| 摘要: |
| 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。 |
| 关键词: 研究者 依从性 电子化 数据管理 |
| DOI：10.11656/j.issn.1673-9043.2014.06.03 |
| 分类号: |
| 基金项目:国家青年科学基金项目(81202849);教育部新世纪优秀人才计划(NCET-09-0900);天津市高等学校创新团队资助(TD12-5032)。 |
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| Compliance problems and countermeasures of the use of electronic data management system in the clinical research of traditional Chinese medicine |
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LIU Zhi, SHANG Hong-cai, ZHAI Jing-bo, CAO Hong-bo
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Institute of Traditional Chinese Medicine, Tianjin Univeristy of Traditional Chinese Medicine, Tianjin 300193, China
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| Abstract: |
| 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. |
| Key words: researcher compliance electronic data management |
