SCART: For Investigators

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. Return both documents to the SCART Trial Office.

• Investigator Registration Form [.pdf]
• Site Staff Registration Form [.pdf]

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 SCART Trial Office.

• Protocol [.pdf]
• Patient Information Sheet [.pdf]
• Informed Consent Form [.pdf]
• GP Letter [.pdf]
• HIV Physician Letter [.pdf]
• Release of Medical Information Form [.pdf]
• Patient ID card [.pdf]
• Patient Diary OD Dose [.pdf]
• Patient Diary BD Dose [.pdf]

Version Control Lists

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

• Version Control Log [.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.

• Amendment 1 Dec-2011 [opens a new page]
• Amendment 2 Mar-2012 [opens a new page]
• Amendment 3 Arp-2012 [opens a new page]
• Amendment 4 Oct-2012 [opens a new page]
• Amendment 5 Feb-2013 [opens a new page]
• Amendment 6 Oct-2013 [opens a new page]
• Amendment 7 Dec-2013 [opens a new page]
• Amendment 8 Dec-2014 [opens a new page]
• Amendment 9 Apr-2015 [opens a new page]
• Amendment 10 Jun-2015 [opens a new page]
• Amendemnt 11 Dec-2015 [opens a new page]
• Amendment 12 Mar-2016 [opens a new page]

Case Report Form

• Case Report Forms
  • Cardiac Assesment Form 07-May-2015 [.pdf]
  • Adverse Events 07-May-2015 [.pdf]
  • Concomitant Medications 07-May-2015 [.pdf]
  • Death Form 07-May-2015 [.pdf]
  • Deviation Form 07-May-2015 [.pdf]
  • Patient Withdrawal Form 07-May-2015[.pdf]
  • Treatment Dsicontinuation Form 07-May-2015 [.pdf]
  • Ophthalmologicac Assesment Form 07-May-2015 [.pdf]
  • Pregancy Notification Form 07-May-2015 [.pdf]
  • Cycle 1 Day 22 Cycle 2 Day 1 Assesment Form 07-May-2015 [.pdf]
  • Cycle 1 Dosing Compliance Form 07-May-2015 [.pdf]
  • Cycle 1 Pre-Treatment Day 1 Assesment Form 07-May-2015 [.pdf]
  • Cycle 1 Treatment Continuation Assesment Form 07-May-2015 [.pdf]
  • Cycle 1 Treatment Continuation Dosing Compliance Form 07-May-2015 [.pdf]
  • Cycle 2 Day 22 Cycle 3 Day 1 Assesment Form 07-May-2015 [.pdf]
  • Cycle 2 Dosing Compliance Form 07-May-2015 [.pdf]
  • Treatment Continuation Cycle 2 Assessment Form 07-May-2015 [.pdf]
  • Treatment Continuation Cycle 2 Dosing Compliance Form 07-May-2015 [.pdf]
  • Cycle 3 Day 22, Cycle 4 Day 1 Assessment Form 07-May-2015 [.pdf]
  • Cycle 3 Dosing Compliance Assesment Form 07-May-2015 [.pdf]
  • Treatment Continuation Cycle 3 Assessment Form 07-May-2015 [.pdf]
  • Treatment Continuation Cycle 3 Dosing Compliance Form 07-May-2015 [.pdf]
  • Cycle 4 Day 22, Cycle 5 Day 1 Assessment Form 07-May-2015 [.pdf]
  • Cycle 4 Dosing Compliance Form 07-May-2015 [.pdf]
  • Treatment Continuation Form Cycle 4 Assessment Form 07-May-2015 [.pdf]
  • Treatment Continuation Cycle 4 Dosing Compliance Form 07-May-2015 [.pdf]
  • Cycle 5 Day 22, Cycle 6 Day 1 Assessment Form 07-May-2015 [.pdf]
  • Cycle 5 Dosing Compliance Form 07-May-2015 [.pdf]
  • Treatment Continuation Cycle 5 Assessment Form 07-May-2015 [.pdf]
  • Treatment Continuation Cycle 5 Dosing Compliance Form 07-May-2015 [.pdf]
    
  • Cycle 6 Day 22 Assesment Form 07-May-2015 [.pdf]
  • Cycle 6 Dosing Compliance Form 07-May-2015 [.pdf]
  • Treatment Continuation Cycle 6 Assessment Form 07-May-2015 [.pdf]
  • Treatment Contination Cycle 6 Dosing Compliance Form 07-May-2015 [.pdf]
  • Follow Up 30 Day Post Discontinuation of Treatment Follow up Form 7-May-2015 [.pdf]
  • Heamatology Clinical Chemistry Assessments Form 07-May-2015 [.pdf]
  • Cardiac Assessment Form 07-May-2015 [.pdf]
  • Post Treatment Adverse Event Follow-Up Form 07-May-2015 [.pdf]
  • Post Treatment 12 Weekly Assessment Form 07-May-2015 [.pdf]
  • Eligibility Form 07-May-2015 [.pdf]
  • Screening Assessment Form 07-May-2015 [.pdf]
  • Registration From 07-May-2015 [.pdf]
  • Registration Confirmation Fax Template 2 [.pdf]

Guidelines

• CRF Completion Guidelines [.pdf]
• SAE Form Completion Guidelines [.pdf]

Other Trial Documents

• Pharmacy Manual [.pdf]
• Nursing Checklists
  • Phase II
    • 1. SCART_NC_Phase_II_Screening_v1.0_vd04_Apr_12 [.pdf]
    • 2. SCART_NC_Phase_II_C1D1_PreT_v1.0_vd26_Apr_12 [.pdf]
    • 3. SCART_NC_Phase_II_C1D22-C2D1_v1.0_vd26_Apr_12 [.pdf]
    • 4. SCART_NC_Phase II_C2D22-C3D1_v1.0_vd26_Apr_12 [.pdf]
    • 5. SCART_NC_Phase_II_C3D22-C4D1_v1.0_vd26_Apr_12 [.pdf]
    • 6. SCART_NC_Phase_II_C4D22-C5D1_v1.0_vd26_Apr_12 [.pdf]
    • 7. SCART_NC_Phase_II_C5D22-C6D1_v1.0_vd26_Apr_12 [.pdf]
    • 8. SCART_NC_Phase_II_C6D22_v1.0_vd26_Apr_12 [.pdf]
    • 9. SCART_NC_Off_Study_v2.0_vd29_Mar_12 [.pdf] 
    • 10. SCART_NC_30_Day_FUP_v2.0_vd04_Apr_12 [.pdf]
    • 11. SCART_NC_12_weekly_PT_FUP_v1.0_vd16_Mar_12 [.pdf]
    • 12. SCART_NC_TC_C1D22-C2D1_v2.0_vd29_Mar_12 [.pdf]
    • 13. SCART_NC_TC_C2D22-C3D1_v2.0_vd29_Mar_12 [.pdf]
    • 14. SCART_NC_TC_C3D22-C4D1_v2.0_vd29_Mar_12 [.pdf]
    • 15. SCART_NC_TC_C4D22-C5D1_v2.0_vd29_Mar_12 [.pdf]
    • 16. SCART_NC_TC_C5D22-C6D1_v2.0_vd29_Mar_12 [.pdf]
    • 17. SCART_NC_TC_C6D22_v2.0_vd29_Mar_12 [.pdf]
    • 18. SCART_NC_AE_Form_v2.0_vd02_Apr_12 [.pdf]
    • 19. SCART_NC_Con_Med_Form_v1.0_vd16_Mar_12 [.pdf]
    • 20. SCART_NC_Clin_Exam_Form_v1.0_vd16_Mar_12 [.pdf]
    • 21. SCART_NC_Clin_Photo_Form_v2.0_vd04_Apr_12 [.pdf]
    • 22. SCART_NC_Current_HAART_v1.0_vd16_Mar_12 [.pdf]
    • 23. SCART_NC_Medical_History_v1.0_vd16_Mar_12 [.pdf]
    • 24. SCART_NC_HIV1_CD4_v1.0_vd16_Mar_12 [.pdf]
    • 25. SCART_NC_ECG_Form_v1.0_vd16_Mar_12 [.pdf]
    • 26. SCART_NC_Ophth_Assess_Form_v1.0_vd16_Mar_12 [.pdf]
    • 27. SCART_NC_Previous_KS_treatment_v1.0_vd16_Mar_12 [.pdf]
• Nursing Checklists Version Control Log [.pdf]

To date there are no publications for this trial.

To date there is no news or events for this trial.

Contact Details

Chief Investigator
Professor Penella Woll
Professor of Medical Oncology
University of Sheffield

SCART Trial Office
Trial Coordinator:                                          Laura Crack
Trial Administrator:                                       Christina Russell
Trial Monitor:                                                 Amen Zafar
Trial Management Team Leader:                 Jayne Doran

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

Enquiries
Tel: +44 (0) 121 414 6754
Fax: +44 (0) 121 414 3529
Email: SCART@contacts.bham.ac.uk

Trial Entry
Telephone: +44 (0) 121 414 6754              (9.00 am till 5.00 pm Monday to Friday)

Serious Adverse Event Reporting

Fax: 0121 414 3529 or 0121 414 3700

 Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust

CRCTU Home Page
http://www.birmingham.ac.uk/crctu