Standard Operating Procedures

 SOP – Introductory Page

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

7. Expedited review, revised

8. Initial Review of Project Proposal

9. Vulnerable Population

10.  Audio Video Consent

11. Review of resubmitted protocols

12. Review of Protocol Amendments

13. Continuing review of study protocols

14.  Review of Final Report

15. Review of Serious Adverse Event (SAE) Reports

16. Intervention in Protocol deviation

17. Response to Research Participants Requests

18. Managment of Study Termination

19. Site Monitoring visit

20. Agenda Preparation meeting procedures and minutes

21.  Maintenance of Active Study Files

22. Archives and Retrieval of Documents

23. Maintaining Confidentiality of IEC Documents

24. Audit and Inspection of the IEC