Good Clinical Practice (GCP) is an international set of standards that ensures the integrity of clinical research. It is a collaborative effort with concepts and guidelines from the International Conference on Harmonization (ICH), World Health Organization (WHO) and regulatory agencies throughout the world.
The US Food and Drug Administration (FDA) defines GCP as:
“A standard for the design, conduct, performance, monitoring, auditing, recording, analyses and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.”
The US FDA has collaborated and adopted International GCP guidance for the conduct of clinical trials, which have been in effect since the 1970s, addressing both GCP (Good Clinical Practices) and HSP (Human Subject Protection). GCP is applied when conducting trials with human subjects, and should be followed when generating clinical trial data that are intended to be submitted to regulatory authorities.
