Institutional Ethics Committee (IEC)

STANDARD OPREATING PROCEDURE IEC

• IEC Member Name
• SOP with Rules & Regulation to follow

Common Form for Ethics Committee Review

1. Annexure 1 – Confidentiality Agreement Form for IEC Members
2. Annexure 2 -Conflict of Interest Agreement Form for IEC Members
3. Annexure 3-Request Letter by Dean (Research) to the Members
4. Annexure 4-Consent Letter by Members of IEC
5. Annexure 5 (B)-Application Form for Clinical Trials
6. Annexure 6-Format for Curriculum Vitae of Investigators
7. Annexure 8-Acknowledgment Letter
8. Annexure 9-Initial Checklist to Verify Completeness of Documents Submitted
9. Annexure 10-Application Form for Expedited Review
10. Annexure 11-Application Form for Exemption from Review
11. Annexure 12-Project Extension Form
12. Annexure 13-Continuing Review
13. Annexure 14-Application-Notification Form for Amendments
14. Annexure 15-Protocol Violation-Deviation Reporting Form (Reporting by Case)
15. Annexure 16 (A)Serious Adverse Event Reporting Format (Biomedical Health Research)
16. Annexure 16 (B) Serious Adverse Event Reporting Format (Clinical Trials)
17. Annexure 17 Premature Termination-Suspension Discontinuation Report Format
18. Annexure 18 Study Completion=Final Report Format
19. Annexure 19 Initial Review Form for Multicentric Research
20. Annexure 20 Review Letter no. of IEC-
21. Annexure 21 Format for Approval of Ethics Committee
22. Annexure 22 Factor (F) for Calculating the Amount of Compensation