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The contours of clinical research in India
Nikarge, Sachin
Nikarge, Sachin
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Nikarge, Sachin
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research ethics
professional ethics
professional ethics
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Bioethics
Medical ethics
Health ethics
Medical ethics
Health ethics
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n183co178.pdf
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Abstract
"The Clinical Trials Registry-India (CTR-I), set up by the Indian Council of Medical Research’s National Institute of Medical Statistics, is a freely available and searchable primary register. Anybody wishing to conduct a clinical trial in India must declare 20 items of registration data set as required by the World Health Organization’s International Clinical Trial Registry Platform, in addition to items required by the Indian registry such as ethics committee approval status and regulatory clearance by the Drug Controller General of India (DCGI), etc, before the enrolment of the first patient. While this register is meant primarily for trials conducted in India, the CTR-I also accepts registration of trials conducted in other countries in the region. The CTR-I was formally launched on July 20, 2007 (1) with the aim of paving the way for improved transparency, accountability, and reporting of results of all clinical trials in India and in the south or southeast Asian region (2). A total of 324 clinical trials were registered in this registry, over a period of about two years. On June 15, 2009, the DCGI made registration mandatory for every new trial (3, 4). Incidentally, this mandate coincided with the publication of the first factsheet in the October-December 2009 issue of this journal
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2010-07
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With permission of the license/copyright holder