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SOP TITLES With Table of contents
1 Preparing Standard Operating Procedures (SOPs): Writing, Reviewing, Distributing & Amending SOPs for the Institutional Review Board (IRB), TMC
2 Constitution of Institutional Review Board (IRB), TMC
3 Management of Research Study Submissions
4 Initial Review of Submitted Protocol
  Expedited Review of Submitted Protocol/Documents
  Exemption from the Review for Research Projects
5 Agenda Preparation, Meeting Procedures and Recording of Minutes
6 Review of Amended protocol/ Protocol related documents
7 Continuing review of study Protocols
8 Review of Protocol Deviation/Non-Compliance / Violation / Waiver
9 Review of Serious Adverse Events (SAE) Reports
10 Maintenance of Active Project Files, Archival / Disposal of closed files and Retrieval of documents
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12 Review of study completion reports
13 Management of Premature Termination / Suspension /Discontinuation of the study
14 Review of Request for waiver of Written Informed Consent
15 Site Monitoring
16 Dealing with participants/patients requests and complaints
17 Reviewing Research Protocols Involving Vulnerable Populations

 

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