SOP for Involving Human Subject
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Title
Introduction and Approval of SOPS
Writing, Reviewing, Distributing and Amending Standard Operating Procedures for Ethics Committees
Preparation of Guidelines
Constituting an MRIN EC
Confidentiality / Conflict of Interest Agreements
Training Personnel and MRIN EC Members
Selection of Independent Consultants
Management of Protocol Submissions
Use of Study Assessment Forms
Expedited Review
Initial Review of Submitted Protocols
Review of New Medical Device Studies
Review of Resubmitted Protocols
Review of Protocol Amendments
Continuing Review of Study Protocols
Review of Final Reports
Intervention in Protocol Deviation /Non-Compliance/Violation Intervention
Response to Participants' Requests
Management of Study Termination
Review of Serious Adverse Events (SAE)/SUSAR Reports
Site Monitoring Visit
Meeting Procedures
Emergency Meeting
Communication Records
Maintenance of Active Study Files
Archive and Retrieval of Documents
Maintaining Confidentiality of MRIN EC Documents
Audit and Inspection of the MRIN EC
Glossaries 2024