Can I read ICMR Guidelines for Clinical Trials on EtoBox?

ICMR Guidelines for Clinical Trials by Nidhi Chhajed is a document available to read on EtoBox.

What is ICMR Guidelines for Clinical Trials about?

The document discusses clinical trial monitoring and auditing in India. It outlines the roles and guidelines of regulatory bodies like the Drug Controller General of India, Local Ethics Committees, and ICMR in approving and monitoring clinical trials. It describes the minimum requirements for on-site monitoring of trials, including annual visits, pre-study site visits, and reviewing documentation. It also defines the purpose of audits in systematically examining clinical practices and resources to investiga

Author

Nidhi Chhajed

Language

EN