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RegisterAudio video recording of informed consent [Regulatives / Guidelines]
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.
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.
Complete thread:
- Audio video recording of informed consent Ohlbe 2015-08-20 18:03 [Regulatives / Guidelines]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Audio video recording of informed consent suchit_bhavsar 2015-08-21 07:30
- Audio video recording of informed consentsathish.munaga 2015-10-14 12:19
- Audio video recording of informed consent suchit_bhavsar 2015-08-21 07:30
Ing. Helmut Schütz