从药物临床试验数据核查看申办者的职责履行情况

Perspectives on the implementation of sponsors' responsibilities from the drug clinical trial data inspection

申办者作为药物临床试验的发起组织者、经费提供者和试验监查者,在药物临床试验中发挥着至关重要的作用。本文根据《药物临床试验质量管理规范》(GCP)的相关规定及药物临床试验监督检查新形势下对申办者的职责要求,结合药物临床试验数据核查中申办者存在的常见问题,对申办者在临床试验中应履行的职责进行分析和探讨。

Sponsors,who serve as the organizers,financial providers and monitors of drug clinical trials,play a critical role in drug clinical trials.In accordance with the good clinical practice(GCP)and the requirements for sponsors under the new situation of drug clinical trial supervision,this paper analyzed and discussed the responsibilities of sponsors in drug clinical trials in association with the common problems related to sponsors during the clinical trial data inspection.