Standard Operating Procedures

Signed pages of SOP Version 6.1 dated 26.02.2021

01) Writing Reviewing

02) Constituting an Ethics Committee

03) Confidentiality

04) Training Personnel & Ethics Committe Members

05) Selection of Individual Consultants

06) Templates for protocol & Other submissions

07) Vulnerable Population

08) Audio Video Consent

09) Management of Protocol Submission

10) Exempt from Ethical Review

11) Expedited review

12) Initial Review of Project Protocol

13) Review of resubmitted protocols

14) Review of Protocol Amendments

15) Continuing review report and Request for extension of study protocols

16) Review of Completion or Final Report

17) Management of Study Termination or Suspension or Discontinuation

18) Serious Adverse Event (SAE) Reports SOP

19) Intervention in Protocol deviation

20) Response to Research Participants Requests

21) Site Monitoring visit

22) Agenda Preparation meeting procedures and minutes

23) Maintenance of Active Study Files

24) Archives and Retrieval of Documents

25) Maintaining Confidentiality of IEC Documents

26) Audit and Inspection of the IEC

27) Review procedures during Emergency