Good clinical practice (GCP) is an international ethical and scientific quality standard for designing, recording, and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety, and well-being of trial subjects are protected and that the clinical trial data are credible.
The increasing globalization of clinical research, coupled with limited inspection resources, means that only a sample of sites and clinical studies can be inspected. The European Medicines Agency (EMEA) and the U.S. Food and Drug Administration (FDA) have collaborated on international GCP inspection activities. The objectives of the initiative include the sharing of information on inspection planning, policy and outcomes, and the conduct of collaborative inspections. This initiative is an important contribution to ensuring the protection of clinical trial subjects.
