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SOP for Research Involving Human Subject

NoTitle of SOPFile
1 Writing, Reviewing, Distributing and Amending Standard Operating Procedures for Ethics Committees Download
2 Preparation of Guidelines Download
3 Constituting an MRIN EC Download
4 Confidentiality / Conflict of Interest Agreements Download
5 Training Personnel and MRIN EC Members Download
6 Selection of Independent Consultants Download
7 Management of Protocol Submissions Download
8 Use of Study Assessment Forms Download
9 Expedited Review Download
10 Initial Review of Submitted Protocols Download
11 Review of New Medical Device Studies Download
12 Review of Resubmitted Protocols Download
13 Review of Protocol Amendments Download
14 Continuing Review of Study Protocols Download
15 Review of Final Reports Download
16 Intervention in Protocol Deviation /Non-Compliance/Violation Intervention Download
17 Response to Participants' Requests Download
18 Management of Study Termination Download
19 Review of Serious Adverse Events (SAE)/SUSAR Reports Download
20 Site Monitoring Visit Download
21 Agenda Preparation, Meeting Procedures and Minutes Download
22 Emergency Meeting Download
23 Communication Records Download
24 Maintenance of Active Study Files Download
25 Archive and Retrieval of Documents Download
26 Maintaining Confidentiality of MRIN EC Documents  Download
27 Audit and Inspection of the MRIN EC Download