The Clinical Trials Toolkit has been designed by CDSA to provide guidance to researchers who are interested in conducting clinical trials in India. The purpose of the toolkit is to serve as an interactive roadmap and provide guidance and information on the various steps a researcher will need to keep in mind while planning a clinical trial in India.

The toolkit provides guidance on both academic and regulatory clinical trials. However, many of the steps are applicable to all types of research studies.

The toolkit has been adapted from the NIHR Clinical Trials Toolkit, and conceived considering the best practices in research in India and globally. It is in accordance with the Indian Drugs and Cosmetics Act, the New Drugs and Clinical Trials Rules, 2019 and the Good Clinical Practice Guidelines. Links to all relevant sites that provide information on existing guidelines and regulations have been provided wherever applicable. In the preparation of this toolkit, we have sought feedback from experts in different areas to try and ensure that the routemap is as comprehensive as possible and that the it is clear and easy to understand.

Recent Changes to the Toolkit

On 19th March 2019, the Ministry of Health and Family Welfare (MoHFW) released the New Drugs and Clinical Trial Rules, 2019, which are effective from the date of publication (the only exception is Chapter IV – Ethics Committee for Biomedical and Health Research – this will come into force 180 after the publication date). The Clinical Trials Toolkit for India has been updated to reflect the New Drugs and Clinical Trial Rules, 2019.


We would welcome your feedback and suggestions on how we can improve the toolkit.

Please help to keep the toolkit up-to-date by reporting any out-of-date content or broken links.

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