The Clinical Trial Toolkit has been designed by CDSA by involving a team of experts in order to provide guidance to researchers who are interested in conducting clinical trials in India.
ICMR Bioethics Unit was actively involved with CDSA in the development of the toolkit.
It has been developed in accordance with the Indian Drugs and Cosmetics Act,
the New Drugs and Clinical Trials Rules, 2019,
the Good Clinical Practice Guidelines and the ICMR National Ethical Guidelines for Biomedical and Health Research Involving Human Participants, 2017.
It not only provides guidance on both academic and regulatory clinical trials but also serves as an interactive roadmap on the various steps a researcher will need to keep in mind while planning a clinical trial in India.