SOP for Involving Animal Subject
No
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02
03
04
05
06
07
08
09
10
11
12
13
14
15
16
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19
20
21
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27
Title
Writing, Reviewing, Distributing and Amending Standard Operating Procedures
Preparation of Guidelines
Constituting an Ethics Committe
Confidentiality / Conflict of Interest Agreement
Training Personnel and 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
Management of Progress Report
Review of Final Reports
Intervention in Protocol Deviation /Non-Compliance/Violation
Response to Animals Welfare
Management of Study Termination
Review of Serious Adverse Events (SAE)/Suspected Unexpected Serious Adverse Event (SUSAR) Reports
Site Monitoring Visit ( Post Approval Monitoring & Facilities Inspection and Program Review )
Agenda Preparation, Meeting Procedures and Minutes
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