WHO guidelines for good clinical practice (GCP) for trials on pharmaceutical products: responsibilities of
the investigator.
期刊名称: Annals of Medicine
作者: Idnpn-heikkil,Juhana E
年份: 1994年
期号: 第2期
关键词: WHO GOOD CLINICAL PRACTICE; GCP AND WHO
摘要: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 rearch on human subjects. A number of countries have no regulations for clinical trials or the regulations require supplementation. In
tho 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 discuss the functions, obligations and responsibilities of the investigator as defined in the WHO GCP.
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