[关键词]
[摘要]
药物临床试验资料是记录临床试验全过程所产生的信息,是临床试验的重要部分,客观反映研究者、申办者及监察员对药物临床试验质量管理的依从性,是药品监督管理部门进行监察、新药审批的关键资料。着重分析临床试验各个阶段资料管理的难点,根据实践经验针对问题探讨相应对策。建议从完善档案制度及档案管理标准操作规程、提高资料管理员水平、利用信息化手段3个方面来提高资料管理水平。
[Key word]
[Abstract]
The clinical trial document contains information generated during the whole process of clinical trials, which objectively reflects the compliance of researchers, the sponsors and the supervisors on the quality management of drug clinical trials, as the key information and basis for drug supervision and management departments to monitor and approve new drugs. This paper focuses on analyzing the difficulties of data management in various stages of clinical trials, and probes into corresponding countermeasures according to practical experience. We suggest to improve the data management level from three aspects:perfecting the file system and file management standard operating procedures, improving the level of data administrators, and using information technology.
[中图分类号]
[基金项目]