There are around 1200 registered independent and institutional ethics committees. All registered ethics committees have to go through accreditation process which was introduced recently by NABH and responsibility is assigned to quality council of India (QCI) to accredit all registered ethics committees in India. The ethics committee should review and accord its approval to a clinical trial as per Schedule Y, the Good Clinical Practice Guidelines for Clinical Trials in India and other applicable regulatory requirements for safeguarding rights, safety and well-being of the trial subjects.
The applications of registration of Ethics Committee have to be mandatorily filed online by www.cdscoonline.gov.in.
http://www.cdsco.nic.in/writereaddata/NOTICE-%20COSECR.pdf
Accreditation of Ethics Committees involved in supervision of clinical trials is mandatory with effect from 01.01.2018 and before that accreditation will be voluntary. Ministry has approved accreditation of Ethics Committee for Clinical trials. NABH has now started accepting application for Accreditation of Ethics Committee program with refer to letter no. QCI/NABH/CDSCO/15.
http://www.nabh.co/Announcement/Accreditation_ECApproval.pdf
Draft Standards And Application Format For Accreditation Of Ethics Committee, Investigator And Clinical Trial Site
http://www.cdsco.nic.in/Forms/list.aspxlid=2074&Id=23
Keeping in view the registration and accreditation requirement of Ethics Committee, this course has been framed to provide a basic understanding about the functioning and responsibility of Ethics Committee. Further this course will also be helpful to all stakeholders involved in clinical trial to comply with the necessary requirements and application process of accreditation with NABH & Registration with CDSCO.
This brief e-course covers the accreditation process of NABH along with registration process of IEC with CDSCO.
This Course has following modules:
- Regulation and Guidelines for Ethics Committee in India
- Composition of Ethics Committee
- Standard Operating Procedures of Ethics Committee
- Functioning of Ethics Committee
- Submission of Clinical Trial Dossier to Ethics Committee
- Records Maintained by Ethics Committee
- Review and Approval Process of Ethics Committee
- Responsibility of Investigator Towards Ethics Committee
- Registration of Ethics Committee with CDSCO
- Accreditation of Ethics Committee by NABH
