从药物临床试验数据核查看研究者的职责履行情况

Perspectives on the performing of investigators’ responsibilities from drug clinical trial data inspection

在药物临床试验中,研究者作为实施者、临床试验质量及受试者安全权益的直接责任人,发挥着关键作用。本文根据《药物临床试验质量管理规范》(good clinical practice,GCP)的相关规定及药物临床试验监督检查新形势下对研究者的职责要求,结合药物临床试验数据核查中研究者存在的常见问题,对研究者在临床试验中应履行的职责进行分析和探讨。

Investigators,who serve as the implementers of drug clinical trials,the persons directly responsible for the quality of drug clinical trials as well as the safety and rights of subjects,play a critical role in drug clinical trials.In accordance with the good clinical practice(GCP)and the requirements for investigators under the new situation of drug clinical trial supervision,this paper analyzed and discussed the responsibilities of investigators in drug clinical trials,combined with the common findings related to investigators during the clinical trial data inspection.