,{"$f":"U272","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to CTIMP documents - see E.2.4.1 for details",{"$f":"'Menu Data'!$A$4","v":"CTIMP documents "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W272),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to CTIMP IMP - see E.2.3.1 for details",{"$f":"'Menu Data'!$A$5","v":"CTIMP IMP "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W273),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to CTIMP IMP - see E.2.4.1 for details",{"$f":"'Menu Data'!$A$5","v":"CTIMP IMP "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W274),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to CTIMP safety - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$6","v":"CTIMP safety "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W275),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to CTIMP safety - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$6","v":"CTIMP safety "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W276),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Ionising radiation exposure not involving Radioactive Substances - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$7","v":"Ionising radiation exposure not involving Radioactive Substances "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W277),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Ionising radiation exposure not involving Radioactive Substances - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$7","v":"Ionising radiation exposure not involving Radioactive Substances "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W278),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Medical Devices and related management arrangements - see E.2.3.1 for details",{"$f":"'Menu Data'!$A$8","v":"Medical Devices and related management arrangements "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W279),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Medical Devices and related management arrangements - see E.2.4.1 for details",{"$f":"'Menu Data'!$A$8","v":"Medical Devices and related management arrangements "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W280),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change involving MoDREC - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$9","v":"MoDREC "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W281),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change involving MoDREC - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$9","v":"MoDREC "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W282),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Other change - see E.2.3.1 for details",{"$f":"'Menu Data'!$A$10","v":"Other "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W283),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Other change - see E.2.4.1 for details",{"$f":"'Menu Data'!$A$10","v":"Other "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W284),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Participant Procedures - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$11","v":"Participant Procedures "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W285),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Participant Procedures - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$11","v":"Participant Procedures "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W286),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Participating Organisations - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$12","v":"Participating Organisations "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W287),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to Participating Organisations - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$12","v":"Participating Organisations "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W288),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change involving prisoners - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$13","v":"Prisoners "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W289),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change involving prisoners - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$13","v":"Prisoners "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W290),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change involving Radioactive Substances - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$14","v":"Radioactive Substances "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W291),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change involving Radioactive Substances - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$14","v":"Radioactive Substances "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W292),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to researchers - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$15","v":"Researchers "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W293),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to researchers - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$15","v":"Researchers "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W294),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Stop or restart - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$16","v":"Stop or Restart "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W295),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Stop or restart - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$16","v":"Stop or Restart "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W296),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"IF(C297<>\"\",1,0)","v":0},null,null,"","Change to study design - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$17","v":"Study Design "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W297),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to study design - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$17","v":"Study Design "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W298),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to study documents - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$18","v":"Study Documents "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W299),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to study documents - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$18","v":"Study Documents "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W300),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to study management - see E.2.3.1 for details ",{"$f":"'Menu Data'!$A$19","v":"Study Management "},null,null,null,null,null,{"$f":"IF(COUNTIF($AE$118:$AE$147,W301),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,"","Change to study management - see E.2.4.1 for details ",{"$f":"'Menu Data'!$A$19","v":"Study Management "},null,null,null,null,null,{"$f":"IF(COUNTIF($AF$118:$AF$147,W302),1,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA303=0,\"\",IF($AA303='Menu Data'!$C$19,$W$303,IF($AA303='Menu Data'!$C$154,$W$304,IF($AA303='Menu Data'!$C$155,$W$305,$AA303))))","v":""},null,"Other change",null,null,null,{"$f":"IF(Z118='Menu Data'!$A$63,X118,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA304=0,\"\",IF($AA304='Menu Data'!$C$19,$W$303,IF($AA304='Menu Data'!$C$154,$W$304,IF($AA304='Menu Data'!$C$155,$W$305,$AA304))))","v":""},null,"Other significant document change that can be implemented within existing resource in place at participating organisations",null,null,null,{"$f":"IF(Z119='Menu Data'!$A$63,X119,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA305=0,\"\",IF($AA305='Menu Data'!$C$19,$W$303,IF($AA305='Menu Data'!$C$154,$W$304,IF($AA305='Menu Data'!$C$155,$W$305,$AA305))))","v":""},null,"Other significant document change that will have additional resource implications for participating organisations",null,null,null,{"$f":"IF(Z120='Menu Data'!$A$63,X120,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA306=0,\"\",IF($AA306='Menu Data'!$C$19,$W$303,IF($AA306='Menu Data'!$C$154,$W$304,IF($AA306='Menu Data'!$C$155,$W$305,$AA306))))","v":""},null,null,null,null,null,{"$f":"IF(Z121='Menu Data'!$A$63,X121,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA307=0,\"\",IF($AA307='Menu Data'!$C$19,$W$303,IF($AA307='Menu Data'!$C$154,$W$304,IF($AA307='Menu Data'!$C$155,$W$305,$AA307))))","v":""},null,null,null,null,null,{"$f":"IF(Z122='Menu Data'!$A$63,X122,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA308=0,\"\",IF($AA308='Menu Data'!$C$19,$W$303,IF($AA308='Menu Data'!$C$154,$W$304,IF($AA308='Menu Data'!$C$155,$W$305,$AA308))))","v":""},null,null,null,null,null,{"$f":"IF(Z123='Menu Data'!$A$63,X123,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA309=0,\"\",IF($AA309='Menu Data'!$C$19,$W$303,IF($AA309='Menu Data'!$C$154,$W$304,IF($AA309='Menu Data'!$C$155,$W$305,$AA309))))","v":""},null,null,null,null,null,{"$f":"IF(Z124='Menu Data'!$A$63,X124,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA310=0,\"\",IF($AA310='Menu Data'!$C$19,$W$303,IF($AA310='Menu Data'!$C$154,$W$304,IF($AA310='Menu Data'!$C$155,$W$305,$AA310))))","v":""},null,null,null,null,null,{"$f":"IF(Z125='Menu Data'!$A$63,X125,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA311=0,\"\",IF($AA311='Menu Data'!$C$19,$W$303,IF($AA311='Menu Data'!$C$154,$W$304,IF($AA311='Menu Data'!$C$155,$W$305,$AA311))))","v":""},null,null,null,null,null,{"$f":"IF(Z126='Menu Data'!$A$63,X126,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA312=0,\"\",IF($AA312='Menu Data'!$C$19,$W$303,IF($AA312='Menu Data'!$C$154,$W$304,IF($AA312='Menu Data'!$C$155,$W$305,$AA312))))","v":""},null,null,null,null,null,{"$f":"IF(Z127='Menu Data'!$A$63,X127,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA313=0,\"\",IF($AA313='Menu Data'!$C$19,$W$303,IF($AA313='Menu Data'!$C$154,$W$304,IF($AA313='Menu Data'!$C$155,$W$305,$AA313))))","v":""},null,null,null,null,null,{"$f":"IF(Z128='Menu Data'!$A$63,X128,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA314=0,\"\",IF($AA314='Menu Data'!$C$19,$W$303,IF($AA314='Menu Data'!$C$154,$W$304,IF($AA314='Menu Data'!$C$155,$W$305,$AA314))))","v":""},null,null,null,null,null,{"$f":"IF(Z129='Menu Data'!$A$63,X129,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA315=0,\"\",IF($AA315='Menu Data'!$C$19,$W$303,IF($AA315='Menu Data'!$C$154,$W$304,IF($AA315='Menu Data'!$C$155,$W$305,$AA315))))","v":""},null,null,null,null,null,{"$f":"IF(Z130='Menu Data'!$A$63,X130,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA316=0,\"\",IF($AA316='Menu Data'!$C$19,$W$303,IF($AA316='Menu Data'!$C$154,$W$304,IF($AA316='Menu Data'!$C$155,$W$305,$AA316))))","v":""},null,null,null,null,null,{"$f":"IF(Z131='Menu Data'!$A$63,X131,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA317=0,\"\",IF($AA317='Menu Data'!$C$19,$W$303,IF($AA317='Menu Data'!$C$154,$W$304,IF($AA317='Menu Data'!$C$155,$W$305,$AA317))))","v":""},null,null,null,null,null,{"$f":"IF(Z132='Menu Data'!$A$63,X132,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA318=0,\"\",IF($AA318='Menu Data'!$C$19,$W$303,IF($AA318='Menu Data'!$C$154,$W$304,IF($AA318='Menu Data'!$C$155,$W$305,$AA318))))","v":""},null,null,null,null,null,{"$f":"IF(Z133='Menu Data'!$A$63,X133,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA319=0,\"\",IF($AA319='Menu Data'!$C$19,$W$303,IF($AA319='Menu Data'!$C$154,$W$304,IF($AA319='Menu Data'!$C$155,$W$305,$AA319))))","v":""},null,null,null,null,null,{"$f":"IF(Z134='Menu Data'!$A$63,X134,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA320=0,\"\",IF($AA320='Menu Data'!$C$19,$W$303,IF($AA320='Menu Data'!$C$154,$W$304,IF($AA320='Menu Data'!$C$155,$W$305,$AA320))))","v":""},null,null,null,null,null,{"$f":"IF(Z135='Menu Data'!$A$63,X135,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA321=0,\"\",IF($AA321='Menu Data'!$C$19,$W$303,IF($AA321='Menu Data'!$C$154,$W$304,IF($AA321='Menu Data'!$C$155,$W$305,$AA321))))","v":""},null,null,null,null,null,{"$f":"IF(Z136='Menu Data'!$A$63,X136,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA322=0,\"\",IF($AA322='Menu Data'!$C$19,$W$303,IF($AA322='Menu Data'!$C$154,$W$304,IF($AA322='Menu Data'!$C$155,$W$305,$AA322))))","v":""},null,null,null,null,null,{"$f":"IF(Z137='Menu Data'!$A$63,X137,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA323=0,\"\",IF($AA323='Menu Data'!$C$19,$W$303,IF($AA323='Menu Data'!$C$154,$W$304,IF($AA323='Menu Data'!$C$155,$W$305,$AA323))))","v":""},null,null,null,null,null,{"$f":"IF(Z138='Menu Data'!$A$63,X138,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA324=0,\"\",IF($AA324='Menu Data'!$C$19,$W$303,IF($AA324='Menu Data'!$C$154,$W$304,IF($AA324='Menu Data'!$C$155,$W$305,$AA324))))","v":""},null,null,null,null,null,{"$f":"IF(Z139='Menu Data'!$A$63,X139,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA325=0,\"\",IF($AA325='Menu Data'!$C$19,$W$303,IF($AA325='Menu Data'!$C$154,$W$304,IF($AA325='Menu Data'!$C$155,$W$305,$AA325))))","v":""},null,null,null,null,null,{"$f":"IF(Z140='Menu Data'!$A$63,X140,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA326=0,\"\",IF($AA326='Menu Data'!$C$19,$W$303,IF($AA326='Menu Data'!$C$154,$W$304,IF($AA326='Menu Data'!$C$155,$W$305,$AA326))))","v":""},null,null,null,null,null,{"$f":"IF(Z141='Menu Data'!$A$63,X141,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA327=0,\"\",IF($AA327='Menu Data'!$C$19,$W$303,IF($AA327='Menu Data'!$C$154,$W$304,IF($AA327='Menu Data'!$C$155,$W$305,$AA327))))","v":""},null,null,null,null,null,{"$f":"IF(Z142='Menu Data'!$A$63,X142,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA328=0,\"\",IF($AA328='Menu Data'!$C$19,$W$303,IF($AA328='Menu Data'!$C$154,$W$304,IF($AA328='Menu Data'!$C$155,$W$305,$AA328))))","v":""},null,null,null,null,null,{"$f":"IF(Z143='Menu Data'!$A$63,X143,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA329=0,\"\",IF($AA329='Menu Data'!$C$19,$W$303,IF($AA329='Menu Data'!$C$154,$W$304,IF($AA329='Menu Data'!$C$155,$W$305,$AA329))))","v":""},null,null,null,null,null,{"$f":"IF(Z144='Menu Data'!$A$63,X144,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA330=0,\"\",IF($AA330='Menu Data'!$C$19,$W$303,IF($AA330='Menu Data'!$C$154,$W$304,IF($AA330='Menu Data'!$C$155,$W$305,$AA330))))","v":""},null,null,null,null,null,{"$f":"IF(Z145='Menu Data'!$A$63,X145,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA331=0,\"\",IF($AA331='Menu Data'!$C$19,$W$303,IF($AA331='Menu Data'!$C$154,$W$304,IF($AA331='Menu Data'!$C$155,$W$305,$AA331))))","v":""},null,null,null,null,null,{"$f":"IF(Z146='Menu Data'!$A$63,X146,0)","v":0}]
[null,null,"",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0,null,null,{"$f":"IF($AA332=0,\"\",IF($AA332='Menu Data'!$C$19,$W$303,IF($AA332='Menu Data'!$C$154,$W$304,IF($AA332='Menu Data'!$C$155,$W$305,$AA332))))","v":""},null,null,null,null,null,{"$f":"IF(Z147='Menu Data'!$A$63,X147,0)","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$R$7","v":0}]
[null,"E.4","Information on temporary halt of trial8",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"E.4.1","Date of temporary halt",null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter date if applicable, it will default to YYYY/MM/DD format.",0]
[null,"E.4.2","Recruitment has been stopped",null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick as applicable.",0]
[null,"E.4.3","Treatment has been stopped",null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick as applicable.",0]
[null,"E.4.4","Number of patients still receiving treatment at time of the temporary halt in the MS concerned",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"by the amendment",null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter number if applicable.",0]
[null,"E.4.5","Briefly describe (free text):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"•","Justification for a temporary halt of the trial",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"•","The proposed management of patients receiving treatment at time of the halt (free text).",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"•","The consequences of the temporary halt for the evaluation of the results and for overall risk benefit assessment of the investigational medicinal product (free text).",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,{"$f":"U344","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,"Populates automatically based on any free text entered for a temporary halt of study in Section 2 of the tool. Edit if required. Adjust the row height if more space is needed.",0,null,null,{"$f":"IF('Amendment Tool'!$M$102='Menu Data'!$C$120,'Amendment Tool'!$M$103,IF('Amendment Tool'!$M$151='Menu Data'!$C$120,'Amendment Tool'!$M$152,IF('Amendment Tool'!$M$200='Menu Data'!$C$120,'Amendment Tool'!$M$201,IF('Amendment Tool'!$M$249='Menu Data'!$C$120,'Amendment Tool'!$M$250,IF('Amendment Tool'!$M$298='Menu Data'!$C$120,'Amendment Tool'!$M$299,IF('Amendment Tool'!$M$347='Menu Data'!$C$120,'Amendment Tool'!$M$348,IF('Amendment Tool'!$M$396='Menu Data'!$C$120,'Amendment Tool'!$M$397,IF('Amendment Tool'!$M$445='Menu Data'!$C$120,'Amendment Tool'!$M$446,IF('Amendment Tool'!$M$494='Menu Data'!$C$120,'Amendment Tool'!$M$495,IF('Amendment Tool'!$M$543='Menu Data'!$C$120,'Amendment Tool'!$M$544,\"\"))))))))))","v":""}]
[null,"(8) Cf. Section 3.10. of the detailed guidance CT-1.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"F","DESCRIPTION OF EACH SUBSTANTIAL AMENDMENT9 (free text):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"Previous and new wording in track change modus",null,null,null,"New wording",null,null,null,"Comments/explanations/reasons for substantial amendment",null,null,null,null,null,null,"Consider submitting this documentation on a separate sheet as suggested in footnote 9 that applies to section F of the Annex 2 form.",0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",{"$f":"IF(AND(R349=1,S349=TRUE),1,0)","v":0},false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",{"$f":"IF(AND(R350=1,S350=TRUE),1,0)","v":0},false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",{"$f":"IF(AND(R351=1,S351=TRUE),1,0)","v":0},false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick this box to add a new row. Adjust the row height if more space is needed.",0,false]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Adjust the row height if more space is needed.",0]
[null,"(9) Cf. Section 3.7.c. of the detailed guidance CT-1. The sponsor may submit this documentation on a separate sheet.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G","CHANGE OF CLINICAL TRIAL SITE(S)/INVESTIGATOR(S) IN THE MEMBER STATE CONCERNED BY THIS AMENDMENT",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1","Type of change",null,null,null,null,null,null,null,null,null,null,null,null,null,"Add details as required.",0]
[null,"G.1.1","Addition of a new site",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.1.1","Principal investigator (provide details below)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.1.1.1","Given name",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.1.1.2","Middle name (if applicable)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.1.1.3","Family name",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.1.1.4","Qualifications (MD……..)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.1.1.5","Professional address",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.2","Removal of an existing site",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.2.1","Principal investigator (provide details below)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.2.1.1","Given name",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.2.1.2","Middle name (if applicable)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.2.1.3","Family name",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.2.1.4","Qualifications (MD……..)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.2.1.5","Professional address",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.3","Change of co-ordinating investigator (provide details below of the new coordinating investigator)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.3.1","Given name",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.3.2","Middle name",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.3.3","Family name",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.3.4","Qualifications (MD……..)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.3.5","Professional address",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.3.6","Indicate the name of the previous co-ordinating investigator:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.4","Change of principal investigator at an existing site (provide details below of the new principal investigator)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.4.1","Given name",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.4.2","Middle name",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.4.3","Family name",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.4.4","Qualifications (MD……..)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.4.5","Professional address",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"G.1.4.6","Indicate the name of the previous co-ordinating investigator:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"H","CHANGE OF INSTRUCTIONS TO CA FOR FEEDBACK TO SPONSOR",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"H.1","Change of e-mail contact for feedback on application*",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"H.2","Change to request to receive an .xml copy of CTA data",null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick as applicable.",0]
[null,"H.2.1","Do you want a .xml file copy of the CTA form saved on EudraCT?",null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick as applicable.",0,false]
[null,"H.2.1.1","If yes provide the e-mail address(es) to which it should be sent (up to 5 addresses):",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter as required. Must be a valid email address format.",{"$f":"IF($R$5=1,0,IF($S$406=FALSE,0,$R$7))","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$R$408","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$R$408","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"H.2.2","Do you want to receive this via password protected link(s)10?",null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick as applicable.",{"$f":"$R$7","v":0}]
[null,"If you answer no to question H.2.2 the .xml file will be transmitted by less secure e-mail link(s)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"H.2.3","Do you want to stop messages to an email for which they were previously requested?",null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick as applicable.",0,false]
[null,"H.2.3.1","If yes provide the e-mail address(es) to which feedback should no longer be sent:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Enter as required. Must be a valid email address format.",{"$f":"IF($R$5=1,0,IF($S$415=FALSE,0,$R$7))","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$R$417","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$R$417","v":0}]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"(*This will only come into effect from the time at which the request is processed in EudraCT).",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"$R$7","v":0}]
[null,"(10) This requires a EudraLink account. (See https://eudract.ema.europa.eu/ for details)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"I","LIST OF THE DOCUMENTS APPENDED TO THE NOTIFICATION FORM (cf. Section 3.7 of detailed guidance CT-1)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,"Please submit only relevant documents and/or when applicable make clear references to the new ones already submitted. Make clear references to any changes of separate pages and submit old and new texts. Tick the appropriate box(es).",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"I.1","Cover letter",null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick as applicable.",0]
[null,"I.2","Extract from the amended document in accordance with Section 3.7.c. of detailed guidance\nCT-1 (if not contained in Part F of this form)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"I.3","Entire new version of the document11",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"I.4","Supporting information",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"I.5","Revised .xml file and copy of initial application form with amended data highlighted",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"I.6","Comments on any novel aspect of the amendment if any:",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Adjust the row height if more space is needed.",0]
[null,"(11) Cf. Section 3.7.c. of the detailed guidance CT-1.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"J","SIGNATURE OF THE APPLICANT IN THE MEMBER STATE",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"J.1","I hereby confirm that/confirm on behalf of the sponsor that (delete which is not applicable)",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"•","The above information given on this request is correct;",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"•","The trial will be conducted according to the protocol, national regulation and the principles of good clinical practice; and",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"•","It is reasonable for the proposed amendment to be undertaken.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"J.2","APPLICANT OF THE REQUEST FOR THE COMPETENT AUTHORITY\n(as stated in section D.1):",null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick box will automatically select based on A.2",0,{"$f":"$S$22","v":false}]
[null,"J.2.1","Signature12:",null,null,null,null,null,null,null,null,null,null,null,null,null,"To insert an image of a signature, right click the signature field: Change Picture > From a File, then select the file containing the signature image.",0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"Per the MHRA guidance, the CESP User ID can be entered in the signature field. Enter it here if using.",0]
[null,"J.2.2","Print name:",null,{"$f":"U446","v":""},null,null,null,null,null,null,null,null,null,null,null,"Copies the name based on the answer to D.1. Edit if required.",0,null,null,{"$f":"IF($S$443=FALSE,\"\",$V$446)","v":""},{"$f":"IF($S$81=TRUE,$F$64,IF($S$82=TRUE,$F$72,IF($S$83=TRUE,$F$86,\"\")))","v":""}]
[null,"J.2.3","Date:",null,{"$f":"U447","v":""},null,null,null,null,null,null,null,null,null,null,null,"Automatically uses today's date. Edit if required.",0,null,null,{"$f":"IF($S$443=TRUE,TODAY(),\"\")","v":""}]
[null,"(12) On an application to the Competent Authority only, the applicant to the Competent Authority needs to sign.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"J.3","APPLICANT OF THE REQUEST FOR THE ETHICS COMMITTEE\n(as stated in section D.2):",null,null,null,null,null,null,null,null,null,null,null,null,null,"Tick box will automatically select based on A.3",0,{"$f":"$S$23","v":true}]
[null,"J.3.1","Signature13:",null,null,null,null,null,null,null,null,null,null,null,null,null,"To insert an image of a signature, right click the signature field: Change Picture > From a File, then select the file containing the signature image.",0]
[null,"J.3.2","Print name:",null,{"$f":"U452","v":""},null,null,null,null,null,null,null,null,null,null,null,"Copies the name based on the answer to D.2. Edit if required.",0,null,null,{"$f":"IF($S$450=FALSE,\"\",$V$452)","v":""},{"$f":"IF($S$93=TRUE,$F$64,IF($S$94=TRUE,$F$72,IF((OR($S$95=TRUE,$S$97=TRUE,$S$98=TRUE)),$F$101,\"\")))","v":""}]
[null,"J.3.3","Date:",null,{"$f":"U453","v":"2021-03-23"},null,null,null,null,null,null,null,null,null,null,null,"Automatically uses today's date. Edit if required.",0,null,null,{"$f":"IF($S$450=TRUE,TODAY(),\"\")","v":"2021-03-23"}]
[null,"(13) On an application to the Ethics Committee only, the applicant to the Ethics Committee needs to sign.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"Lock for submission",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,"Please note: This button will only become available when all mandatory (*) fields have been completed on the \"Amendment Tool\" tab. When the button is available, clicking it will generate a PDF copy of the Annex 2 form that can be included in the amendment submission. Please ensure that the Annex 2 form is contains all of the intended information before locking it for submission.",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,0]
[null,null,null,null,"Lock for submission",null,null,null,null,null,null,null,null,null,null,null,null,0,{"$f":"'Amendment Tool'!$AN$598","v":1}]
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["Administrative details for the project ",null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"COUNTIF($Z$3:$Z$8,1)","v":6},null,"Administrative_details_for_the_project_5/6"]
["Confidential patient information arrangements ",{"$f":"LEN(C3)","v":43},"Contact details - CI or other project staff",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$30","v":"Y"},{"$f":"$A$30","v":"Y"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},"N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$40","v":"C"},{"$f":"$A$46","v":"E.2.1"},{"$f":"$A$62","v":"E.3.7"},{"$f":"$A$85","v":"N/A"},1,{"$f":"IF($Z3>0,$C3,0)","v":"Contact details - CI or other project staff"},{"$f":"INDEX($AA$3:$AA$8,SMALL(IF(ISTEXT($AA$3:$AA$8),ROW($AA$1:$AA$6),\"\"),ROW(A1)))","v":"Contact details - CI or other project staff"}]
["CTIMP documents ",{"$f":"LEN(C4)","v":24},"Contact details - Funder",{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},"N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$40","v":"C"},{"$f":"$A$53","v":"N/A"},{"$f":"$A$64","v":"N/A"},{"$f":"$A$85","v":"N/A"},1,{"$f":"IF($Z4>0,$C4,0)","v":"Contact details - Funder"},{"$f":"INDEX($AA$3:$AA$8,SMALL(IF(ISTEXT($AA$3:$AA$8),ROW($AA$1:$AA$6),\"\"),ROW(A2)))","v":"Contact details - Funder"}]
["CTIMP IMP ",58,"Contact details - Insurer (insurance arrangements ongoing)",{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},"N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$40","v":"C"},{"$f":"$A$53","v":"N/A"},{"$f":"$A$64","v":"N/A"},{"$f":"$A$85","v":"N/A"},1,{"$f":"IF($Z5>0,$C5,0)","v":"Contact details - Insurer (insurance arrangements ongoing)"},{"$f":"INDEX($AA$3:$AA$8,SMALL(IF(ISTEXT($AA$3:$AA$8),ROW($AA$1:$AA$6),\"\"),ROW(A3)))","v":"Contact details - Insurer (insurance arrangements ongoing)"}]
["CTIMP safety ",43,"Contact details - Sponsor or representative",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$30","v":"Y"},{"$f":"$A$30","v":"Y"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},"N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$40","v":"C"},{"$f":"$A$46","v":"E.2.1"},{"$f":"$A$62","v":"E.3.7"},{"$f":"$A$85","v":"N/A"},{"$f":"IF(AND('Amendment Tool'!AE61=1,'Amendment Tool'!AF60=1),0,1)","v":1},{"$f":"IF($Z6>0,$C6,0)","v":"Contact details - Sponsor or representative"},{"$f":"INDEX($AA$3:$AA$8,SMALL(IF(ISTEXT($AA$3:$AA$8),ROW($AA$1:$AA$6),\"\"),ROW(A4)))","v":"Contact details - Sponsor or representative"}]
["Ionising radiation exposure not involving Radioactive Substances ",67,"Other administrative change - Please specify in the free text below",{"$f":"$A$32","v":"N"},"N",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},"N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$40","v":"C"},{"$f":"$A$53","v":"N/A"},{"$f":"$A$64","v":"N/A"},{"$f":"$A$85","v":"N/A"},1,{"$f":"IF($Z7>0,$C7,0)","v":"Other administrative change - Please specify in the free text below"},{"$f":"INDEX($AA$3:$AA$8,SMALL(IF(ISTEXT($AA$3:$AA$8),ROW($AA$1:$AA$6),\"\"),ROW(A5)))","v":"Other administrative change - Please specify in the free text below"}]
["Medical Devices and related management arrangements ",64,"Project identification (e.g. change of title, reference numbers)",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},"N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$40","v":"C"},{"$f":"$A$53","v":"N/A"},{"$f":"$A$64","v":"N/A"},{"$f":"$A$85","v":"N/A"},1,{"$f":"IF($Z8>0,$C8,0)","v":"Project identification (e.g. change of title, reference numbers)"},{"$f":"INDEX($AA$3:$AA$8,SMALL(IF(ISTEXT($AA$3:$AA$8),ROW($AA$1:$AA$6),\"\"),ROW(A6)))","v":"Project identification (e.g. change of title, reference numbers)"}]
["MoDREC ",0]
["Other ",50,"Confidential_patient_information_arrangements_Full",{"$f":"$D$1","v":"REC/MoDREC"},{"$f":"$E$1","v":"MHRA Meds"},{"$f":"$F$1","v":"MHRA Devs"},{"$f":"$G$1","v":"ARSAC"},{"$f":"$H$1","v":"Radiation"},{"$f":"$I$1","v":"UKSW"},{"$f":"$J$1","v":"REC (MCA)"},{"$f":"$K$1","v":"CAG"},{"$f":"$L$1","v":"HMPPS"},{"$f":"$M$1","v":"HRA HCRW"},{"$f":"$N$1","v":"REC (AWIA)"},{"$f":"$O$1","v":"PBPP"},{"$f":"$P$1","v":"SPS (RAEC)"},{"$f":"$Q$1","v":"NHS P"},{"$f":"$R$1","v":"HSC REC"},{"$f":"$S$1","v":"HSC DG"},{"$f":"$T$1","v":"Prisons"},{"$f":"$U$1","v":"HSC P"},{"$f":"$V$1","v":"Category"},{"$f":"$W$1","v":"Annex 2 Type"},{"$f":"$X$1","v":"Annex 2 Reason"},{"$f":"$Y$1","v":"CWoW"},{"$f":"$Z$1","v":"Applicability"}]
["Participant Procedures ",0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"COUNTIF($Z$12:$Z$20,1)","v":9},null,"Confidential_patient_information_arrangements_9"]
["Participating Organisations ",82,"Confidential patient information being accessed without consent for the first time",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},"N",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},"N",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},"N",{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$49","v":"E.2.4"},{"$f":"$A$62","v":"E.3.7"},{"$f":"$A$87","v":"Part 2"},1,{"$f":"IF($Z12>0,$C12,0)","v":"Confidential patient information being accessed without consent for the first time"},{"$f":"INDEX($AA$12:$AA$20,SMALL(IF(ISTEXT($AA$12:$AA$20),ROW($AA$1:$AA$9),\"\"),ROW(A1)))","v":"Confidential patient information being accessed without consent for the first time"}]
["Prisoners ",15,"Data controller","Y","N","Y","N","N","Y","N","Y","N","Y","N","Y","N","Y","N","Y","N","Y","V","E.2.4","E.3.7","Part 2",1,"Data controller",{"$f":"INDEX($AA$12:$AA$20,SMALL(IF(ISTEXT($AA$12:$AA$20),ROW($AA$1:$AA$9),\"\"),ROW(A2)))","v":"Data controller"}]
["Radioactive Substances ",10,"Data flows","Y","N","Y","N","N","Y","N","Y","N","Y","N","Y","N","Y","N","Y","N","Y","V","E.2.4","E.3.7","Part 2",1,"Data flows",{"$f":"INDEX($AA$12:$AA$20,SMALL(IF(ISTEXT($AA$12:$AA$20),ROW($AA$1:$AA$9),\"\"),ROW(A3)))","v":"Data flows"}]
["Researchers ",10,"Data items","Y","N","Y","N","N","Y","N","Y","N","Y","N","Y","N","Y","N","Y","N","Y","V","E.2.4","E.3.7","Part 2",1,"Data items",{"$f":"INDEX($AA$12:$AA$20,SMALL(IF(ISTEXT($AA$12:$AA$20),ROW($AA$1:$AA$9),\"\"),ROW(A4)))","v":"Data items"}]
["Stop or Restart ",14,"Data processor","Y","N","Y","N","N","Y","N","Y","N","Y","N","Y","N","Y","N","Y","N","Y","V","E.2.4","E.3.7","Part 2",1,"Data processor",{"$f":"INDEX($AA$12:$AA$20,SMALL(IF(ISTEXT($AA$12:$AA$20),ROW($AA$1:$AA$9),\"\"),ROW(A5)))","v":"Data processor"}]
["Study Design ",12,"Data sources","Y","N","Y","N","N","Y","N","Y","N","Y","N","Y","N","Y","N","Y","N","Y","V","E.2.4","E.3.7","Part 2",1,"Data sources",{"$f":"INDEX($AA$12:$AA$20,SMALL(IF(ISTEXT($AA$12:$AA$20),ROW($AA$1:$AA$9),\"\"),ROW(A6)))","v":"Data sources"}]
["Study Documents ",8,"Duration","Y","N","Y","N","N",{"$f":"$A$31","v":"(Y)"},"N","Y","N",{"$f":"$A$31","v":"(Y)"},"N","Y","N",{"$f":"$A$31","v":"(Y)"},"N","Y","N",{"$f":"$A$31","v":"(Y)"},"V","E.2.4","E.3.7","Part 2",1,"Duration",{"$f":"INDEX($AA$12:$AA$20,SMALL(IF(ISTEXT($AA$12:$AA$20),ROW($AA$1:$AA$9),\"\"),ROW(A7)))","v":"Duration"}]
["Study Management ",45,"Other - Please specify in the free text below","Y","N","Y","N","N",{"$f":"$A$30","v":"Y"},"N","Y","N",{"$f":"$A$30","v":"Y"},"N","Y","N",{"$f":"$A$30","v":"Y"},"N","Y","N",{"$f":"$A$30","v":"Y"},"V","E.2.4","E.3.7","Part 2",1,"Other - Please specify in the free text below",{"$f":"INDEX($AA$12:$AA$20,SMALL(IF(ISTEXT($AA$12:$AA$20),ROW($AA$1:$AA$9),\"\"),ROW(A8)))","v":"Other - Please specify in the free text below"}]
[null,23,"Purposes of application","Y","N","Y","N","N",{"$f":"$A$30","v":"Y"},"N","Y","N",{"$f":"$A$30","v":"Y"},"N","Y","N",{"$f":"$A$30","v":"Y"},"N","Y","N",{"$f":"$A$30","v":"Y"},"V","E.2.4","E.3.7","Part 2",1,"Purposes of application",{"$f":"INDEX($AA$12:$AA$20,SMALL(IF(ISTEXT($AA$12:$AA$20),ROW($AA$1:$AA$9),\"\"),ROW(A9)))","v":"Purposes of application"}]
["Type",0]
["Substantial for review",14,"CTIMP_IMP_Full",{"$f":"$D$1","v":"REC/MoDREC"},{"$f":"$E$1","v":"MHRA Meds"},{"$f":"$F$1","v":"MHRA Devs"},{"$f":"$G$1","v":"ARSAC"},{"$f":"$H$1","v":"Radiation"},{"$f":"$I$1","v":"UKSW"},{"$f":"$J$1","v":"REC (MCA)"},{"$f":"$K$1","v":"CAG"},{"$f":"$L$1","v":"HMPPS"},{"$f":"$M$1","v":"HRA HCRW"},{"$f":"$N$1","v":"REC (AWIA)"},{"$f":"$O$1","v":"PBPP"},{"$f":"$P$1","v":"SPS (RAEC)"},{"$f":"$Q$1","v":"NHS P"},{"$f":"$R$1","v":"HSC REC"},{"$f":"$S$1","v":"HSC DG"},{"$f":"$T$1","v":"Prisons"},{"$f":"$U$1","v":"HSC P"},{"$f":"$V$1","v":"Category"},{"$f":"$W$1","v":"Annex 2 Type"},{"$f":"$X$1","v":"Annex 2 Reason"},{"$f":"$Y$1","v":"CWoW"},{"$f":"$Z$1","v":"Applicability"}]
["Substantial for information",0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"COUNTIF($Z$24:$Z$29,1)","v":6},null,"CTIMP_IMP_6"]
["Substantial New Site/PI only",16,"Change of dosing",{"$f":"$A$30","v":"Y"},"Y","Y",{"$f":"$A$32","v":"N"},"N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$43","v":"V"},{"$f":"$A$47","v":"E.2.2"},{"$f":"$A$59","v":"E.3.4"},{"$f":"$A$86","v":"Part 1"},1,{"$f":"IF($Z24>0,$C24,0)","v":"Change of dosing"},{"$f":"INDEX($AA$24:$AA$29,SMALL(IF(ISTEXT($AA$24:$AA$29),ROW($AA$1:$AA$6),\"\"),ROW(A1)))","v":"Change of dosing"}]
["Non-substantial",14,"Change of IMPs",{"$f":"$A$30","v":"Y"},"Y","Y",{"$f":"$A$32","v":"N"},"N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$43","v":"V"},{"$f":"$A$49","v":"E.2.4"},{"$f":"$A$58","v":"E.3.3"},{"$f":"$A$86","v":"Part 1"},1,"Change of IMPs",{"$f":"INDEX($AA$24:$AA$29,SMALL(IF(ISTEXT($AA$24:$AA$29),ROW($AA$1:$AA$6),\"\"),ROW(A2)))","v":"Change of IMPs"}]
["Non-substantial, no study-wide review required",32,"Change of mode of administration","Y","Y","Y","N","N",{"$f":"$A$31","v":"(Y)"},"N","N","N",{"$f":"$A$31","v":"(Y)"},"N","N","N",{"$f":"$A$31","v":"(Y)"},"N","N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$43","v":"V"},{"$f":"$A$47","v":"E.2.2"},{"$f":"$A$59","v":"E.3.4"},{"$f":"$A$86","v":"Part 1"},1,"Change of mode of administration",{"$f":"INDEX($AA$24:$AA$29,SMALL(IF(ISTEXT($AA$24:$AA$29),ROW($AA$1:$AA$6),\"\"),ROW(A3)))","v":"Change of mode of administration"}]
["Non-notifiable",47,"IMP being added to the study for the first time","Y","Y","Y","N","N",{"$f":"$A$30","v":"Y"},"N","N","N",{"$f":"$A$30","v":"Y"},"N","N","N",{"$f":"$A$30","v":"Y"},"N","N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$47","v":"E.2.2"},{"$f":"$A$59","v":"E.3.4"},{"$f":"$A$86","v":"Part 1"},1,"IMP being added to the study for the first time",{"$f":"INDEX($AA$24:$AA$29,SMALL(IF(ISTEXT($AA$24:$AA$29),ROW($AA$1:$AA$6),\"\"),ROW(A4)))","v":"IMP being added to the study for the first time"}]
[null,45,"Other - Please specify in the free text below","Y","Y","Y","N","N",{"$f":"$A$30","v":"Y"},"N","N","N",{"$f":"$A$30","v":"Y"},"N","N","N",{"$f":"$A$30","v":"Y"},"N","N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$49","v":"E.2.4"},{"$f":"$A$62","v":"E.3.7"},{"$f":"$A$86","v":"Part 1"},1,"Other - Please specify in the free text below",{"$f":"INDEX($AA$24:$AA$29,SMALL(IF(ISTEXT($AA$24:$AA$29),ROW($AA$1:$AA$6),\"\"),ROW(A5)))","v":"Other - Please specify in the free text below"}]
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["A",45,"Other - Please specify in the free text below","Y","Y","Y","N","N",{"$f":"$A$30","v":"Y"},"N","N","N",{"$f":"$A$30","v":"Y"},"N","N","N",{"$f":"$A$30","v":"Y"},"N","N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$49","v":"E.2.4"},{"$f":"$A$62","v":"E.3.7"},{"$f":"$A$86","v":"Part 1"},1,"Other - Please specify in the free text below",{"$f":"INDEX($AA$33:$AA$41,SMALL(IF(ISTEXT($AA$33:$AA$41),ROW($AA$1:$AA$9),\"\"),ROW(A5)))","v":"Other - Please specify in the free text below"}]
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["C",86,"Study oversight - Reduction in the sponsor’s planned level of monitoring for the study",{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$30","v":"Y"},"N","N",{"$f":"$A$31","v":"(Y)"},"N","N","N",{"$f":"$A$31","v":"(Y)"},"N","N","N",{"$f":"$A$31","v":"(Y)"},"N","N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$43","v":"V"},{"$f":"$A$49","v":"E.2.4"},{"$f":"$A$59","v":"E.3.4"},{"$f":"$A$86","v":"Part 1"},1,"Study oversight - Reduction in the sponsor’s planned level of monitoring for the study",{"$f":"INDEX($AA$33:$AA$41,SMALL(IF(ISTEXT($AA$33:$AA$41),ROW($AA$1:$AA$9),\"\"),ROW(A8)))","v":"Study oversight - Reduction in the sponsor’s planned level of monitoring for the study"}]
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["N/A",0]
["V",69,"Ionising_radiation_exposure_not_involving_Radioactive_Substances_Full",{"$f":"$D$1","v":"REC/MoDREC"},{"$f":"$E$1","v":"MHRA Meds"},{"$f":"$F$1","v":"MHRA Devs"},{"$f":"$G$1","v":"ARSAC"},{"$f":"$H$1","v":"Radiation"},{"$f":"$I$1","v":"UKSW"},{"$f":"$J$1","v":"REC (MCA)"},{"$f":"$K$1","v":"CAG"},{"$f":"$L$1","v":"HMPPS"},{"$f":"$M$1","v":"HRA HCRW"},{"$f":"$N$1","v":"REC (AWIA)"},{"$f":"$O$1","v":"PBPP"},{"$f":"$P$1","v":"SPS (RAEC)"},{"$f":"$Q$1","v":"NHS P"},{"$f":"$R$1","v":"HSC REC"},{"$f":"$S$1","v":"HSC DG"},{"$f":"$T$1","v":"Prisons"},{"$f":"$U$1","v":"HSC P"},{"$f":"$V$1","v":"Category"},{"$f":"$W$1","v":"Annex 2 Type"},{"$f":"$X$1","v":"Annex 2 Reason"},{"$f":"$Y$1","v":"CWoW"},{"$f":"$Z$1","v":"Applicability"}]
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["E.2.3",86,"Changes to the number of research exposures for previously declared research exposures","Y","N","Y","N","Y","Y","N","N","N","Y","N","N","N","Y","N","N","N","Y","V",{"$f":"$A$47","v":"E.2.2"},{"$f":"$A$59","v":"E.3.4"},{"$f":"$A$86","v":"Part 1"},1,"Changes to the number of research exposures for previously declared research exposures",{"$f":"INDEX($AA$45:$AA$50,SMALL(IF(ISTEXT($AA$45:$AA$50),ROW($AA$1:$AA$6),\"\"),ROW(A4)))","v":"Changes to the number of research exposures for previously declared research exposures"}]
["E.2.4",45,"Other - Please specify in the free text below","Y","N","Y","N","Y","Y","N","N","N","Y","N","N","N","Y","N","N","N","Y","V",{"$f":"$A$49","v":"E.2.4"},{"$f":"$A$59","v":"E.3.4"},{"$f":"$A$86","v":"Part 1"},1,"Other - Please specify in the free text below",{"$f":"INDEX($AA$45:$AA$50,SMALL(IF(ISTEXT($AA$45:$AA$50),ROW($AA$1:$AA$6),\"\"),ROW(A5)))","v":"Other - Please specify in the free text below"}]
["E.2.5",126,"Significant changes to the ionising radiation risk statement in the PIS where the meaning of the text is substantially altered","Y","N","Y","N","Y","Y","N","N","N","Y","N","N","N","Y","N","N","N","Y","V",{"$f":"$A$48","v":"E.2.3"},{"$f":"$A$62","v":"E.3.7"},{"$f":"$A$87","v":"Part 2"},1,"Significant changes to the ionising radiation risk statement in the PIS where the meaning of the text is substantially altered",{"$f":"INDEX($AA$45:$AA$50,SMALL(IF(ISTEXT($AA$45:$AA$50),ROW($AA$1:$AA$6),\"\"),ROW(A6)))","v":"Significant changes to the ionising radiation risk statement in the PIS where the meaning of the text is substantially altered"}]
["E.2.6",0]
["E.2.7",56,"Medical_Devices_and_related_management_arrangements_Full",{"$f":"$D$1","v":"REC/MoDREC"},{"$f":"$E$1","v":"MHRA Meds"},{"$f":"$F$1","v":"MHRA Devs"},{"$f":"$G$1","v":"ARSAC"},{"$f":"$H$1","v":"Radiation"},{"$f":"$I$1","v":"UKSW"},{"$f":"$J$1","v":"REC (MCA)"},{"$f":"$K$1","v":"CAG"},{"$f":"$L$1","v":"HMPPS"},{"$f":"$M$1","v":"HRA HCRW"},{"$f":"$N$1","v":"REC (AWIA)"},{"$f":"$O$1","v":"PBPP"},{"$f":"$P$1","v":"SPS (RAEC)"},{"$f":"$Q$1","v":"NHS P"},{"$f":"$R$1","v":"HSC REC"},{"$f":"$S$1","v":"HSC DG"},{"$f":"$T$1","v":"Prisons"},{"$f":"$U$1","v":"HSC P"},{"$f":"$V$1","v":"Category"},{"$f":"$W$1","v":"Annex 2 Type"},{"$f":"$X$1","v":"Annex 2 Reason"},{"$f":"$Y$1","v":"CWoW"},{"$f":"$Z$1","v":"Applicability"}]
["N/A",0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"COUNTIF($Z$54:$Z$58,1)","v":5},null,"Medical_Devices_and_related_management_arrangements_5"]
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["Annex 2 Reason",24,"Changes requested by REC",{"$f":"$A$30","v":"Y"},"N",{"$f":"$A$30","v":"Y"},"N","N",{"$f":"$A$30","v":"Y"},"N","N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$49","v":"E.2.4"},{"$f":"$A$62","v":"E.3.7"},{"$f":"$A$87","v":"Part 2"},1,{"$f":"IF($Z55>0,$C55,0)","v":"Changes requested by REC"},{"$f":"INDEX($AA$54:$AA$58,SMALL(IF(ISTEXT($AA$54:$AA$58),ROW($AA$1:$AA$5),\"\"),ROW(A2)))","v":"Changes requested by REC"}]
["E.3.1",61,"Medical device(s) being added to the study for the first time",{"$f":"$A$30","v":"Y"},"N",{"$f":"$A$30","v":"Y"},"N","N",{"$f":"$A$30","v":"Y"},"N","N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$49","v":"E.2.4"},{"$f":"$A$62","v":"E.3.7"},{"$f":"$A$87","v":"Part 2"},1,{"$f":"IF($Z56>0,$C56,0)","v":"Medical device(s) being added to the study for the first time"},{"$f":"INDEX($AA$54:$AA$58,SMALL(IF(ISTEXT($AA$54:$AA$58),ROW($AA$1:$AA$5),\"\"),ROW(A3)))","v":"Medical device(s) being added to the study for the first time"}]
["E.3.2",45,"Other - Please specify in the free text below",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},"N","N",{"$f":"$A$30","v":"Y"},"N","N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$49","v":"E.2.4"},{"$f":"$A$62","v":"E.3.7"},{"$f":"$A$87","v":"Part 2"},1,{"$f":"IF($Z57>0,$C57,0)","v":"Other - Please specify in the free text below"},{"$f":"INDEX($AA$54:$AA$58,SMALL(IF(ISTEXT($AA$54:$AA$58),ROW($AA$1:$AA$5),\"\"),ROW(A4)))","v":"Other - Please specify in the free text below"}]
["E.3.3",133,"Protocol/clinical investigation plan/other study documentation - Changes to safety or clinical information relating to medical device",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},"N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$43","v":"V"},{"$f":"$A$47","v":"E.2.2"},{"$f":"$A$62","v":"E.3.7"},{"$f":"$A$86","v":"Part 1"},1,{"$f":"IF($Z58>0,$C58,0)","v":"Protocol/clinical investigation plan/other study documentation - Changes to safety or clinical information relating to medical device"},{"$f":"INDEX($AA$54:$AA$58,SMALL(IF(ISTEXT($AA$54:$AA$58),ROW($AA$1:$AA$5),\"\"),ROW(A5)))","v":"Protocol/clinical investigation plan/other study documentation - Changes to safety or clinical information relating to medical device"}]
["E.3.4",0]
["E.3.5",11,"MoDREC_Full",{"$f":"$D$1","v":"REC/MoDREC"},{"$f":"$E$1","v":"MHRA Meds"},{"$f":"$F$1","v":"MHRA Devs"},{"$f":"$G$1","v":"ARSAC"},{"$f":"$H$1","v":"Radiation"},{"$f":"$I$1","v":"UKSW"},{"$f":"$J$1","v":"REC (MCA)"},{"$f":"$K$1","v":"CAG"},{"$f":"$L$1","v":"HMPPS"},{"$f":"$M$1","v":"HRA HCRW"},{"$f":"$N$1","v":"REC (AWIA)"},{"$f":"$O$1","v":"PBPP"},{"$f":"$P$1","v":"SPS (RAEC)"},{"$f":"$Q$1","v":"NHS P"},{"$f":"$R$1","v":"HSC REC"},{"$f":"$S$1","v":"HSC DG"},{"$f":"$T$1","v":"Prisons"},{"$f":"$U$1","v":"HSC P"},{"$f":"$V$1","v":"Category"},{"$f":"$W$1","v":"Annex 2 Type"},{"$f":"$X$1","v":"Annex 2 Reason"},{"$f":"$Y$1","v":"CWoW"},{"$f":"$Z$1","v":"Applicability"}]
["E.3.6",0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"COUNTIF($Z$62,1)","v":1},null,"MoDREC_1"]
["E.3.7",42,"MoDREC specific amendments to be confirmed",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$49","v":"E.2.4"},{"$f":"$A$62","v":"E.3.7"},{"$f":"$A$87","v":"Part 2"},1,{"$f":"IF($Z62>0,$C62,0)","v":"MoDREC specific amendments to be confirmed"},{"$f":"INDEX($AA$62,SMALL(IF(ISTEXT($AA$62),ROW($AA$1:$AA$1),\"\"),ROW(A1)))","v":"MoDREC specific amendments to be confirmed"}]
["E.3.8",0]
["N/A",10,"Other_Full",{"$f":"$D$1","v":"REC/MoDREC"},{"$f":"$E$1","v":"MHRA Meds"},{"$f":"$F$1","v":"MHRA Devs"},{"$f":"$G$1","v":"ARSAC"},{"$f":"$H$1","v":"Radiation"},{"$f":"$I$1","v":"UKSW"},{"$f":"$J$1","v":"REC (MCA)"},{"$f":"$K$1","v":"CAG"},{"$f":"$L$1","v":"HMPPS"},{"$f":"$M$1","v":"HRA HCRW"},{"$f":"$N$1","v":"REC (AWIA)"},{"$f":"$O$1","v":"PBPP"},{"$f":"$P$1","v":"SPS (RAEC)"},{"$f":"$Q$1","v":"NHS P"},{"$f":"$R$1","v":"HSC REC"},{"$f":"$S$1","v":"HSC DG"},{"$f":"$T$1","v":"Prisons"},{"$f":"$U$1","v":"HSC P"},{"$f":"$V$1","v":"Category"},{"$f":"$W$1","v":"Annex 2 Type"},{"$f":"$X$1","v":"Annex 2 Reason"},{"$f":"$Y$1","v":"CWoW"},{"$f":"$Z$1","v":"Applicability"}]
[null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"COUNTIF($Z$66,1)","v":1},null,"Other_1"]
["CWoW",87,"E.g. Genetically Modified Organisms (HSE/DEFRA) - Please specify in the free text below",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$49","v":"E.2.4"},{"$f":"$A$62","v":"E.3.7"},{"$f":"$A$87","v":"Part 2"},1,{"$f":"IF($Z66>0,$C66,0)","v":"E.g. Genetically Modified Organisms (HSE/DEFRA) - Please specify in the free text below"},{"$f":"INDEX($AA$66,SMALL(IF(ISTEXT($AA$66),ROW($AA$1:$AA$1),\"\"),ROW(A1)))","v":"E.g. Genetically Modified Organisms (HSE/DEFRA) - Please specify in the free text below"}]
["No P1/2 - Administrative change",0]
["No P1/2 - CI change",{"$f":"LEN(C68)","v":27},"Participant_Procedures_Full",{"$f":"$D$1","v":"REC/MoDREC"},{"$f":"$E$1","v":"MHRA Meds"},{"$f":"$F$1","v":"MHRA Devs"},{"$f":"$G$1","v":"ARSAC"},{"$f":"$H$1","v":"Radiation"},{"$f":"$I$1","v":"UKSW"},{"$f":"$J$1","v":"REC (MCA)"},{"$f":"$K$1","v":"CAG"},{"$f":"$L$1","v":"HMPPS"},{"$f":"$M$1","v":"HRA HCRW"},{"$f":"$N$1","v":"REC (AWIA)"},{"$f":"$O$1","v":"PBPP"},{"$f":"$P$1","v":"SPS (RAEC)"},{"$f":"$Q$1","v":"NHS P"},{"$f":"$R$1","v":"HSC REC"},{"$f":"$S$1","v":"HSC DG"},{"$f":"$T$1","v":"Prisons"},{"$f":"$U$1","v":"HSC P"},{"$f":"$V$1","v":"Category"},{"$f":"$W$1","v":"Annex 2 Type"},{"$f":"$X$1","v":"Annex 2 Reason"},{"$f":"$Y$1","v":"CWoW"},{"$f":"$Z$1","v":"Applicability"}]
["No P1/2 - Sponsor change",0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"COUNTIF($Z$70:$Z$79,1)","v":8},null,"Participant_Procedures_6/8/10"]
["Part 1 - \"compliance with GMP\"",74,"Amendment following urgent safety measure(s) taken to protect participants",{"$f":"$A$30","v":"Y"},{"$f":"$A$30","v":"Y"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$50","v":"E.2.5"},{"$f":"$A$56","v":"E.3.1"},{"$f":"$A$86","v":"Part 1"},{"$f":"IF('Amendment Tool'!$AF$53=1,1,0)","v":1},{"$f":"IF($Z70>0,$C70,0)","v":"Amendment following urgent safety measure(s) taken to protect participants"},{"$f":"INDEX($AA$70:$AA$79,SMALL(IF(ISTEXT($AA$70:$AA$79),ROW($AA$1:$AA$10),\"\"),ROW(A1)))","v":"Amendment following urgent safety measure(s) taken to protect participants"}]
["Part 1 - \"protocol\"",95,"Mental Capacity - Change to the procedures/arrangements involving adults who lose/lack capacity",{"$f":"$A$33","v":"W"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$30","v":"Y"},{"$f":"$A$33","v":"W"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$33","v":"W"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$30","v":"Y"},{"$f":"$A$33","v":"W"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$47","v":"E.2.2"},{"$f":"$A$59","v":"E.3.4"},{"$f":"$A$87","v":"Part 2"},{"$f":"IF(AND('Amendment Tool'!$AE$68=1,'Amendment Tool'!$AF$68=1),1,0)","v":0},{"$f":"IF($Z71>0,$C71,0)","v":0},{"$f":"INDEX($AA$70:$AA$79,SMALL(IF(ISTEXT($AA$70:$AA$79),ROW($AA$1:$AA$10),\"\"),ROW(A2)))","v":"Other - Please specify in the free text below"}]
["Part 1 - \"protocol\"?",81,"Mental Capacity - Involvement of adults who lose/lack capacity for the first time",{"$f":"$A$33","v":"W"},{"$f":"$A$32","v":"N"},"Y","N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$33","v":"W"},{"$f":"$A$31","v":"(Y)"},"N",{"$f":"$A$30","v":"Y"},{"$f":"$A$33","v":"W"},"N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$33","v":"W"},"N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$47","v":"E.2.2"},{"$f":"$A$59","v":"E.3.4"},{"$f":"$A$86","v":"Part 1"},{"$f":"IF(AND('Amendment Tool'!$AE$68=1,'Amendment Tool'!$AF$68=1),1,0)","v":0},0,{"$f":"INDEX($AA$70:$AA$79,SMALL(IF(ISTEXT($AA$70:$AA$79),ROW($AA$1:$AA$10),\"\"),ROW(A3)))","v":"Participant procedures - minor change that can be implemented within existing resource at participating organisations - Please specify in the free text below"}]
["Part 1 - \"temporary halt\"",45,"Other - Please specify in the free text below",{"$f":"$A$30","v":"Y"},{"$f":"$A$30","v":"Y"},"Y","N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},"N",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$49","v":"E.2.4"},{"$f":"$A$62","v":"E.3.7"},{"$f":"$A$87","v":"Part 2"},1,"Other - Please specify in the free text below",{"$f":"INDEX($AA$70:$AA$79,SMALL(IF(ISTEXT($AA$70:$AA$79),ROW($AA$1:$AA$10),\"\"),ROW(A4)))","v":"Participant procedures - minor change that will have additional resource implications for participating organisations - Please specify in the free text below"}]
["Part 1 - IB, IMPD ish etc.",157,"Participant procedures - minor change that can be implemented within existing resource at participating organisations - Please specify in the free text below",{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},"Y","N","N",{"$f":"$A$31","v":"(Y)"},"N",{"$f":"$A$32","v":"N"},"N",{"$f":"$A$31","v":"(Y)"},"N","N","N",{"$f":"$A$31","v":"(Y)"},"N","N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$40","v":"C"},{"$f":"$A$53","v":"N/A"},{"$f":"$A$64","v":"N/A"},{"$f":"$A$85","v":"N/A"},1,"Participant procedures - minor change that can be implemented within existing resource at participating organisations - Please specify in the free text below",{"$f":"INDEX($AA$70:$AA$79,SMALL(IF(ISTEXT($AA$70:$AA$79),ROW($AA$1:$AA$10),\"\"),ROW(A5)))","v":"Participant procedures - significant change that can be implemented within existing resource at participating organisations - Please specify in the free text below"}]
["Part 1 - IB, IMPD ish etc. Split needed?",157,"Participant procedures - minor change that will have additional resource implications for participating organisations - Please specify in the free text below",{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},"Y","N","N",{"$f":"$A$31","v":"(Y)"},"N",{"$f":"$A$32","v":"N"},"N",{"$f":"$A$31","v":"(Y)"},"N","N","N",{"$f":"$A$31","v":"(Y)"},"N","N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$43","v":"V"},{"$f":"$A$53","v":"N/A"},{"$f":"$A$64","v":"N/A"},{"$f":"$A$85","v":"N/A"},1,"Participant procedures - minor change that will have additional resource implications for participating organisations - Please specify in the free text below",{"$f":"INDEX($AA$70:$AA$79,SMALL(IF(ISTEXT($AA$70:$AA$79),ROW($AA$1:$AA$10),\"\"),ROW(A6)))","v":"Participant procedures - significant change that will have additional resource implications for participating organisations - Please specify in the free text below"}]
["Part 1?",163,"Participant procedures - significant change that can be implemented within existing resource at participating organisations - Please specify in the free text below",{"$f":"$A$30","v":"Y"},{"$f":"$A$30","v":"Y"},"Y","N","N",{"$f":"$A$30","v":"Y"},"N",{"$f":"$A$32","v":"N"},"N",{"$f":"$A$30","v":"Y"},"N","N","N",{"$f":"$A$30","v":"Y"},"N","N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$40","v":"C"},{"$f":"$A$49","v":"E.2.4"},{"$f":"$A$59","v":"E.3.4"},{"$f":"$A$86","v":"Part 1"},1,"Participant procedures - significant change that can be implemented within existing resource at participating organisations - Please specify in the free text below",{"$f":"INDEX($AA$70:$AA$79,SMALL(IF(ISTEXT($AA$70:$AA$79),ROW($AA$1:$AA$10),\"\"),ROW(A7)))","v":"Recruitment - Change in identification, approach, recruitment or consent of participants"}]
["Part 2 - \"data protection\"",163,"Participant procedures - significant change that will have additional resource implications for participating organisations - Please specify in the free text below",{"$f":"$A$30","v":"Y"},{"$f":"$A$30","v":"Y"},"Y","N","N",{"$f":"$A$30","v":"Y"},"N",{"$f":"$A$32","v":"N"},"N",{"$f":"$A$30","v":"Y"},"N","N","N",{"$f":"$A$30","v":"Y"},"N","N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$49","v":"E.2.4"},{"$f":"$A$59","v":"E.3.4"},{"$f":"$A$86","v":"Part 1"},1,"Participant procedures - significant change that will have additional resource implications for participating organisations - Please specify in the free text below",{"$f":"INDEX($AA$70:$AA$79,SMALL(IF(ISTEXT($AA$70:$AA$79),ROW($AA$1:$AA$10),\"\"),ROW(A8)))","v":"Wellbeing - Change relating to the safety, physical or mental integrity of participants, or to the risk/benefit assessment"}]
["Part 2 - \"insurance\"",88,"Recruitment - Change in identification, approach, recruitment or consent of participants",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"Y","N","N",{"$f":"$A$30","v":"Y"},"N",{"$f":"$A$31","v":"(Y)"},"N",{"$f":"$A$30","v":"Y"},"N","N","N",{"$f":"$A$30","v":"Y"},"N","N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$49","v":"E.2.4"},{"$f":"$A$59","v":"E.3.4"},{"$f":"$A$87","v":"Part 2"},1,{"$f":"IF($Z78>0,$C78,0)","v":"Recruitment - Change in identification, approach, recruitment or consent of participants"},{"$f":"INDEX($AA$70:$AA$79,SMALL(IF(ISTEXT($AA$70:$AA$79),ROW($AA$1:$AA$10),\"\"),ROW(A9)))","v":{"$error":"#NUM!"}}]
["Part 2 - \"new site\"",122,"Wellbeing - Change relating to the safety, physical or mental integrity of participants, or to the risk/benefit assessment",{"$f":"$A$30","v":"Y"},{"$f":"$A$30","v":"Y"},"Y","N","N",{"$f":"$A$31","v":"(Y)"},"N",{"$f":"$A$32","v":"N"},"N",{"$f":"$A$31","v":"(Y)"},"N","N","N",{"$f":"$A$31","v":"(Y)"},"N","N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$43","v":"V"},{"$f":"$A$49","v":"E.2.4"},{"$f":"$A$56","v":"E.3.1"},{"$f":"$A$86","v":"Part 1"},{"$f":"IF('Amendment Tool'!$AF$53=1,1,0)","v":1},{"$f":"IF($Z79>0,$C79,0)","v":"Wellbeing - Change relating to the safety, physical or mental integrity of participants, or to the risk/benefit assessment"},{"$f":"INDEX($AA$70:$AA$79,SMALL(IF(ISTEXT($AA$70:$AA$79),ROW($AA$1:$AA$10),\"\"),ROW(A10)))","v":{"$error":"#NUM!"}}]
["Part 2 - \"new/change to investigator/site\"",0]
["Part 2 - \"participant information\"",32,"Participating_Organisations_Full",{"$f":"$D$1","v":"REC/MoDREC"},{"$f":"$E$1","v":"MHRA Meds"},{"$f":"$F$1","v":"MHRA Devs"},{"$f":"$G$1","v":"ARSAC"},{"$f":"$H$1","v":"Radiation"},{"$f":"$I$1","v":"UKSW"},{"$f":"$J$1","v":"REC (MCA)"},{"$f":"$K$1","v":"CAG"},{"$f":"$L$1","v":"HMPPS"},{"$f":"$M$1","v":"HRA HCRW"},{"$f":"$N$1","v":"REC (AWIA)"},{"$f":"$O$1","v":"PBPP"},{"$f":"$P$1","v":"SPS (RAEC)"},{"$f":"$Q$1","v":"NHS P"},{"$f":"$R$1","v":"HSC REC"},{"$f":"$S$1","v":"HSC DG"},{"$f":"$T$1","v":"Prisons"},{"$f":"$U$1","v":"HSC P"},{"$f":"$V$1","v":"Category"},{"$f":"$W$1","v":"Annex 2 Type"},{"$f":"$X$1","v":"Annex 2 Reason"},{"$f":"$Y$1","v":"CWoW"},{"$f":"$Z$1","v":"Applicability"}]
["Part 2 - \"PIS,CF, other, questionnaires\" - need to be more granular? Need to split out inv letter?",0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"COUNTIF($Z$83:$Z$89,1)","v":7},null,"Participating_Organisations_2/7"]
["Part 2 - \"recruitment process\"",110,"Addition of new sites undertaking different activities, or a change to activities undertaken by existing sites",{"$f":"IF('Amendment Tool'!$AI$83=1,'Menu Data'!$A$33,'Menu Data'!$A$34)","v":"Z"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$30","v":"Y"},{"$f":"IF(OR('Amendment Tool'!$AJ$83=1,'Amendment Tool'!$AK$83=1),'Menu Data'!$A$33,'Menu Data'!$A$32)","v":"N"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"IF('Amendment Tool'!$AL$83=1,'Menu Data'!$A$33,'Menu Data'!$A$32)","v":"N"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$30","v":"Y"},{"$f":"IF('Amendment Tool'!$AM$83=1,'Menu Data'!$A$33,'Menu Data'!$A$32)","v":"N"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$46","v":"E.2.1"},{"$f":"$A$61","v":"E.3.6"},{"$f":"$A$87","v":"Part 2"},1,{"$f":"IF($Z83>0,$C83,0)","v":"Addition of new sites undertaking different activities, or a change to activities undertaken by existing sites"},{"$f":"INDEX($AA$83:$AA$89,SMALL(IF(ISTEXT($AA$83:$AA$89),ROW($AA$1:$AA$7),\"\"),ROW(A1)))","v":"Addition of new sites undertaking different activities, or a change to activities undertaken by existing sites"}]
["Part 2?",67,"Addition of sites undertaking the same activities as existing sites",{"$f":"IF('Amendment Tool'!$AI$83=1,'Menu Data'!$A$33,'Menu Data'!$A$34)","v":"Z"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$31","v":"(Y)"},{"$f":"IF(OR('Amendment Tool'!$AJ$83=1,'Amendment Tool'!$AK$83=1),'Menu Data'!$A$33,'Menu Data'!$A$32)","v":"N"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},{"$f":"IF('Amendment Tool'!$AL$83=1,'Menu Data'!$A$33,'Menu Data'!$A$32)","v":"N"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$31","v":"(Y)"},{"$f":"IF('Amendment Tool'!$AM$83=1,'Menu Data'!$A$33,'Menu Data'!$A$32)","v":"N"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$31","v":"(Y)"},{"$f":"IF('Amendment Tool'!$AI$83=1,'Menu Data'!$A$43,'Menu Data'!$A$41)","v":"New site"},{"$f":"$A$46","v":"E.2.1"},{"$f":"$A$61","v":"E.3.6"},{"$f":"$A$87","v":"Part 2"},1,"Addition of sites undertaking the same activities as existing sites",{"$f":"INDEX($AA$83:$AA$89,SMALL(IF(ISTEXT($AA$83:$AA$89),ROW($AA$1:$AA$7),\"\"),ROW(A2)))","v":"Addition of sites undertaking the same activities as existing sites"}]
["N/A",45,"Early closure or withdrawal of research sites",{"$f":"$A$34","v":"Z"},"N",{"$f":"$A$30","v":"Y"},"N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},"N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$43","v":"V"},{"$f":"$A$46","v":"E.2.1"},{"$f":"$A$61","v":"E.3.6"},{"$f":"$A$87","v":"Part 2"},{"$f":"IF(AND('Amendment Tool'!$AE$95=1,'Amendment Tool'!$AF$91=5),0,1)","v":1},"Early closure or withdrawal of research sites",{"$f":"INDEX($AA$83:$AA$89,SMALL(IF(ISTEXT($AA$83:$AA$89),ROW($AA$1:$AA$7),\"\"),ROW(A3)))","v":"Early closure or withdrawal of research sites"}]
["Part 1",45,"Other - Please specify in the free text below",{"$f":"$A$30","v":"Y"},"N",{"$f":"$A$30","v":"Y"},"N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},"N",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$49","v":"E.2.4"},{"$f":"$A$61","v":"E.3.6"},{"$f":"$A$87","v":"Part 2"},{"$f":"IF(AND('Amendment Tool'!$AE$95=1,'Amendment Tool'!$AF$91=5),0,1)","v":1},"Other - Please specify in the free text below",{"$f":"INDEX($AA$83:$AA$89,SMALL(IF(ISTEXT($AA$83:$AA$89),ROW($AA$1:$AA$7),\"\"),ROW(A4)))","v":"Other - Please specify in the free text below"}]
["Part 2",127,"PICs - Addition of Participant Identification Centres for the first time, or a change to activities undertaken by existing PICs",{"$f":"$A$32","v":"N"},"N",{"$f":"$A$30","v":"Y"},"N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},"N",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$53","v":"N/A"},{"$f":"$A$64","v":"N/A"},{"$f":"$A$85","v":"N/A"},{"$f":"IF(AND('Amendment Tool'!$AE$95=1,'Amendment Tool'!$AF$91=5),0,1)","v":1},"PICs - Addition of Participant Identification Centres for the first time, or a change to activities undertaken by existing PICs",{"$f":"INDEX($AA$83:$AA$89,SMALL(IF(ISTEXT($AA$83:$AA$89),ROW($AA$1:$AA$7),\"\"),ROW(A5)))","v":"PICs - Addition of Participant Identification Centres for the first time, or a change to activities undertaken by existing PICs"}]
[null,102,"PICs - Addition of Participant Identification Centres undertaking the same activities as existing PICs",{"$f":"$A$32","v":"N"},"N",{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$41","v":"New site"},{"$f":"$A$53","v":"N/A"},{"$f":"$A$64","v":"N/A"},{"$f":"$A$85","v":"N/A"},{"$f":"IF(AND('Amendment Tool'!$AE$95=1,'Amendment Tool'!$AF$91=5),0,1)","v":1},"PICs - Addition of Participant Identification Centres undertaking the same activities as existing PICs",{"$f":"INDEX($AA$83:$AA$89,SMALL(IF(ISTEXT($AA$83:$AA$89),ROW($AA$1:$AA$7),\"\"),ROW(A6)))","v":"PICs - Addition of Participant Identification Centres undertaking the same activities as existing PICs"}]
["Specific study",72,"PICs - Early closure or withdrawal of Participant Identification Centres",{"$f":"$A$32","v":"N"},"N",{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$43","v":"V"},{"$f":"$A$53","v":"N/A"},{"$f":"$A$64","v":"N/A"},{"$f":"$A$85","v":"N/A"},{"$f":"IF(AND('Amendment Tool'!$AE$95=1,'Amendment Tool'!$AF$91=5),0,1)","v":1},"PICs - Early closure or withdrawal of Participant Identification Centres",{"$f":"INDEX($AA$83:$AA$89,SMALL(IF(ISTEXT($AA$83:$AA$89),ROW($AA$1:$AA$7),\"\"),ROW(A7)))","v":"PICs - Early closure or withdrawal of Participant Identification Centres"}]
["Research tissue bank",0]
["Research database",14,"Prisoners_Full",{"$f":"$D$1","v":"REC/MoDREC"},{"$f":"$E$1","v":"MHRA Meds"},{"$f":"$F$1","v":"MHRA Devs"},{"$f":"$G$1","v":"ARSAC"},{"$f":"$H$1","v":"Radiation"},{"$f":"$I$1","v":"UKSW"},{"$f":"$J$1","v":"REC (MCA)"},{"$f":"$K$1","v":"CAG"},{"$f":"$L$1","v":"HMPPS"},{"$f":"$M$1","v":"HRA HCRW"},{"$f":"$N$1","v":"REC (AWIA)"},{"$f":"$O$1","v":"PBPP"},{"$f":"$P$1","v":"SPS (RAEC)"},{"$f":"$Q$1","v":"NHS P"},{"$f":"$R$1","v":"HSC REC"},{"$f":"$S$1","v":"HSC DG"},{"$f":"$T$1","v":"Prisons"},{"$f":"$U$1","v":"HSC P"},{"$f":"$V$1","v":"Category"},{"$f":"$W$1","v":"Annex 2 Type"},{"$f":"$X$1","v":"Annex 2 Reason"},{"$f":"$Y$1","v":"CWoW"},{"$f":"$Z$1","v":"Applicability"}]
[null,0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"COUNTIF($Z$93:$Z$94,1)","v":2},null,"Prisoners_2"]
["NHS/HSC REC",45,"Other - Please specify in the free text below",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$30","v":"Y"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$49","v":"E.2.4"},{"$f":"$A$59","v":"E.3.4"},{"$f":"$A$87","v":"Part 2"},1,{"$f":"IF($Z93>0,$C93,0)","v":"Other - Please specify in the free text below"},{"$f":"INDEX($AA$93:$AA$94,SMALL(IF(ISTEXT($AA$93:$AA$94),ROW($AA$1:$AA$2),\"\"),ROW(A1)))","v":"Other - Please specify in the free text below"}]
["Ministry of Defence (MoDREC)",64,"Prison service is being involved in the study for the first time",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$30","v":"Y"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$49","v":"E.2.4"},{"$f":"$A$59","v":"E.3.4"},{"$f":"$A$87","v":"Part 2"},1,{"$f":"IF($Z94>0,$C94,0)","v":"Prison service is being involved in the study for the first time"},{"$f":"INDEX($AA$93:$AA$94,SMALL(IF(ISTEXT($AA$93:$AA$94),ROW($AA$1:$AA$2),\"\"),ROW(A2)))","v":"Prison service is being involved in the study for the first time"}]
[null,0]
["England",27,"Radioactive_Substances_Full",{"$f":"$D$1","v":"REC/MoDREC"},{"$f":"$E$1","v":"MHRA Meds"},{"$f":"$F$1","v":"MHRA Devs"},{"$f":"$G$1","v":"ARSAC"},{"$f":"$H$1","v":"Radiation"},{"$f":"$I$1","v":"UKSW"},{"$f":"$J$1","v":"REC (MCA)"},{"$f":"$K$1","v":"CAG"},{"$f":"$L$1","v":"HMPPS"},{"$f":"$M$1","v":"HRA HCRW"},{"$f":"$N$1","v":"REC (AWIA)"},{"$f":"$O$1","v":"PBPP"},{"$f":"$P$1","v":"SPS (RAEC)"},{"$f":"$Q$1","v":"NHS P"},{"$f":"$R$1","v":"HSC REC"},{"$f":"$S$1","v":"HSC DG"},{"$f":"$T$1","v":"Prisons"},{"$f":"$U$1","v":"HSC P"},{"$f":"$V$1","v":"Category"},{"$f":"$W$1","v":"Annex 2 Type"},{"$f":"$X$1","v":"Annex 2 Reason"},{"$f":"$Y$1","v":"CWoW"},{"$f":"$Z$1","v":"Applicability"}]
["Wales",0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"COUNTIF($Z$98:$Z$102,1)","v":5},null,"Radioactive_Substances_5"]
["Scotland",164,"Addition of a new study population with a different clinical condition for the administration of radioactive substances (including changing the age of participants)",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},"Y","Y","Y",{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$47","v":"E.2.2"},{"$f":"$A$59","v":"E.3.4"},{"$f":"$A$86","v":"Part 1"},1,{"$f":"IF($Z98>0,$C98,0)","v":"Addition of a new study population with a different clinical condition for the administration of radioactive substances (including changing the age of participants)"},{"$f":"INDEX($AA$98:$AA$102,SMALL(IF(ISTEXT($AA$98:$AA$102),ROW($AA$1:$AA$5),\"\"),ROW(A1)))","v":"Addition of a new study population with a different clinical condition for the administration of radioactive substances (including changing the age of participants)"}]
["Northern Ireland",85,"Addition or removal of a procedure involving administration of radioactive substances",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"Y","Y","Y","Y","N","N","N",{"$f":"$A$30","v":"Y"},"N","N","N",{"$f":"$A$30","v":"Y"},"N","N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$47","v":"E.2.2"},{"$f":"$A$59","v":"E.3.4"},{"$f":"$A$86","v":"Part 1"},1,{"$f":"IF($Z99>0,$C99,0)","v":"Addition or removal of a procedure involving administration of radioactive substances"},{"$f":"INDEX($AA$98:$AA$102,SMALL(IF(ISTEXT($AA$98:$AA$102),ROW($AA$1:$AA$5),\"\"),ROW(A2)))","v":"Addition or removal of a procedure involving administration of radioactive substances"}]
[null,66,"Changes to the number of administrations of radioactive substances",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"Y","Y","Y","Y","N","N","N",{"$f":"$A$30","v":"Y"},"N","N","N",{"$f":"$A$30","v":"Y"},"N","N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$47","v":"E.2.2"},{"$f":"$A$59","v":"E.3.4"},{"$f":"$A$86","v":"Part 1"},1,{"$f":"IF($Z100>0,$C100,0)","v":"Changes to the number of administrations of radioactive substances"},{"$f":"INDEX($AA$98:$AA$102,SMALL(IF(ISTEXT($AA$98:$AA$102),ROW($AA$1:$AA$5),\"\"),ROW(A3)))","v":"Changes to the number of administrations of radioactive substances"}]
["Chief Investigator",135,"Changes to the radiation risk information in the PIS following changes to the protocol for the administration of radioactive substances",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"Y","Y","Y","Y","N","N","N",{"$f":"$A$30","v":"Y"},"N","N","N",{"$f":"$A$30","v":"Y"},"N","N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$48","v":"E.2.3"},{"$f":"$A$62","v":"E.3.7"},{"$f":"$A$87","v":"Part 2"},1,{"$f":"IF($Z101>0,$C101,0)","v":"Changes to the radiation risk information in the PIS following changes to the protocol for the administration of radioactive substances"},{"$f":"INDEX($AA$98:$AA$102,SMALL(IF(ISTEXT($AA$98:$AA$102),ROW($AA$1:$AA$5),\"\"),ROW(A4)))","v":"Changes to the radiation risk information in the PIS following changes to the protocol for the administration of radioactive substances"}]
["Sponsor",96,"Other - Please check with ARSAC before submitting this amendment. Specify in the free text below",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"Y","Y","Y","Y","N","N","N",{"$f":"$A$30","v":"Y"},"N","N","N",{"$f":"$A$30","v":"Y"},"N","N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$49","v":"E.2.4"},{"$f":"$A$59","v":"E.3.4"},{"$f":"$A$87","v":"Part 2"},1,{"$f":"IF($Z102>0,$C102,0)","v":"Other - Please check with ARSAC before submitting this amendment. Specify in the free text below"},{"$f":"INDEX($AA$98:$AA$102,SMALL(IF(ISTEXT($AA$98:$AA$102),ROW($AA$1:$AA$5),\"\"),ROW(A5)))","v":"Other - Please check with ARSAC before submitting this amendment. Specify in the free text below"}]
["Administrative",0]
["Project Information",16,"Researchers_Full",{"$f":"$D$1","v":"REC/MoDREC"},{"$f":"$E$1","v":"MHRA Meds"},{"$f":"$F$1","v":"MHRA Devs"},{"$f":"$G$1","v":"ARSAC"},{"$f":"$H$1","v":"Radiation"},{"$f":"$I$1","v":"UKSW"},{"$f":"$J$1","v":"REC (MCA)"},{"$f":"$K$1","v":"CAG"},{"$f":"$L$1","v":"HMPPS"},{"$f":"$M$1","v":"HRA HCRW"},{"$f":"$N$1","v":"REC (AWIA)"},{"$f":"$O$1","v":"PBPP"},{"$f":"$P$1","v":"SPS (RAEC)"},{"$f":"$Q$1","v":"NHS P"},{"$f":"$R$1","v":"HSC REC"},{"$f":"$S$1","v":"HSC DG"},{"$f":"$T$1","v":"Prisons"},{"$f":"$U$1","v":"HSC P"},{"$f":"$V$1","v":"Category"},{"$f":"$W$1","v":"Annex 2 Type"},{"$f":"$X$1","v":"Annex 2 Reason"},{"$f":"$Y$1","v":"CWoW"},{"$f":"$Z$1","v":"Applicability"}]
["New site/PI only",0,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,{"$f":"COUNTIF($Z$106:$Z$113,1)","v":6},null,"Researchers_1/2/3/4/5/6/7/8"]
[null,52,"Changes to the research team (other than CIs or PIs)",{"$f":"$A$32","v":"N"},"N","N","N","N","N","N","N","N","N","N","N","N","N","N","N","N","N",{"$f":"$A$42","v":"N/A"},{"$f":"$A$53","v":"N/A"},{"$f":"$A$64","v":"N/A"},{"$f":"$A$85","v":"N/A"},{"$f":"IF(AND('Amendment Tool'!$AE$95=1,'Amendment Tool'!$AF$91=5),0,1)","v":1},{"$f":"IF($Z106>0,$C106,0)","v":"Changes to the research team (other than CIs or PIs)"},{"$f":"INDEX($AA$106:$AA$113,SMALL(IF(ISTEXT($AA$106:$AA$113),ROW($AA$1:$AA$8),\"\"),ROW(A1)))","v":"Changes to the research team (other than CIs or PIs)"}]
["Yes",67,"CI - New CI, or temporary arrangements to cover the absence of a CI",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$30","v":"Y"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$30","v":"Y"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$30","v":"Y"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$40","v":"C"},{"$f":"$A$46","v":"E.2.1"},{"$f":"$A$60","v":"E.3.5"},{"$f":"$A$85","v":"N/A"},{"$f":"IF(AND('Amendment Tool'!$AE$95=1,'Amendment Tool'!$AF$91=5),0,IF(AND('Amendment Tool'!$AE$61=1,'Amendment Tool'!$AF$61=1),0,1))","v":1},"CI - New CI, or temporary arrangements to cover the absence of a CI",{"$f":"INDEX($AA$106:$AA$113,SMALL(IF(ISTEXT($AA$106:$AA$113),ROW($AA$1:$AA$8),\"\"),ROW(A2)))","v":"CI - New CI, or temporary arrangements to cover the absence of a CI"}]
["No",41,"CI - Possible conflict of interest for CI",{"$f":"$A$30","v":"Y"},"N","Y","N","N",{"$f":"$A$31","v":"(Y)"},"N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},"N","N",{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},"N","N",{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$40","v":"C"},{"$f":"$A$53","v":"N/A"},{"$f":"$A$63","v":"E.3.8"},{"$f":"$A$87","v":"Part 2"},{"$f":"IF(AND('Amendment Tool'!$AE$95=1,'Amendment Tool'!$AF$91=5),0,1)","v":1},"CI - Possible conflict of interest for CI",{"$f":"INDEX($AA$106:$AA$113,SMALL(IF(ISTEXT($AA$106:$AA$113),ROW($AA$1:$AA$8),\"\"),ROW(A3)))","v":"CI - Possible conflict of interest for CI"}]
[null,45,"Other - Please specify in the free text below",{"$f":"$A$32","v":"N"},"N","Y","N","N",{"$f":"$A$30","v":"Y"},"N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},"N","N",{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},"N","N",{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$53","v":"N/A"},{"$f":"$A$64","v":"N/A"},{"$f":"$A$85","v":"N/A"},{"$f":"IF(AND('Amendment Tool'!$AE$95=1,'Amendment Tool'!$AF$91=5),0,1)","v":1},"Other - Please specify in the free text below",{"$f":"INDEX($AA$106:$AA$113,SMALL(IF(ISTEXT($AA$106:$AA$113),ROW($AA$1:$AA$8),\"\"),ROW(A4)))","v":"Other - Please specify in the free text below"}]
[null,67,"PI - New PI, or temporary arrangements to cover the absence of a PI",{"$f":"$A$34","v":"Z"},"N","Y","N","N",{"$f":"$A$31","v":"(Y)"},"N",{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},"N","N",{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},"N","N",{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$43","v":"V"},{"$f":"$A$46","v":"E.2.1"},{"$f":"$A$60","v":"E.3.5"},{"$f":"$A$87","v":"Part 2"},1,"PI - New PI, or temporary arrangements to cover the absence of a PI",{"$f":"INDEX($AA$106:$AA$113,SMALL(IF(ISTEXT($AA$106:$AA$113),ROW($AA$1:$AA$8),\"\"),ROW(A5)))","v":"PI - New PI, or temporary arrangements to cover the absence of a PI"}]
[null,41,"PI - Possible conflict of interest for PI",{"$f":"$A$30","v":"Y"},"N","Y","N","N",{"$f":"$A$31","v":"(Y)"},"N",{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},"N","N",{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},"N","N",{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$43","v":"V"},{"$f":"$A$53","v":"N/A"},{"$f":"$A$63","v":"E.3.8"},{"$f":"$A$87","v":"Part 2"},{"$f":"IF(AND('Amendment Tool'!$AE$95=1,'Amendment Tool'!$AF$91=5),0,1)","v":1},"PI - Possible conflict of interest for PI",{"$f":"INDEX($AA$106:$AA$113,SMALL(IF(ISTEXT($AA$106:$AA$113),ROW($AA$1:$AA$8),\"\"),ROW(A6)))","v":"PI - Possible conflict of interest for PI"}]
[null,77,"Prisons - Change involving PI responsible for the study at the prison service",{"$f":"$A$34","v":"Z"},"N","Y","N","N",{"$f":"$A$31","v":"(Y)"},"N",{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$31","v":"(Y)"},"N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$31","v":"(Y)"},"N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$40","v":"C"},{"$f":"$A$46","v":"E.2.1"},{"$f":"$A$60","v":"E.3.5"},{"$f":"$A$87","v":"Part 2"},{"$f":"IF(AND('Amendment Tool'!$AE$95=1,'Amendment Tool'!$AF$91=5),0,IF(AND('Amendment Tool'!$AE$70=1,'Amendment Tool'!$AF$70=1),1,0))","v":0},0,{"$f":"INDEX($AA$106:$AA$113,SMALL(IF(ISTEXT($AA$106:$AA$113),ROW($AA$1:$AA$8),\"\"),ROW(A7)))","v":{"$error":"#NUM!"}}]
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[null,0]
[null,20,"Stop_or_Restart_Full",{"$f":"$D$1","v":"REC/MoDREC"},{"$f":"$E$1","v":"MHRA Meds"},{"$f":"$F$1","v":"MHRA Devs"},{"$f":"$G$1","v":"ARSAC"},{"$f":"$H$1","v":"Radiation"},{"$f":"$I$1","v":"UKSW"},{"$f":"$J$1","v":"REC (MCA)"},{"$f":"$K$1","v":"CAG"},{"$f":"$L$1","v":"HMPPS"},{"$f":"$M$1","v":"HRA HCRW"},{"$f":"$N$1","v":"REC (AWIA)"},{"$f":"$O$1","v":"PBPP"},{"$f":"$P$1","v":"SPS (RAEC)"},{"$f":"$Q$1","v":"NHS P"},{"$f":"$R$1","v":"HSC REC"},{"$f":"$S$1","v":"HSC DG"},{"$f":"$T$1","v":"Prisons"},{"$f":"$U$1","v":"HSC P"},{"$f":"$V$1","v":"Category"},{"$f":"$W$1","v":"Annex 2 Type"},{"$f":"$X$1","v":"Annex 2 Reason"},{"$f":"$Y$1","v":"CWoW"},{"$f":"$Z$1","v":"Applicability"}]
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[null,45,"Other - Please specify in the free text below",{"$f":"$A$30","v":"Y"},{"$f":"$A$30","v":"Y"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},"N",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$49","v":"E.2.4"},{"$f":"$A$59","v":"E.3.4"},{"$f":"$A$86","v":"Part 1"},1,{"$f":"IF($Z117>0,$C117,0)","v":"Other - Please specify in the free text below"},{"$f":"INDEX($AA$117:$AA$124,SMALL(IF(ISTEXT($AA$117:$AA$124),ROW($AA$1:$AA$8),\"\"),ROW(A1)))","v":"Other - Please specify in the free text below"}]
[null,61,"Permanent closure or withdrawal of a non-interventional study",{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$40","v":"C"},{"$f":"$A$53","v":"N/A"},{"$f":"$A$53","v":"N/A"},{"$f":"$A$53","v":"N/A"},{"$f":"IF($Z$119=1,0,1)","v":1},"Permanent closure or withdrawal of a non-interventional study",{"$f":"INDEX($AA$117:$AA$124,SMALL(IF(ISTEXT($AA$117:$AA$124),ROW($AA$1:$AA$8),\"\"),ROW(A2)))","v":"Permanent closure or withdrawal of a non-interventional study"}]
[null,168,"Permanent closure or withdrawal of an interventional study where the arrangements for post-study care will be in line with those previously described to the participant",{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},"Y",{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},"(Y)","N","(Y)","N","(Y)","N","N","N","(Y)","N","N","N","(Y)",{"$f":"$A$40","v":"C"},{"$f":"$A$49","v":"E.2.4"},{"$f":"$A$59","v":"E.3.4"},{"$f":"$A$86","v":"Part 1"},{"$f":"IF(OR('Amendment Tool'!$AF$60=1,'Amendment Tool'!$AF$63=1),1,0)","v":0},0,{"$f":"INDEX($AA$117:$AA$124,SMALL(IF(ISTEXT($AA$117:$AA$124),ROW($AA$1:$AA$8),\"\"),ROW(A3)))","v":"Restart of study following a temporary halt"}]
[null,164,"Permanent closure or withdrawal of an interventional study where the arrangements for post-study care will differ from those previously described to the participant",{"$f":"$A$30","v":"Y"},"Y","Y",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},"(Y)","N","(Y)","N","(Y)","N","N","N","(Y)","N","N","N","(Y)",{"$f":"$A$43","v":"V"},{"$f":"$A$49","v":"E.2.4"},{"$f":"$A$59","v":"E.3.4"},{"$f":"$A$86","v":"Part 1"},{"$f":"IF(OR('Amendment Tool'!$AF$60=1,'Amendment Tool'!$AF$63=1),1,0)","v":0},0,{"$f":"INDEX($AA$117:$AA$124,SMALL(IF(ISTEXT($AA$117:$AA$124),ROW($AA$1:$AA$8),\"\"),ROW(A4)))","v":"Temporary halt of non-CTIMP"}]
[null,43,"Restart of study following a temporary halt",{"$f":"$A$30","v":"Y"},"Y","Y",{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},"(Y)","N","(Y)","N","(Y)","N","N","N","(Y)","N","N","N","(Y)",{"$f":"$A$43","v":"V"},{"$f":"$A$52","v":"E.2.7"},{"$f":"$A$59","v":"E.3.4"},{"$f":"$A$86","v":"Part 1"},1,"Restart of study following a temporary halt",{"$f":"INDEX($AA$117:$AA$124,SMALL(IF(ISTEXT($AA$117:$AA$124),ROW($AA$1:$AA$8),\"\"),ROW(A5)))","v":"Temporary halt of non-CTIMP due to COVID-19"}]
[null,23,"Temporary halt of CTIMP",{"$f":"$A$30","v":"Y"},"Y","Y",{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},"(Y)","N","(Y)","N","(Y)","N","N","N","(Y)","N","N","N","(Y)",{"$f":"$A$43","v":"V"},{"$f":"$A$51","v":"E.2.6"},{"$f":"$A$59","v":"E.3.4"},{"$f":"$A$86","v":"Part 1"},{"$f":"IF(AND('Amendment Tool'!$AE$60=1,'Amendment Tool'!$AF$60=1),1,0)","v":0},0,{"$f":"INDEX($AA$117:$AA$124,SMALL(IF(ISTEXT($AA$117:$AA$124),ROW($AA$1:$AA$8),\"\"),ROW(A6)))","v":{"$error":"#NUM!"}}]
[null,27,"Temporary halt of non-CTIMP",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},"(Y)","N","(Y)","N","(Y)","N","N","N","(Y)","N","N","N","(Y)",{"$f":"$A$43","v":"V"},{"$f":"$A$53","v":"N/A"},"N/A","N/A",{"$f":"IF($Z$122=1,0,1)","v":1},"Temporary halt of non-CTIMP",{"$f":"INDEX($AA$117:$AA$124,SMALL(IF(ISTEXT($AA$117:$AA$124),ROW($AA$1:$AA$8),\"\"),ROW(A7)))","v":{"$error":"#NUM!"}}]
[null,43,"Temporary halt of non-CTIMP due to COVID-19",{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},"(Y)","N","(Y)","N","(Y)","N","N","N","(Y)","N","N","N","(Y)",{"$f":"$A$40","v":"C"},"N/A","N/A","N/A",{"$f":"IF($Z$122=1,0,1)","v":1},"Temporary halt of non-CTIMP due to COVID-19",{"$f":"INDEX($AA$117:$AA$124,SMALL(IF(ISTEXT($AA$117:$AA$124),ROW($AA$1:$AA$8),\"\"),ROW(A8)))","v":{"$error":"#NUM!"}}]
[null,0]
[null,17,"Study_Design_Full",{"$f":"$D$1","v":"REC/MoDREC"},{"$f":"$E$1","v":"MHRA Meds"},{"$f":"$F$1","v":"MHRA Devs"},{"$f":"$G$1","v":"ARSAC"},{"$f":"$H$1","v":"Radiation"},{"$f":"$I$1","v":"UKSW"},{"$f":"$J$1","v":"REC (MCA)"},{"$f":"$K$1","v":"CAG"},{"$f":"$L$1","v":"HMPPS"},{"$f":"$M$1","v":"HRA HCRW"},{"$f":"$N$1","v":"REC (AWIA)"},{"$f":"$O$1","v":"PBPP"},{"$f":"$P$1","v":"SPS (RAEC)"},{"$f":"$Q$1","v":"NHS P"},{"$f":"$R$1","v":"HSC REC"},{"$f":"$S$1","v":"HSC DG"},{"$f":"$T$1","v":"Prisons"},{"$f":"$U$1","v":"HSC P"},{"$f":"$V$1","v":"Category"},{"$f":"$W$1","v":"Annex 2 Type"},{"$f":"$X$1","v":"Annex 2 Reason"},{"$f":"$Y$1","v":"CWoW"},{"$f":"$Z$1","v":"Applicability"}]
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[null,70,"Background information - Change that affects scientific value of study",{"$f":"$A$30","v":"Y"},{"$f":"$A$30","v":"Y"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},"N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$43","v":"V"},{"$f":"$A$49","v":"E.2.4"},{"$f":"$A$57","v":"E.3.2"},{"$f":"$A$86","v":"Part 1"},1,{"$f":"IF($Z128>0,$C128,0)","v":"Background information - Change that affects scientific value of study"},{"$f":"INDEX($AA$128:$AA$144,SMALL(IF(ISTEXT($AA$128:$AA$144),ROW($AA$1:$AA$17),\"\"),ROW(A1)))","v":"Background information - Change that affects scientific value of study"}]
[null,192,"Data collection, transfer or processing of identifiable participant information - Changes in arrangements or organisations involved (other than the addition of new participating organisations)",{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"N",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},{"$f":"$A$31","v":"(Y)"},{"$f":"$A$32","v":"N"},{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$32","v":"N"},"N","N",{"$f":"$A$30","v":"Y"},{"$f":"$A$43","v":"V"},{"$f":"$A$53","v":"N/A"},{"$f":"$A$64","v":"N/A"},{"$f":"$A$85","v":"N/A"},1,"Data collection, transfer or processing of identifiable participant information - Changes in arrangements or organisations involved (other than the addition of new participating organisations)",{"$f":"INDEX($AA$128:$AA$144,SMALL(IF(ISTEXT($AA$128:$AA$144),ROW($AA$1:$AA$17),\"\"),ROW(A2)))","v":"Data collection, transfer or processing of identifiable participant information - Changes in arrangements or organisations involved (other than the addition of new participating organisations)"}]
[null,65,"Endpoint/objective - Change to the endpoint or the main objective",{"$f":"$A$30","v":"Y"},{"$f":"$A$30","v":"Y"},"Y","N","N",{"$f":"$A$31","v":"(Y)"},"N","(Y)","N",{"$f":"$A$31","v":"(Y)"},"N","N","N",{"$f":"$A$31","v":"(Y)"},"N","N","N",{"$f":"$A$31","v":"(Y)"},{"$f":"$A$43","v":"V"},{"$f":"$A$47","v":"E.2.2"},{"$f":"$A$57","v":"E.3.2"},{"$f":"$A$86","v":"Part 1"},1,"Endpoint/objective - Change to the endpoint or the main objective",{"$f":"INDEX($AA$128:$AA$144,SMALL(IF(ISTEXT($AA$128:$AA$144),ROW($AA$1:$AA$17),\"\"),ROW(A3)))","v":"Endpoint/objective - Change to the endpoint or the main objective"}]
[null,147,"Extension to study duration that will have additional resource implications for participating organisations - Please specify in the free text below",{"$f":"$A$32","v":"N"},"N","Y","N","N","(Y)","N","(Y)","N","(Y)","N","N","N","(Y)","N","N","N","(Y)",{"$f":"$A$43","v":"V"},{"$f":"$A$53","v":"N/A"},{"$f":"$A$64","v":"N/A"},{"$f":"$A$85","v":"N/A"},1,"Extension to study duration that will have additional resource implications for participating organisations - Please specify in the free text below",{"$f":"INDEX($AA$128:$AA$144,SMALL(IF(ISTEXT($AA$128:$AA$144),ROW($AA$1:$AA$17),\"\"),ROW(A4)))","v":"Extension to study duration that will have additional resource implications for participating organisations - Please specify in the free text below"}]
[null,{"$f":"LEN(C132)","v":155},"Extension to study duration that will not have any additional resource implications for participating organisations - Please specify in the free text below","N","N","Y","N","N","(Y)","N","(Y)","N","(Y)","N","N","N","(Y)","N","N","N","(Y)",{"$f":"$A$40","v":"C"},{"$f":"$A$53","v":"N/A"},{"$f":"$A$64","v":"N/A"},{"$f":"$A$85","v":"N/A"},1,"Extension to study duration that will not have any additional resource implications for participating organisations - Please specify in the free text below",{"$f":"INDEX($AA$128:$AA$144,SMALL(IF(ISTEXT($AA$128:$AA$144),ROW($AA$1:$AA$17),\"\"),ROW(A5)))","v":"Extension to study duration that will not have any additional resource implications for participating organisations - Please specify in the free text below"}]
[null,98,"Inclusion/exclusion criteria - Minor change unlikely to affect safety or scientific value of study","N","N","Y","N","N","(Y)","N","(Y)","N","(Y)","N","N","N","(Y)","N","N","N","(Y)",{"$f":"$A$43","v":"V"},{"$f":"$A$53","v":"N/A"},{"$f":"$A$64","v":"N/A"},{"$f":"$A$85","v":"N/A"},1,"Inclusion/exclusion criteria - Minor change unlikely to affect safety or scientific value of study",{"$f":"INDEX($AA$128:$AA$144,SMALL(IF(ISTEXT($AA$128:$AA$144),ROW($AA$1:$AA$17),\"\"),ROW(A6)))","v":"Inclusion/exclusion criteria - Minor change unlikely to affect safety or scientific value of study"}]
[null,122,"Inclusion/exclusion criteria - Significant change (e.g. to age range) likely to affect safety or scientific value of study",{"$f":"$A$30","v":"Y"},{"$f":"$A$30","v":"Y"},"Y","N","N","(Y)","N","(Y)","N","(Y)","N","N","N","(Y)","N","N","N","(Y)",{"$f":"$A$43","v":"V"},{"$f":"$A$47","v":"E.2.2"},{"$f":"$A$59","v":"E.3.4"},{"$f":"$A$86","v":"Part 1"},1,"Inclusion/exclusion criteria - Significant change (e.g. to age range) likely to affect safety or scientific value of study",{"$f":"INDEX($AA$128:$AA$144,SMALL(IF(ISTEXT($AA$128:$AA$144),ROW($AA$1:$AA$17),\"\"),ROW(A7)))","v":"Inclusion/exclusion criteria - Significant change (e.g. to age range) likely to affect safety or scientific value of study"}]
[null,58,"New arm - Addition of a study arm or placebo/control group",{"$f":"$A$30","v":"Y"},{"$f":"$A$30","v":"Y"},"Y","N","N","(Y)","N","(Y)","N","(Y)","N","N","N","(Y)","N","N","N","(Y)",{"$f":"$A$43","v":"V"},{"$f":"$A$47","v":"E.2.2"},{"$f":"$A$59","v":"E.3.4"},{"$f":"$A$86","v":"Part 1"},1,"New arm - Addition of a study arm or placebo/control group",{"$f":"INDEX($AA$128:$AA$144,SMALL(IF(ISTEXT($AA$128:$AA$144),ROW($AA$1:$AA$17),\"\"),ROW(A8)))","v":"New arm - Addition of a study arm or placebo/control group"}]
[null,163,"Other minor change to study design that can be implemented within existing resource in place at participating organisations - Please specify in the free text below",{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},"Y","N","N","(Y)","N","(Y)","N","(Y)","N","N","N","(Y)","N","N","N","(Y)",{"$f":"$A$40","v":"C"},{"$f":"$A$53","v":"N/A"},{"$f":"$A$64","v":"N/A"},{"$f":"$A$85","v":"N/A"},1,"Other minor change to study design that can be implemented within existing resource in place at participating organisations - Please specify in the free text below",{"$f":"INDEX($AA$128:$AA$144,SMALL(IF(ISTEXT($AA$128:$AA$144),ROW($AA$1:$AA$17),\"\"),ROW(A9)))","v":"Other minor change to study design that can be implemented within existing resource in place at participating organisations - Please specify in the free text below"}]
[null,154,"Other minor change to study design that will have additional resource implications for participating organisations - Please specify in the free text below",{"$f":"$A$32","v":"N"},{"$f":"$A$32","v":"N"},"Y","N","N","(Y)","N","(Y)","N","(Y)","N","N","N","(Y)","N","N","N","(Y)",{"$f":"$A$43","v":"V"},{"$f":"$A$53","v":"N/A"},{"$f":"$A$64","v":"N/A"},{"$f":"$A$85","v":"N/A"},1,"Other minor change to study design that will have additional resource implications for participating organisations - Please specify in the free text below",{"$f":"INDEX($AA$128:$AA$144,SMALL(IF(ISTEXT($AA$128:$AA$144),ROW($AA$1:$AA$17),\"\"),ROW(A10)))","v":"Other minor change to study design that will have additional resource implications for participating organisations - Please specify in the free text below"}]
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["MHRA - Medicines",{"$f":"IF(AND('Amendment Tool'!$AE$60=1,'Amendment Tool'!$AF$60=1),1,0)","v":0},{"$f":"$B$3","v":0},{"$f":"COUNTIF('Amendment Tool'!$J$613:$J$622,'Menu Data'!$A$30)","v":0},{"$f":"COUNTIF('Amendment Tool'!$J$613:$J$622,'Menu Data'!$A$31)","v":0},{"$f":"COUNTIF('Amendment Tool'!$J$613:$J$622,'Menu Data'!$A$32)","v":0},{"$f":"IF(AND($D3:$F3=0),\"\",IF($C3=0,\"\",IF($D3>0,'Menu Data'!$A$30,'Menu Data'!$A$32)))","v":""},{"$f":"IF(AND($D3:$F3=0),\"\",IF($C3=0,\"\",IF($D3>0,'Menu Data'!$A$32,IF($E3>0,'Menu Data'!$A$30,'Menu Data'!$A$32))))","v":""}]
["MHRA - Devices",{"$f":"IF(AND('Amendment Tool'!$AE$64=1,'Amendment Tool'!$AF$64=1),1,0)","v":0},{"$f":"$B$4","v":0},{"$f":"COUNTIF('Amendment Tool'!$K$613:$K$622,'Menu Data'!$A$30)","v":0},{"$f":"COUNTIF('Amendment Tool'!$K$613:$K$622,'Menu Data'!$A$31)","v":0},{"$f":"COUNTIF('Amendment Tool'!$K$613:$K$622,'Menu Data'!$A$32)","v":0},{"$f":"IF(AND($D4:$F4=0),\"\",IF($C4=0,\"\",IF($D4>0,'Menu Data'!$A$30,'Menu Data'!$A$32)))","v":""},{"$f":"IF(AND($D4:$F4=0),\"\",IF($C4=0,\"\",IF($D4>0,'Menu Data'!$A$32,IF($E4>0,'Menu Data'!$A$30,'Menu Data'!$A$32))))","v":""}]
["ARSAC",{"$f":"IF(AND('Amendment Tool'!$AE$65=1,'Amendment Tool'!$AF$65=1),1,0)","v":0},{"$f":"$B$5","v":0},{"$f":"COUNTIF('Amendment Tool'!$L$613:$L$622,'Menu Data'!$A$30)","v":0},{"$f":"COUNTIF('Amendment Tool'!$L$613:$L$622,'Menu Data'!$A$31)","v":0},{"$f":"COUNTIF('Amendment Tool'!$L$613:$L$622,'Menu Data'!$A$32)","v":0},{"$f":"IF(AND($D5:$F5=0),\"\",IF($C5=0,\"\",IF($D5>0,'Menu Data'!$A$30,'Menu Data'!$A$32)))","v":""},{"$f":"IF(AND($D5:$F5=0),\"\",IF($C5=0,\"\",IF($D5>0,'Menu Data'!$A$32,IF($E5>0,'Menu Data'!$A$30,'Menu Data'!$A$32))))","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"New site amendment",null,null,"ALC amendment",null,null,null,"New ALC involvement",null,null,null,"HARP update"]
["Radiation Assurance",{"$f":"IF(AND('Amendment Tool'!$AE$67=1,'Amendment Tool'!$AF$67=1),1,0)","v":0},{"$f":"$B$6","v":0},{"$f":"COUNTIF('Amendment Tool'!$M$613:$M$622,'Menu Data'!$A$30)","v":0},{"$f":"COUNTIF('Amendment Tool'!$M$613:$M$622,'Menu Data'!$A$31)","v":0},{"$f":"COUNTIF('Amendment Tool'!$M$613:$M$622,'Menu Data'!$A$32)","v":0},{"$f":"IF(AND($D6:$F6=0),\"\",IF($C6=0,\"\",IF($D6>0,'Menu Data'!$A$30,'Menu Data'!$A$32)))","v":""},{"$f":"IF(AND($D6:$F6=0),\"\",IF($C6=0,\"\",IF($D6>0,'Menu Data'!$A$32,IF($E6>0,'Menu Data'!$A$30,'Menu Data'!$A$32))))","v":""},null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,null,"England/Wales","Scotland","N. Ireland","England","Wales","Scotland","N. Ireland","England","Wales","Scotland","N. Ireland"]
["UKSW",{"$f":"'Amendment Tool'!$AJ$143","v":1},{"$f":"$B$7","v":1},{"$f":"COUNTIF('Amendment Tool'!$N$613:$N$622,'Menu Data'!$A$30)","v":1},{"$f":"COUNTIF('Amendment Tool'!$N$613:$N$622,'Menu Data'!$A$31)","v":2},{"$f":"COUNTIF('Amendment Tool'!$N$613:$N$622,'Menu Data'!$A$32)","v":7},{"$f":"IF(AND($D7:$F7=0),\"\",IF($C7=0,\"\",IF($D7>0,'Menu Data'!$A$30,'Menu Data'!$A$32)))","v":"Y"},{"$f":"IF(AND($D7:$F7=0),\"\",IF($C7=0,\"\",IF($D7>0,'Menu Data'!$A$32,IF($E7>0,'Menu Data'!$A$30,'Menu Data'!$A$32))))","v":"N"},null,null,{"$f":"IF('Amendment Tool'!AH102=0,'Menu Data'!$A$32,IF(Arrays!$C$2=0,'Menu Data'!$A$32,VLOOKUP('Amendment Tool'!AH102,INDIRECT(CONCATENATE(SUBSTITUTE('Amendment Tool'!AH101,\" \",\"_\"),\"Full\")),2)))","v":"N"},{"$f":"IF('Amendment Tool'!AH102=0,'Menu Data'!$A$32,IF(Arrays!$C$3=0,'Menu Data'!$A$32,VLOOKUP('Amendment Tool'!AH102,INDIRECT(CONCATENATE(SUBSTITUTE('Amendment Tool'!AH101,\" \",\"_\"),\"Full\")),3)))","v":"N"},{"$f":"IF('Amendment Tool'!AH102=0,'Menu 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["REC (MCA)",{"$f":"IF(AND('Amendment Tool'!$AE$60=1,'Amendment Tool'!$AF$60=1),0,IF(AND('Amendment Tool'!$AE$68=1,'Amendment Tool'!$AF$68=1),1,0))","v":0},{"$f":"IF($B$8=0,0,IF(OR('Amendment Tool'!$AJ$144:$AK$587=TRUE),1,0))","v":0},{"$f":"COUNTIF('Amendment Tool'!$O$613:$O$622,'Menu Data'!$A$30)","v":0},{"$f":"COUNTIF('Amendment Tool'!$O$613:$O$622,'Menu Data'!$A$31)","v":0},{"$f":"COUNTIF('Amendment Tool'!$O$613:$O$622,'Menu Data'!$A$32)","v":0},{"$f":"IF(AND($D8:$F8=0),\"\",IF($C8=0,\"\",IF($D8>0,'Menu Data'!$A$30,'Menu Data'!$A$32)))","v":""},{"$f":"IF(AND($D8:$F8=0),\"\",IF($C8=0,\"\",IF($D8>0,'Menu Data'!$A$32,IF($E8>0,'Menu Data'!$A$30,'Menu Data'!$A$32))))","v":""},null,{"$f":"IF(AND('Amendment Tool'!AJ144:AM146=FALSE),\"\",IF('Amendment Tool'!AH102=0,\"\",IF(AND('Amendment Tool'!$AE$95=1,'Amendment Tool'!$AF$91=5),'Menu Data'!$A$24,IF(AND(L8='Menu Data'!$A$30,K8<>'Menu Data'!$A$30),'Menu Data'!$A$23,IF(OR(K8='Menu Data'!$A$30,Q8='Menu Data'!$A$30,U8='Menu Data'!$A$30,Y8='Menu 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["CAG",{"$f":"IF(AND('Amendment Tool'!$AE$69=1,'Amendment Tool'!$AF$69=1),1,0)","v":0},{"$f":"IF($B$9=0,0,IF(OR('Amendment Tool'!$AJ$144:$AK$587=TRUE),1,0))","v":0},{"$f":"COUNTIF('Amendment Tool'!$P$613:$P$622,'Menu Data'!$A$30)","v":0},{"$f":"COUNTIF('Amendment Tool'!$P$613:$P$622,'Menu Data'!$A$31)","v":0},{"$f":"COUNTIF('Amendment Tool'!$P$613:$P$622,'Menu Data'!$A$32)","v":0},{"$f":"IF(AND($D9:$F9=0),\"\",IF($C9=0,\"\",IF($D9>0,'Menu Data'!$A$30,'Menu Data'!$A$32)))","v":""},{"$f":"IF(AND($D9:$F9=0),\"\",IF($C9=0,\"\",IF($D9>0,'Menu Data'!$A$32,IF($E9>0,'Menu Data'!$A$30,'Menu Data'!$A$32))))","v":""}]
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["Category",null,{"$f":"$C$7","v":1}]
[null,null,null,null,null,null,null,null,null,{"$f":"'Amendment Tool'!C198","v":"Change 3"}]
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[]
["Area of Amendment","Based on amdt info selection","Applicable area list","Clean area list (array function)","Applicable area","Specific options area prefix","Specific options area target","Specific options area"]
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[{"$f":"'Menu Data'!$A3","v":"Confidential patient information arrangements "},{"$f":"IF(AND('Amendment Tool'!$AG$91=1,'Amendment Tool'!$AF$91<>4),0,IF(OR($B$9=1,$B$13=1,$B$17=1),1,0))","v":0},0,{"$f":"INDEX($C$31:$C$48,SMALL(IF(ISTEXT($C$31:$C$48),ROW($D$1:$D$18),\"\"),ROW(A2)))","v":"Other "},{"$f":"CONCATENATE(\"Area_\",$E$31)","v":"Area_9"},"Confidential_patient_information_arrangements_",{"$f":"'Menu Data'!$Z$11","v":9},"Confidential_patient_information_arrangements_9",null,"Type","REC/MoDREC","MHRA Meds","MHRA Devs","ARSAC","Radiation","UKSW","REC (MCA)","CAG","HMPPS","HRA HCRW","REC (AWIA)","PBPP","SPS (RAEC)","NHS P","HSC REC","HSC DG","Prisons","HSC P","Category","Annex 2 Type","Annex 2 Reason","CWoW"]
[{"$f":"'Menu Data'!$A4","v":"CTIMP documents "},0,0,{"$f":"INDEX($C$31:$C$48,SMALL(IF(ISTEXT($C$31:$C$48),ROW($D$1:$D$18),\"\"),ROW(A3)))","v":"Participant Procedures "},null,"CTIMP_documents_",0,"CTIMP_documents_0"]
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[]
[]
[null,null,null,null,null,null,null,null,null,{"$f":"'Amendment Tool'!C345","v":"Change 6"}]
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[null,null,null,null,null,null,null,null,null,"Type","REC/MoDREC","MHRA Meds","MHRA Devs","ARSAC","Radiation","UKSW","REC (MCA)","CAG","HMPPS","HRA HCRW","REC (AWIA)","PBPP","SPS (RAEC)","NHS P","HSC REC","HSC DG","Prisons","HSC P","Category","Annex 2 Type","Annex 2 Reason","CWoW"]
[]
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