Annals of Medicine · 1994 · 81 citations · 1 references
PharmacyPharmaceutical PolicyPharmacologyClinical Trial RegulationGood Clinical PracticePharmaceutical RegulationClinical Trial AuthorizationClinical Trial DesignClinical Trial EthicsClinical Trial RegistrationClinical TrialsInvestigator ResponsibilitiesBiomedical Research EthicsClinical Protocol DesignClinical Trial OversightHuman Subjects OversightPharmaceutical DutiesPublic Health AuthorityResearch With Human SubjectsSubjects
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.
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