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.
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]