国际多中心临床试验的监查

Monitoring in multicenter clinical trial

为贯彻临床试验管理规范 ,保证多中心临床试验的质量。本文以ADVANCE多中心临床试验为例 ,简介监查的程序和方法。提出监查员应当具有医药知识和临床试验经验 ,应当按程序到研究点去核查CRF ,研究文件和有关资料。

In order to ensure the multicenter clinical trial quality by carrying out good clinical practice, the monitoring procedures and methods were introduced for the multicenter trial of ADVANCE. We suggest that the monitor should adequate medical and pharmaceutical qualifications and have the clinical trial experience. The monitor should visit each site to review the CRF, study files and data according to the procedures. Good monitoring is assistance to improve the quality of multicenter clinical trial.