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目前,国内外缺乏对临床试验数据管理进行全面考核的指标,我国CDMC推出了临床试验数据管理质量考核体系。本文对数据管理的绩效考核内容、考核指标的建立和应用以及对数据管理发展的影响等方面进行了介绍。综述了国内外的一些关于考核指标的研究进展,通过具体的实例来强调考核指标的重要性,并对数据管理的考核指标提出建议,旨在解决开发考核指标时遇到的问题,使企业通过考核指标达到流程改善和优化的目的。
At present, there is no domestic and international indicators of a comprehensive assessment of clinical trial data management, and CDMC in China has launched a clinical trial data management quality assessment system. This article introduces the content of performance appraisal, the establishment and application of appraisal index and the influence on the development of data management. This paper summarizes some research progress at home and abroad about the evaluation index, emphasizes the importance of the evaluation index through the concrete example, and puts forward the suggestion on the evaluation index of the data management in order to solve the problems encountered in the development of the evaluation index, Assessment indicators to achieve process improvement and optimization purposes.