WHO guidelines for good clinical practice (GCP) for trials on pharmaceutical products: responsibilities of the investigator.
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.
Division of Drug Management of Policies, World Health Organization, Geneva, Switzerland.
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Idänpään-Heikkilä
D002985:Clinical Protocols / Q000592:standards; D002986:Clinical Trials as Topic / Q000592:standards*; D030881:Disclosure; D004341:Drug Evaluation / Q000592:standards*; D004345:Drug Industry; D015507:Drugs, Investigational; D028744:Ethics Committees, Research; D004992:Ethics, Medical; D006801:Humans; D007258:Informed Consent; D038622:Internationality; D018579:Patient Selection; D012108:Research Personnel; D035842:Research Subjects; D012109:Research Support as Topic; D014944:World Health Organization
D015507:Drugs, Investigational