About the Ethics Committee

The Ethics Committee (EC) plays a vital role in ensuring the protection, safety, rights, and well-being of human subjects participating in clinical trials and biomedical research regulated under NDCTR 2019.

The Ethics Committee is responsible for the ethical review, approval, and oversight of clinical trial proposals, informed consent process and documents, subject recruitment procedures, and compensation in case of trial-related injury or death, as applicable.

The Ethics Committee is constituted as per Chapter III of NDCTR 2019 requirements and includes members from medical, scientific, ethical, legal, and lay backgrounds to ensure independent, competent, and unbiased review of research proposals.

All Ethics Committees registered under Chapter III of NDCTR 2019, CDSCO are required to operate transparently and independently, maintain proper documentation, and submit reports as mandated by regulatory authorities.

The Ethics Committee remains committed to upholding the highest ethical standards in clinical research and ensuring public trust in the regulatory oversight of clinical trials in India.

• Functionalities Ethics Committee  

• Approval Process Ethics Committee  

•     Guidelines Document
  
  1. CDSCO GCP Guidelines  
•     Sugam User Manual
•     FAQ
•     Checklist Documents
  1. Undertaking Format 
  2. Check-List_Regsitration
  3. Check-List_Re-Regsitration