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 ORIGINAL ARTICLE
Year : 2014  |  Volume : 51  |  Issue : 2  |  Page : 113-116

Standard operating procedure for audio visual recording of informed consent: An initiative to facilitate regulatory compliance


1 SAARC Federation of Oncology, Mumbai, India
2 Indian Cooperative Oncology Network, Mumbai, India
3 Department of Medical Oncology, Kidwai Memorial Institute of Oncology, Bengaluru, Karnataka, India
4 Tata Cancer Hospital, Visakhapatnam, Andhra Pradesh, India
5 Department of Finance, Sydenham Institute of Management Studies, Research and Entrepreneurship Education, Mumbai, India
6 Academy of Clinical Excellence, Mumbai, India
7 Founder Trustee, Highway Infinite, Pune, Maharashtra, India
8 Department of Political Science, Chetana College, Mumbai, India
9 Department of Research, RGCI, New Delhi, India
10 Department of Medical Oncology, Fortis Hospital, Kolkata, West Bengal, India
11 Tata Memorial Center, Mumbai, India

Correspondence Address:
P M Parikh
SAARC Federation of Oncology, Mumbai
India
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/0019-509X.138158

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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 ethical standards and that the recording is stored as well as archived in an appropriate manner. The SOP was developed keeping in mind all relevant orders, regulations, laws and guidelines and have been made available online. Since, we are faced with unique legal and regulatory requirements that are unprecedented globally, this SOP will allow the AV recording of the informed consent to be performed, archived and retrieved to demonstrate ethical, legal and regulatory compliance. We also compared this to the draft guidelines for AV recording dated 9 th January 2014 developed by Central Drugs Standard Control Organization. Our future efforts will include regular testing, feedback and update of the SOP.






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