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医疗机构在取得药物临床试验资格前后,须接受各级监管部门不同类型的现场检查。检查类型大致分为五种:药物临床试验机构资格认定检查、资格认定复核检查、日常监督检查、有因检查和药品注册现场核查。医疗机构获取药物临床试验资格后,在开展药物临床试验研究方面接受的检查属于后四种。这四种类型检查内容有些相同,但由于出发点不同,检查的角度不一样,检查要点各不相同。本文简要介绍五种现场检查类型,进而阐述后四种现场检查的要点。
Before and after obtaining the drug clinical trial qualification, medical institutions must accept different types of on-site inspections by regulatory authorities at all levels. There are basically five types of examinations: qualification examination of drug clinical trial institutions, review of accreditation, routine supervision and inspection, on-site inspection for examination and drug registration. Medical institutions to obtain the drug clinical trial qualification, carried out in clinical trials of drugs to accept the inspection belongs to the latter four. The four types of checks are somewhat the same, but due to the different starting point, the inspection point of view is not the same, check points vary. This article briefly describes the five types of on-site inspections, and then elaborates on the last four points of on-site inspections.