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Ohlbe ★★★ France, 2015-08-20 20:03 (3163 d 13:02 ago) Posting: # 15317 Views: 6,316 |
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Dear all, and particularly contributors from India, A Gazette notification informing of amendments to Schedule Y of the Drug and Cosmetic Rules has recently been published. Do I understand it correctly that an audio and video recording of the informed consent process is no longer required for BE trials ? At least for BE trials for generics (may still be required for a BE trial on a new chemical entity) ? — Regards Ohlbe |
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suchit_bhavsar ★ India, 2015-08-21 09:30 (3162 d 23:36 ago) (edited by Ohlbe on 2015-08-21 09:57) @ Ohlbe Posting: # 15318 Views: 4,932 |
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Hello to all of you, I think this is for the vulnurable subjects only. As per draft guideline by CDSCO "AUDIO-VISUAL RECORDING OF INFORMED CONSENT PROCESS IN CLINICAL TRIAL" published in Jan 2014 states that "ensures that audio- visual recording of the informed consent process of the Participants is done and the documentation preserved, adhering to the principles of confidentiality" Regards, Suchit Bhavsar Edit: Full quote removed. Please delete everything from the text of the original poster which is not necessary in understanding your answer; see also this post! [Ohlbe] |
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sathish.munaga ☆ India, 2015-10-14 14:19 (3108 d 18:47 ago) @ suchit_bhavsar Posting: # 15557 Views: 3,905 |
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Hi, Yes, the GSR (611 E) is clear to have AV consent for vulnerable subjects and audio consent is for anti HIV and anti leprosy drugs. However, the AV consent may provide additional assurance in the process to have better understanding and acceptance of trail volunteers and compliance to AUDIO-VISUAL RECORDING OF INFORMED CONSENT PROCESS IN CLINICAL TRIAL" published in Jan 2014 and this process is encouraged by global regulatory agencies. |
Ing. Helmut Schütz