三级医院药物临床试验机构建设管理实践

Construction and management practice of drug clinical trial institution in a grade Ⅲ hospital

目的:介绍我院药物临床试验机构建设管理的实践经验,为同行提供借鉴参考。方法:从组织管理构架、制度和标准操作规程(standard operation procedure,SOP)、软硬件设施、资质培训、试验用药管理、档案管理、质量控制、监查、稽查和视察等方面介绍我院临床试验机构的经验。结果与结论:我院的药物临床试验机构通过了国家食品药品监督管理总局(CFDA)的2次资格认证检查,建设取得了一定成就,但是仍需改进,如为药房配备温湿度在线监控系统、引进专用的临床试验信息系统、补充机构现有人员不足等。在国家新政策的鼓励下,临床试验工作会蓬勃发展。

Objective： Introducing the construction and management practice experience of drug clinical trial institution of our hospital in order to provide a reference for other hospitals. Methods： The experience of drug clinical trial institution of our hospital was summed up,from the aspects of organizational structure,regulations and standard operation procedure（ SOP）,hardware and software supports,qualification training,management of experimental drugs,archives administration,quality control,monitoring,audit as well as inspection. Results and Conclusion： Drug clinical trial institution of our hospital has passed two qualification examinations by China Food and Drug Administration（ CFDA）,and the construction of drug clinical trial institution of our hospital has obtained certain achievement. But it still needs improvement,such as the equipping of online temperature and humidity monitoring system to the experimental pharmacy,the introduction of specific information system for clinical trial,the settle of staff shortage and so on. Under encouragement of the new national policy,the work of clinical trial will flourish in the near future.