TORCH

If there is a change of staff working on the trial please print off and complete the relevant registration form below. Please also ensure that the Signature and Delegation Log is updated. 

• Investigator Registration Form [.pdf]
• Site Staff Registration Form [.pdf]
• Delegation Log [.doc]

Links to the current protocol, Patient Information Sheet, Informed Consent Form are provided below. If there has been a recent amendment to the trial please ensure you have R&D approval before using these documents.

Other documents (e.g. Amendments, Case Report Form, Serious Adverse Event Form, Guidelines, GP Letter, Release of Medical Information Form etc) can be found by clicking on the other menu items below. If you cannot find what you are looking for please contact the TORCH Trial Office.

Protocol

• Protocol [.pdf]
• Trial Summary [.pdf]

Patient Documents

• Patient Information Sheet - AZD2014 alone [.pdf]
• Informed Consent Form - AZD2014 alone [.pdf]
• Patient information sheet AZD2014+Rituximab [.pdf]
• Informed Consent form AZD2014+Rituximab [.pdf]
• GP Letter  [.pdf]
• Release of Medical Information form [.pdf]
• Patient Diary [.pdf]
• Patient ID card [.pdf]

Version Control Lists

The version numbers and dates of all documents used for the trial are captured on a Version Control List. Links to the Version Control Lists used in this trial are below in reverse date order.

Current

• Version Control Checklist - v6.0 29-Sep-2016 Investigator Site Folder [.pdf]
• Version Control Checklist - v5.0 29-Sep-2016 Pharmacy Folder [.pdf]

Previous

• Version Control Checklist - v5.0 16-Mar-2016 Investigator Site Folder [.pdf]
• Version Control Checklist - v4.0 29-Jan-2016 Investigator Site Folder [.pdf]
• Version Control Checklist - v3.0 16-Nov-2015 Investigator Site Folder [.pdf]
• Version Control Checklist - v2.0 13-Nov-2015 Investigator Site Folder [.pdf]
• Version Control Checklist - v1.0 05-Oct-2015 Investigator Site Folder [.pdf]
• Version Control Checklist - v3.0 07-Jun-2016 Pharmacy Folder [.pdf]
• Version Control Checklist - v2.0 12-Nov-2015 Pharmacy Folder [.pdf]
• Version Control Checklist - v1.0 05-Oct-2015 Pharmacy Folder [.pdf]

Amendments

Below is a link to a document which lists all of the substantial protocol amendments which have been made for this trial. The folders below contain the relevant amended documentation and approval letters. Please ensure that you have R&D approval (if applicable) before using the latest versions of these documents.

• Amendments (opens new page)

Guidelines

• CRF Completion Guidelines  [.pdf]
• SAE Form Completion Guidelines  [.pdf]
• Informed Consent Guidelines [.pdf]
• PET Imaging Manual  [.pdf]
• Sample collection Manual  [.pdf]

Other Trial Documents

• Pharmacy Manual [.pdf]
• Drug request form [.pdf]

Case Report Forms

• Registration Form [.pdf]
• Eligibility Form [.pdf]
• Screening Form [.pdf]
• AZD2014 Treatment Form - Cycle 1 [.pdf]
• AZD2014 Treatment Form - Cycle 2 [.pdf]
• AZD2014 Treatment Form - Cycle 3 [.pdf]
• AZD2014 Treatment Form - Cycle 4 [.pdf]
• AZD2014 Treatment Form - Cycle 5 [.pdf]
• AZD2014 Treatment Form - Cycle 6 [.pdf]
• AZD2014 Treatment Form - Additional Cycles [.pdf]
• Combination Treatment Form cycle 1 [.pdf]
• Combination Treatment Form cycle 2 [.pdf]
• Combination Treatment Form cycle 3 [.pdf]
• Combination Treatment Form cycle 4 [.pdf]
• Combination Treatment Form cycle 5 [.pdf]
• Combination Treatment Form cycle 6 [.pdf]
• End of Treatment Form [.pdf]
• 30 days post treatment Form [.pdf]
• Follow-up Form [.pdf]
• Concomitant Medication Form [.pdf]
• Adverse Events Form [.pdf]
• Treatment Discontinuation Form [.pdf]
• Progressive Disease Form [.pdf]
• Withdrawal Form [.pdf]
• Notification of Death Form [.pdf]
• Deviation Form [.pdf]

All CRFs [.zip]

• SAE Form [.pdf]
• SAE Fax Cover Sheet [.pdf]

 

• Saliva Sample collection Form [.pdf]
• Blood Sample Collection Form [.pdf]
• Tissue Sample Collection Form [.pdf]

To date there are no publications for this trial.

Last NewsLetter (Autumn 2016) [.pdf]
New year 2016  [.pdf]

Previous newsletters [.zip]

Chief Investigator
Dr Graham Collins
Oxford Cancer and Haematology Centre, Churchill Hospital, Old Road, Oxford, OX3 7EJ

Tel:      +44 (0)1865 235886

TORCH Trial Office
Trial Coordinator:                      Godwill Iheagwaram       
                             
Trial Monitor:                                    Kavita Mistry
Trial Management Team Leader:    Shamyla Siddique
Trial Statistician:                              Anesh Panchal

Cancer Research UK Clinical Trials Unit (CRCTU)
Institute of Cancer and Genomic Sciences
University of Birmingham
Edgbaston
Birmingham
B15 2TT

Enquiries
Telephone: +44 (0)121 415 9175
Fax:             +44 (0)121 414 6061
Email:         torch@trials.bham.ac.uk

Trial Entry
Telephone: +44 (0) 121 415 9175              (9.00 am till 5.00 pm Monday to Friday)

Serious Adverse Event Reporting
Fax: +44 (0)121 414 6061

Sponsor

University of Birmingham