中医药临床研究者使用电子化数据管理系统的依从性问题及对策

Compliance problems and countermeasures of the use of electronic data management system in the clinical research of traditional Chinese medicine

在信息化飞速发展的今天,实施电子化临床试验数据管理是中医药临床试验数据管理的发展趋势,然而在项目实施过程中发现研究者对电子化数据管理的依从性不佳,并发现较差的依从性会对控制临床试验数据的质量产生直接的影响。在中医药大规模临床试验中采用电子化数据管理模式后,部分研究中心及研究者根据临床试验研究中依从性的现状,分析原因、提出对策。

In the rapid development of information technology, the implementation of electronic clinical trial data management is the trend of development of traditional Chinese medicine clinical trial data management,however, in the process of implementing the project the author found that the researchers on the compliance of the electronic data management is poor, and found that compliance is poor will have a direct impact on the quality control of clinical trial data. This paper describes the use of electronic data management in large-scale clinical trials of traditional Chinese medicine, part of the research centers and research in clinical trials of compliancestatus, and analyze the causes, and puts forward some countermeasures.