Government makes new rule for clinical trial after consultation with the Drugs Technical Advisory Board that an audio - video recording of vulnerable subjects in clinical trials of New Chemical Entity or New Molecular Entity including procedure of providing information to the subject and his understanding on such consent, shall be maintained by the investigator for record.
As per the notification, GSR 611(E), released by CDSCO - an audio - video recording of the informed consent process in case of vulnerable subjects in clinical trials of New Chemical Entity or New Molecular Entity including procedure of providing information to the subject and his understanding on such consent, shall be maintained by the investigator for record.
But in case of clinical trial of anti-HIV and anti-Leprosy drugs, only audio recording of the informed consent process of individual subject including the, procedure of providing information to the subject and his understanding on such consent shall be maintained by the investigator for record.
Prior Ministry of Health and Family Welfare published notification in the Gazette of India number GSR 364(E), dated the 7th June, 2013, and invited objections and suggestions from all persons likely to be affected thereby before the forty five days of notification publication.
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