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Audio visual recording of informed consent process
http://www.pharmabiz.com/NewsDetails.aspx?aid=83688&sid=21#:~:text=Audio%20visual%20recording%20of%20informed%20consent%20can%20provide,used%20as%20evidence%20in%20the%20court%20of%20law.
DRAFT GUIDELINES ON AUDIO-VISUAL RECORDING …
https://www.kem.edu/wp-content/uploads/2019/06/Draft-Guidelines-on-AV-recording-of-ICD-process-in-clinical-trial-06-01201409.01.2014.pdf
obtaining written informed consent, audio-visual recording of the informed consent process of each trial subject, including the procedure of providing information to the subject and his/her understanding on such consent is required to be done while adhering to the principles of confidentiality. Such audio-visual recording and related documentation would be preserved.
DRAFT GUIDELINES ON AUDIO-VISUAL RECORDING OF …
https://www.dsmedicalcollege.org/iechs/downloads/14_Document_8_ICF_7_Audio-Visual%20Recording%20Consent%20Guidelines.pdf
1. Audio-Visual (AV) recording of the entire informed consent process is mandatory for all clinical trials approved by the DCGI and consent for the same should be taken. 2. AV recording for any re-consenting procedure that may follow must be done. 3. If the participant is unable to give consent for medical or legal reasons, the consent should be taken
Audio-visual presentation of information for informed ...
https://pubmed.ncbi.nlm.nih.gov/24809816/
Audio-visual presentation of informed consent may improve participant satisfaction with the consent information provided. However its effect on satisfaction with other aspects of the process is not clear. There is insufficient evidence to draw conclusions about anxiety arising from audio-visual informed consent.
Standard operating procedure for audio visual recording …
https://pubmed.ncbi.nlm.nih.gov/25104190/
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 …
Title:Audio Visual (AV) Recording of Informed …
http://www.nirrh.res.in/wp-content/uploads/2018/08/10-Audio-Video-Consent.pdf
Audio Visual (AV) recording of the informed consent process: As per the DCGI office order dated 31st July 2015, Audio Visual (AV) recording of the informed consent process was made mandatory for regulatory clinical trials. This office order is in support to order dated 21st Oct 2013 from the Honorable Supreme Court of India.
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