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申办者(药品研发机构、药品生产企业)作为临床试验的发起者、组织者和监查者,是药物临床试验中最重要的主体之一,是对临床试验全过程负责的第一责任人,其职责履行将对保障临床试验受试者安全、试验数据真实有效起到重要作用。本文以申办者为研究对象,采用文献研究法,明确其在临床试验过程中的应当履行的职责,并在此基础上明确了申办者与其他行为主体之间的法律关系以及法律责任。
As the sponsor, organizer and supervisor of clinical trials, sponsors (drug R & D institutions, pharmaceutical manufacturers) are the most important subjects in drug clinical trials and are the first responsible persons for the whole process of clinical trials. The fulfillment of their duties will play an important role in guaranteeing the safety of clinical trial subjects and the true and effective experimental data. This paper takes the sponsor as the research object and adopts the method of literature research to clarify the responsibilities that should be fulfilled in the course of clinical trial. On this basis, the legal relationship and the legal responsibilities between the sponsor and other actors are clarified.