title: [Introduction of new GCP (good clinical practice)].
abstract: In 1997, a new GCP has taken effect by the Ministry of Health and Welfare, Japan, and will be enforced as of April, 1998. The GCP regulates the method of clinical trials in the light of ethics and science. The New GCP requires written informed consent, enforcement of the responsibility of the client and so on.
authors.affiliation: Pharmaceutical and Medical Bureau Ministry of Health & Welfare, Tokyo, Japan.
authors.forename: S
authors.initials: S
authors.lastname: Miyake
mesh_terms: D000970:Antineoplastic Agents; D002986:Clinical Trials as Topic / Q000331:legislation & jurisprudence*; D006801:Humans; D007258:Informed Consent; D007564:Japan; D007880:Legislation, Drug; D009369:Neoplasms / Q000188:drug therapy
chemical_list: D000970:Antineoplastic Agents