药物临床试验档案管理的特点及实践

Characteristic and practical discussion on file management of drug clinical trials

试验资料管理是临床试验的重要部分,试验档案具有资料多、跨时长、保密性强等特点。本文分析了临床试验各阶段常见的资料管理问题,依据实践经验针对问题探讨相应措施,建议从加强硬件设施建设、构建层级化资料管理以及提高档案管理人员业务水平三个方面做好药物临床试验资料管理工作。

File management is an important part of a clinical trial. The characteristics of clinical trial files included more information, long time span, and strong confidentiality. This paper analyzed common problems in various stages of clinical trial file management and discussed the corresponding measures to solve the problems on the basis of experience. In order to do well in the file management, this paper maked suggestions from strengthening the hardware infrastructure, constructing the hierarchical data management, and improving the management level of archives management staff.