Table 1.

A list of documents needs to be submitted in CT-01 format for the ethics committee registration application

A formal application letter for EC registration

Application for registration in accordance with the requirements as specified in the ICMR National Ethical Guidelines 2017

Authority under which the EC has been constituted

Memberships requirements

The terms of reference of the EC

Conditions of appointment in EC and the quorum requirement

SOP for resignation/replacement and/or removal

Recent self-attested biodata and relevant training certificates

The updated full SOP to be followed by the EC

SOP followed by EC for vulnerable population

Training policy SOP

SOP to monitor and/or prevent the conflict of interest

Details regarding audit or inspection of EC

Undertaking showing EC members’ details (autogenerated by the portal)

CT-01 (autogenerated by the portal)

EC=Ethics committee, SOP=Standard operating procedures, ICMR=Indian Council of Medical Research, BHR=Biomedical and health research, COI=Conflict of interest, TOR=Terms of reference