从机构办公室角度谈药物临床试验的质量控制

Analysis on quality control of drug clinical trials from perspective of institution office

质量控制是药物临床试验过程中一个重要的环节,质量控制的执行力度决定了药物临床试验的质量。机构办公室作为质量控制的主要力量,应严把质量关。质量控制是一项系统工程,应贯穿在药物临床试验项目实施的整个过程中,从项目的立项、项目启动、项目实施过程到项目结题和资料归档都需要严密的质量控制。本文从以上四方面对项目的质量控制进行了详细的阐述。

Quality eontrol is an important aspect in process quality control determines the quality of drug clinical trials. Institution should father to close quality. Quality control is a systematic project, of drug clinical trial. The enforcement of office as the main force of quality control which should be canrried out throughout clinical drug trials. Project approving, project initiating, implementation of the project and project completion require strict quality control. This article analyzed quality control of drug clinical trials from the above four aspects in detail.