Bioequivalence and Bioavailability Forum

Dear all,

Some Interesting and Salient points from the guidance

The process of signing/putting thumb impression by the subject/LAR/IW should also be video recorded.

In order to identify the subject/LAR/IW his/her photo ID may be documented. The video camera for the audio-visual recording should be of adequate capability to simultaneously capture the facial details of subject, LAR/Impartial Witness (if any), Investigator/authorised person present during the consent process. The audio-visual recording should be conducted in a room conducive to recording of disturbance-free audio and video of the consent process. During the videography process, care should also be taken not to include unrelated persons/patients at the hospital within the field of vision.

The video recording should be done using video camera of appropriate resolution and in a room free from any disturbance to ensure that the image is recognizable and the audio is clearly audible.

In order to maintain the confidentiality, the videographer should be engaged as part of the study team. Prior to initiation of the study, the Investigator should define and allocate the activities of audio-video recording of informed consent process to the respective identified person as videographer. The Investigator shall maintain the details of the person to whom he has delegated the duties of audio video recording.

Source: CDSCO's Draft guidelines on audio-visual recording of Informed consent process in clinical trials