药物临床试验中申办者与其他主体的法律关系研究

The legal relationship between sponsors and other bodies of drug clinical trials

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。

Sponsor,the R＆D institutions and drug manufacturers,which is the initiator,organizer and supervisor of clinical trials,is one of the most vital parts in clinical trials. As the principal body responsible for the overall process of clinical trials,sponsors play an important role in safeguarding the safety of subjects,as well as ensuring the authenticity and effectiveness of trial data. Using documentary research method,this article illuminated the obligation which should be fulfilled by the sponsors in the clinical trials. On this basis,the legal relationship between sponsors and other bodies was clarified,as well as the legal liability when destroying the legal relationship.