Audio video recording of informed consent [Regulatives / Guidelines]

posted by sathish.munaga – India, 2015-10-14 14:19 (3407 d 10:08 ago) – Posting: # 15557
Views: 4,235

Hi,

Yes, the GSR (611 E) is clear to have AV consent for vulnerable subjects and audio consent is for anti HIV and anti leprosy drugs.

However, the AV consent may provide additional assurance in the process to have better understanding and acceptance of trail volunteers and compliance to AUDIO-VISUAL RECORDING OF INFORMED CONSENT PROCESS IN CLINICAL TRIAL" published in Jan 2014 and this process is encouraged by global regulatory agencies.

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