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Department of Biotechnology
Ministry of Science & Technology
Government of India
Guidance for IEC
CDSA with support from experts has developed a "Guidance Document for Institutional Ethics Committee (IEC) that Review Clinical Trials on Human Participants". This document provides guidance for functioning of an institutional ethics committee involving review of study protocol of a regulated clinical trial. The document could also be a useful resource for those who plan to involve, start an IEC and/or understand what an IEC does.
This document provides general guidance but does not define regulatory expectations in this area. This guidance document should not be regarded as a definitive interpretation of any Act or Guidelines. Anyone in doubt should refer to applicable rules and regulations, and guidelines. The document does not establish any rights for any person and is not binding on CDSA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. In no event shall CDSA be liable for any claim, damages or other liability arising from the use of this document.
This document will be updated and revised at frequent intervals.
If you have any suggestions, please email to firstname.lastname@example.org
- Guidance Document for IEC
- Annexure 1: Checklist for Submission of Applications for Registration of Ethics Committee
- Annexure 2: Layout for Timelines of SAE Reporting
- Annexure 3: Excel Sheet for Compensation Calculation