Idänpään-Heikkilä J E
Division of Drug Management of Policies, World Health Organization, Geneva, Switzerland.
Ann Med. 1994 Apr;26(2):89-94. doi: 10.3109/07853899409147334.
WHO has developed Guidelines for Good Clinical Practice (GCP) for Trials on Pharmaceutical Products in order to establish globally applicable standards for the conduct of biomedical research on human subjects. A number of countries have no regulations for clinical trials or the regulations require supplementation. In those countries, the relevant health authority may designate, in part or in whole, the WHO GCP Guidelines as the basis on which clinical trials will be conducted. This article discusses the functions, obligations and responsibilities of the investigator as defined in the WHO GCP.
世界卫生组织制定了《药品临床试验规范指南》，以便为针对人类受试者开展的生物医学研究确立全球适用的标准。一些国家没有临床试验法规，或者法规需要补充。在这些国家，相关卫生当局可能部分或全部指定世界卫生组织的《临床试验规范指南》作为开展临床试验的依据。本文讨论了世界卫生组织《临床试验规范指南》中所定义的研究者的职能、义务和责任。
