title: [New Japanese GCP--from the standpoint of a sponsor].
abstract: The new Japanese GCP enacted on the basis of ICH-GCP adopts more clear concepts of quality assurance for a clinical trial. This article briefly describes its principles. Sponsors are now responsible not only for initiation but also for management of clinical trials. Thus, discussions have been under taken the points to be considered in, among others, imple mentation/maintenance of the Quality Assurance/ Control systems, preparation/amendment of a clinical trial protocol, entrusting to a coordinating investigator/committee, monitoring, audit, and direct access to source documents and all other trial-related records. Further, this addresses the required reorganization which the sponsor should strive for as well as the sponsor's requests to participating medical institutions such as adoption of a "study coordinator". To improve the quality of a clinical trial, it would be necessary to refer not only to GCP but also to other current guidelines such as those harmonized at the ICH.
authors.affiliation: Takeda Chemical Ind., Ltd., Tokyo, Japan.
authors.forename: O
authors.initials: O
authors.lastname: Ebi
mesh_terms: D002986:Clinical Trials as Topic / Q000592:standards*; D016903:Drug Monitoring; D006801:Humans; D007258:Informed Consent; D008485:Medical Audit; D009369:Neoplasms / Q000628:therapy*; D010819:Physician's Role; D017410:Practice Guidelines as Topic; D011785:Quality Assurance, Health Care