Annexures
Annexure 1, IEC Member's List [June, 2019]
Annexure 1-A, IEC-2 Member's List [May, 2018]
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 4, Application format for investigator initiated full committee or exempt review project
Annexure 4.1, Protocol format for investigator initiated full committee or exempt review project
Annexure 4.2, Participant Information Sheet [English]
Annexure 4.3, Participant Information Sheet [Gujarati]
Annexure 4.4, Informed Consent Form [English]
Annexure 4.5, Informed Consent Form [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 6, Application format for investigator initiated case reports reveiw
Annexure 6.1, Protocol format for investigator initiated case reports reveiw
Annexure 6.2, Case report Consent or Assent Form [English]
Annexure 6.3, Case report Consent or Assent 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