Clinical Research Regulatory Affairs

In the words of Sir Austin Bradford Hill, “Clinical Research is an ethically and scientifically designed experiment with the aim of answering some precisely framed questions”. With humans involved, Clinical trials of new drugs are always associated with some ethical issues. To take care of those issues, clinical research regulatory affairs play a crucial role.

Before conducting clinical trials of newly discovered drugs, or even repeated phase-I studies, or phase II to IV studies, clinical research regulatory affairs approval is required. This approval is given by clinical research regulatory authorities upon fulfillment of certain conditions and meeting of standards.

Clinical trials are conducted in accordance to a planned protocol / set of instructions. These protocols are designed in order to comply with the ICH GCP, and other guidelines, so that the clinical research regulatory standards are met before and during the conduct of clinical trials, the non-compliance of which may lead to termination of the clinical trial approval.

In India, clinical research regulatory affairs are governed by Drugs and Cosmetics Act. The new drugs cannot be administered to human subjects without the permission from Drug Controller General of India (DCGI). In order to obtain permission, from DCGI, Clinical Trial Application (CTA) has to be submitted. CTA includes protocol for the study, Informed Consent Documents, a list of investigators participating in the study, and background information about the drug according to the schedule Y of the Drug and Cosmetics Rules also called as investigators brochure.