General Principles & Definitions

Studies involving human subjects that are endorsed or supported by the WSACS should be conducted according to the principles of Good Clinical Practice (GCP). Although primarily intended for clinical studies that 1) investigate the clinical or pharmacological effect of an investigational product, 2) evaluate measurement devices or techniques, 3) report epidemiological data, or 4) describe the effect of an intervention other than administration of a pharmacological product, all studies should adhere to this internationally adopted standard. Multicentre studies are, per se, organized by a number of individuals, and each of them has different tasks and responsibilities. For clarity, the tasks of the different actors in the organization of a trial and related terms are explained here, based on the responsibilities as described in the ICH-GCP document. These should be used appropriately throughout the protocol and in all communications related to the study.