Tagore Medical College & Hospital

SOP OF IRC

SOP No.	Standard Operating Procedure
1	Composition, procedures for new induction and resignation of members
2	Agenda Preparation, Meeting Procedures and Recording of Minutes
3	Receipt, review and decision making of proposals
4	Continuing Review of Study Protocols
5	Expedited Review
6	Exemption from the Ethics Review for Research Projects
7	Reviewing proposals involving vulnerable Populations
8	Conduct of Emergency Meeting
9	Review of Resubmitted Protocols
10	Review of protocol amendments
11	Review of Study Completion Reports
12	Review of Serious Adverse Events (SAE) Reports and Unexpected Adverse Events (UAE)
13	Confidentiality / Conflict of Interest Agreements
14	Audio Visual (AV) Recording of Informed Consent Process
15	Constituting SAE Subcommittee
16	Protocol Deviation/Violation
17	Selection and Responsibilities of Subject expert
18	Maintenance of Active Project Files
19	Management of Premature Termination /Suspension / Discontinuation of the study /Withdrawal of study before site initiation
20	Site Monitoring Visit
21	Procedure for Research Participant’s Request or Complaint
22	Archiving and Retrieving Documents
23	Preparation of Standard Operating Procedures (SOPs) for Institutional Ethics Committee (IEC)
24	Annexure, templates and forms

Phone: +91 44 30101111, +91 44 22299555
Fax: +91 44 30101100
Email ID: tagoremch@gmail.com
Emergency contact number : 044-22299500

INFORMATION UNDER MSR CLAUSE B.1.11