Checks expected by regulatory authorities

Abstract

Conceptually, good clinical practice (GCP) can be defined as the set of behaviours undertaken, in the course of conducting and/or monitoring a clinical investigation, which are required to ensure the internal and external validity of the experiment. In this sense GCP, like adequate trial design and reliable analytical methodology, must be considered a sine qua non of any clinical study intended to serve as a source of evidence to support the safety and efficacy of a drug destined for marketing in the USA.