Annexures

 

 

 

Annexure 1, IEC Member's List

 

Annexure 1-A, IEC-2 Member's List

 

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