浅谈伦理委员会质量监查

On Quality Monitoring by Ethics Committee

从伦理委员会质量监查员的确定,临床试验研究的监查程序以及监查结果三个方面阐述了伦理监查的全过程,提出监查员应当具有医药知识和临床经验,应当按程序到研究点去核查临床试验,研究文件和有关资料。伦理委员会质量监查有助于全面监查严重不良事件,改善医患关系,促进临床实验顺利地进行。

This article describes the whole process of the ethics monitoring from the following three aspects ： the determination of the ethics committee quality monitor; monitoring procedure of the clinical trials research; and its monitoring results. It also puts forward that the monitor should have medicine knowledge and experience on clinical trials, should follow the procedures to check out the clinical trials, documents and relevant materials at the research spot. Standardized monitoring will help to comprehensive monitoring the serious adverse events, to improve the doc tor patient relationship, to make sure the clinical trials go on wheels and end well.