Annexures
- Annexure 1, IEC Member's List [June, 2020]
- Annexure 2, Confidentiality & COI agreement for members
- Annexure 2.1, Format for Declaration of Conflict of Interest for IEC Members or Investigators
- Annexure 3, Rights & Responsibilities of Research Participants [English]
- Annexure 3.1, Rights & Responsibilities of Research Participants [Gujarati]
- Annexure 5, Application Format for Industry or Government Initiated Full Committee Review Project
- Annexure 5.1, Participant Information Sheet [English]
- Annexure 5.2, Participant Information Sheet [Gujarati]
- Annexure 5.3, Informed Consent Form [English]
- Annexure 5.4, Informed Consent Form [Gujarati]
- Annexure 7, Project submission check lists for investigators
- Annexure 8, Format of response to query letter by Investigator
- Annexure 9, Format of approval letter by Institutional Ethics Committee
- Annexure 10, Site Monitoring Report - Regulated Trial
- Annexure 10.1, AV Consenting Monitoring Report - Regulated Trial
- Annexure 11, WHO Tool for Causality Assessment
- Annexure 12, Naranjo ADR Probability Scale
- Annexure 13, Format of IEC Report to CDSCO in case of SAE
- Annexure 14, Compensation Formula, SAE, Death
- Annexure 15, Compensation Formula, SAE, Injury other than Death
- Annexure 16, Checklist, Informed Consent Document
- Annexure 17, Checklist, Review of CTA
- Annexure 18, Checklist, Review of CT Proposal
- Annexure 19, Checklist, Review of SAE
- Annexure 20, Apendix XI - Schedule Y
- Annexure 21, Appendix XII - Schedule Y
- Annexure 22, Research Participant Interview Guide [English]
- Annexure 23, Research Participant Interview Guide [Gujarati]
- Annexure 24, Protocol deviation, violation Reivew
- Annexure 25, Application format and Proforma for Academic Clinical Trial
- Annexure 26, Format of undertaking by Principal Investigator, Academic Clinical Trials
