Standard Operating Procedures


 

 

 

 

 

 

 

 




1. Writing, Reviewing, Distributing and Amending SOPs

2. Constituting an Ethics Committee

3. Confidentiality/Conflict of Interest Agreement

4. Training Personnel and Ethics Committee Members

5. Selection and Responsibilities of Independent Consultants (IC)

6. Management of Protocol Submission- Version 1

6. Management of Protocol Submission- Version 1.1

7. Expedited review, revised

8. Initial Review of Project Proposal-Version 1

8. Initial Review of Project Proposal-Version 1.1

9. Community Members meeting

10. Vulnerable Population

11. Intervention in Protocol Deviation/Non-compliance/Violation

12. Review of Serious Adverse Event (SAE) Reports

13. Agenda Preparation, Meeting Procedures and Minutes

14. Maintenance of Active Study Files

15. Archival and Retrieval of Documents

16. Maintaining Confidentiality of IEC Documents

17. Review of Resubmitted Protocols

18. Review of Protocol Amendments

19. Continuing Review of Study Protocol

20. Review of Final Report

21. Response to Research Participants’ Requests

22. Management of Study Termination

23. Site Monitoring Visit

24. Audit and Inspection of the IEC