Documents
to be submitted to Independent Ethics Committee approval Protocol.
Please send 11 copies of protocol, Case Record Form, Informed
Consent Documents in English & local vernacular, CV of
the investigators & information of the site to verify
the suitability for conduct of the trial, DCGI Approval letter/package
insert (whichever is applicable), Investigator Brochure.
The Independent Ethics Committee reviewing and approval fees for 1 project is Rs.25,000/-(inclusive of 1 centre) and for every additional centre it is Rs.5,000/-. Extension fees for 1 year is Rs. 5,000/-. This amount is payable in cheque/DD Drawn in favour of Independent Ethics Committee, Mumbai
