摘要: |
临床研究数据核查是保证数据质量的关键内容,数据核查直接关系到数据分析和研究结果。随着电子数据远程获取系统(EDC)的广泛应用,如何开展网络数据的核查还缺乏相应的技术规范。介绍在中医药临床数据管理过程中进行网络在线数据核查的方法、内容及处理措施。 |
关键词: 数据核查 数据管理 临床研究 电子化数据获取 质量控制 |
DOI:10.11656/j.issn.1672-1519.2014.11.09 |
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Online data verification in clinical trials of traditional Chinese medicine |
LIU Zhi, SHANG Hong-cai, ZHAI Jing-bo, CAO Hong-bo, LEI Xiang
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Institute of Traditional Chinese Medicine, Tianjin Univeristy of Traditional Chinese Medicine, Tianjin 300193, China
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Abstract: |
Clinical research of data verification is the key to ensure the qualityof the content data, data verification is directly related to the data analysis and research results. Along with the electronic remote dataacquisition system (Electronic Data Capture, EDC) has been widely used, how to develop a network data verification is also a lack ofappropriate technical specifications. This paper introduces themethod, network online data verification in traditional Chinese medicine clinical datamanagement in the process of content and treatment measures. |
Key words: data verification data management clinical research electronic data acquisition quality control |