Announcements Letter to MMC by FMES, PUCL-MH, FAOW, and MFC urging to restore its order suspending licenses of two doctors accused of abetting the suicide of Dr Payal Tadvi

The contours of clinical research in India

Sachin Nikarge

DOI: 10.20529/IJME.2010.062


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.

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