我院开展临床试验用药品集中管理的实践体会

Experience of the Development of Centralized Management of Drugs for Clinical Trial in Our Hospital

目的:构建临床试验用药品集中管理模式,加强试验用药品的规范化管理。方法:分别从标准操作规程的内容及相关管理措施、工作体会等方面介绍我院建立的以机构专用药库为平台的临床试验用药品集中管理模式。结果与结论:我院建立了试验用药品的接收、保管、发放及回收的标准操作规程,并通过改进试验用药品信息化管理功能模块、药库配备温湿度监控系统、对试验用药品有效期实行色标管理等举措,实现了试验用药品机构内流转各环节的全程规范化管理及药物管理员、研究者、质控人员等的信息共享,保证了药物临床试验的质量。该模式具有药物管理员可随时掌控项目研究进展等优点,但不适用于所有的临床试验流程。

OBJECTIVE：To strengthen the standardized management by constructing the centralized management of drugs for clinical trial. METHODS：The centralized management of drugs for clinical trial in our hospital was introduced from standardized operational procedures,management measure,management experience,etc. RESULTS CONCLUSIONS：The standardized operational procedures for the reception,storage,distribution and retrieval of drugs for clinical trial are established in our hospital;and a series of measures were carried out to achieve standardized management at every stage of drug circulation,and information sharing among drug administrator,researcher,quality control staff,etc.,and guarantee the quality of clinical drug trial,as the improvement of informatization management function module,temperature and humidity monitoring system,and color code management of period of validity. The model possesses the advantages that drug administrator can supervise the progress of research project at any time,but is not suitable for all clinical trial procedure.