基于临床试验机构办公室质量控制认知的调研

A survey on cognition about quality control of clinical trial institutions

临床试验机构办公室作为管理部门,通过质量控制实现对临床试验的质量监管。为了了解目前临床试验机构办公室质量控制的意义、效果及改进空间,笔者通过网络问卷的方式对78位临床试验参与人员进行调查,调查内容包括对机构办公室质量控制的总体认知和评价,对机构办公室质量控制提出建议,以期探索出充分发挥机构办公室质量管理职责、提升机构办公室质量控制效能的有效方法,从机构管理角度促进临床试验质量提高。

As the management department,the clinical trial institution realizes the quality supervision of clinical trials through quality control. In order to understand the significance,effect and improvement space of quality control of clinical trial institutions,78 clinical trial participants in our hospital were investigated by means of online questionnaire,including the overall cognition and evaluation of the quality control of institutions and suggestions for the quality control of institutions in order to explore an effective way to give full play to the quality management responsibilities of institutions,improve the quality control efficiency of institutions,and promote the quality of clinical trials from the perspective of institutional management.