ABSTRACT
The Good Clinical Practices (GCPs) regulations section (21 CFR 312) in the Code of Federal Regulations outlines the responsibilities of the clinical investigator, the drug sponsor, and the clinical trial monitor involved in investigational new product development. In addition to this regulated conduct of clinical investigations, each participant has a moral and ethical responsibility for the safety of subjects who participate in these trials. Good clinical practices have long been the norm for the investigator, as written in the 1572 Form, but the first proposed regulations pertaining to investigator, sponsor, and monitor were circulated in 1977 and 1978. In 1987, 10 years later, GCPs were published as final regulations in the Code of Federal Regulations. Today, investigators, sponsors, and monitors are obligated by law to follow these GCPs.
