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.
The key objectives of the EMEA-FDA GCP initiative, which began in September 2009 with an 18-month pilot phase, are:
- To conduct periodic information exchanges on GCP-related information in order to streamline sharing of GCP inspection planning information, and to communicate effectively and in a timely manner on inspection outcomes.
- To conduct collaborative GCP inspections by sharing information, experience and inspection procedures, cooperating in the conduct of inspections and sharing best-practice knowledge.
- To share information on interpretation of GCP, by keeping each regulatory agency informed of GCP-related legislation, regulatory guidance and related documents, and to identify and act together to benefit the clinical research process.
Find out more about the EMEA-FDA GCP initiative. To read additional articles about the globalization of clinical trials, subscribe to our monthly publication, Global Communicator.
Tags: clinical trial, GCP, global, informed consent, research, Translation