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, Roles and responsibilities of each member of IEC

Annexure 3.1, Rights & Responsibilities of Research Participants [English]

Annexure 3.2, 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, Site Monitoring Report - Non regulated project

Annexure 11, SAE Report Checklist

Annexure 12, WHO Tool for Causality Assessment

Annexure 13, Naranjo ADR Probability Scale

Annexure 14, Format of IEC Report to CDSCO in case of SAE

Annexure 15, Compensation Formula, SAE, Death

Annexure 16, Compensation Formula, SAE, Injury other than Death

Annexure 17, Check-list for review of research proposals

Annexure 18, Contents of research proposal

Annexure 19, Check list for informed consent

Annexure 20, Apendix XI - Schedule Y

Annexure 21, Appendix XII - Schedule Y