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Tagore Medical College & Hospital

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SOP OF IRC

Institutional Ethics Committee Standard Operating Procedures

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

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Tagore Medical College and Hospital
Rathinamangalam, Melakottaiyur,
Chennai 600 127.

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

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