基于药物临床试验质量控制的文档管理规范化探讨

The standardization of document management based on drug clinical trial quality control

药物临床试验文件是记录临床试验过程中所产生的所有信息、资料,反映研究者、申办者和监察员对GCP和所有的现行管理要求的依从性,并且作为药品监督管理部门进行监察、新药审批的第一手资料和关键依据。收集首都医科大学附属北京儿童医院完成的和在研的药物临床试验项目质量控制中文档管理中发现的问题,采用回顾性分析方法,对存在的问题进行归类,结合我机构对药物临床试验质量控制经验归纳出档案管理的要求,完善药物临床试验质量控制的全过程管理。

The clinical trial document contains all information and data in the clinical trial process,reflecting the compliance of the researchers, the sponsor and CRA to the GCP and all existing regulatory requirements, as the first hand information and key basis for the supervision and approval of the drug administration department. This paper collected from document management problems found by the retrospective analysis method, combined with my agency for quality control of drug clinical trials experience summing up the requirements of archives management, improve the whole process of drug clinical trials quality control management.