Good clinical practice (GCP)

Abstract

syn. good clinical regulatory practice, good clinical research practice, good clinical trial practice; EC (III): “A standard by which clinical trials are designed, implemented and reported so that there is public assurance that the data are credible, and that the rights, integrity and confidentiality of subjects are protected”; FDA does not give an official definition of GCP; within the EC the guidelines for GCP came into force 1 July 1991 and are mandatory for the member states since 1 January 1992; → see also good clinical trial practice.