Regulatory Focus™ > News Articles > India Requires Audio-Visual Record of Clinical Trial Subject Consent

India Requires Audio-Visual Record of Clinical Trial Subject Consent

Posted 21 November 2013 | By Alexander Gaffney, RAC 

In compliance with an earlier Supreme Court ruling, India's Office of Drugs Controller issued an Order on 19 November 2013 requiring audio-visual recordings of informed consent by subjects that are to participate in global clinical trials approved between 1 January and 31 August 2013. 

The recorded informed consent must be obtained prior to the commencement of the five global trials approved in that time, and the trials my not be undertaken until the necessary administrative framework is established that will ensure compliance with the Order.  Moreover, the requirement for audio-visual recording of consent has been extended to all clinical trials, not only global trials.


CDSCO Order

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