临床试验数据管理中的常见问题探讨

Key issues on the clinical trial data management

本文就临床试验管理工作中的团队构建、培训、标准操作规程、文件记录管理、执行力以及沟通等方面应如何管理进行阐述,并对现今行业内普遍存在的管理薄弱、欠缺或不完善等问题进行探讨,提出对策,以期提高数据管理的质量和效率,为临床试验的顺利实施提供保障。

This paper is prepared to discuss the common issues in data management, sucouand training of data management team, standard operation procedure, document management, execution andcommunication, strategies to correct and prevent mistakes, and measures to improve the quality and efficiencyof clinical trials and data management.