Audio-Visual Recording of Informed Consent
There has been much talk over the past 6+ months about the new requirements for the patient consent process to be videoed. These requirements were implemented in late 2013 through the DCGI Administration Order of 19 Nov 2013. The CDSCO has also recently (Jan 2014) published a “Draft Guideline on Audio-Visial Recording of Informed Consent“.Video
Although, the regulations and DGCI Administrative Order specifically state applicability to ‘clinical trials’, it is assumed, until otherwise notified, that these requirements also apply to non-interventional studies.
Further information can be found at: