Regarding Distribution of ICFs to volunteers [Study Per­for­mance]

posted by drgunasakaran1  – 2012-06-05 12:13 (5126 d 12:19 ago) – Posting: # 8661
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Dear Mr Suchit Bhavsar,

We must provide the copies of the Signed ICF to the subjects as per the DCGI's Rule and the subject should sign in the "Issuance of ICF copy Form" after receiving the copy of the ICF.

Quote from 3rd Amendment, Drugs and Cosmetics, 2011, Page no 11 of 13.
Copies of the Patient Information Sheet and duly filled Informed Consent Form shall be handed over to the subject or his/her attendant also.

Reference
—
Dr Gunasakaran Sambandan MD
Disclaimer: The replies/posts are my personal opinions, and they do not represent my company's views on the same. LinkedIn

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