Indian journal of cancer
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Indian journal of cancer · Apr 2014
Standard operating procedure for audio visual recording of informed consent: an initiative to facilitate regulatory compliance.
The office of the Drugs Controller General (India) vide order dated 19 th November 2013 has made audio visual (AV) recording of the informed consent mandatory for the conduct of all clinical trials in India. We therefore developed a standard operating procedure (SOP) to ensure that this is performed in compliance with the regulatory requirements, internationally accepted ethical standards and that the recording is stored as well as archived in an appropriate manner. ⋯ We also compared this to the draft guidelines for AV recording dated 9 th January 2014 developed by Central Drugs Standard Control Organization. Our future efforts will include regular testing, feedback and update of the SOP.