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| 药品上市后临床试验远程数据管理模式的架构 |
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曹红波1,2, 刘智2, 李楠1, 翟静波1, 王辉1, 刘春香1, 商洪才1,2
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1.天津中医药大学中医药研究院, 天津 300193;2.天津中医药临床评价研究所, 天津 300193
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| 摘要: |
| 药品上市后临床试验是生产药品临床证据的重要手段,而临床试验的质量控制是证据可靠性的关键.数据管理是药品上市后临床试验质量控制的重要内容,随着计算机技术的发展和应用,临床试验的远程数据管理模式逐渐成为趋势,文章对药品上市后临床试验当中传统数据管理与远程管理的区别和远程管理模式的架构作一介绍. |
| 关键词: 临床试验 远程数据管理 药品 |
| DOI：10.11656/j.issn.1672-1519.2014.12.08 |
| 分类号: |
| 基金项目:国家自然科学基金青年科学基金项目(81202 849);天津市高等学校创新团队资助(TD12-5032);天津市高等学校科技发展基金计划(20110202). |
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| Remote mode of data management for a certain medicine in clinical trial after appearing on the market |
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CAO Hong-bo1,2, LIU Zhi2, LI Nan1, ZHAI Jing-bo1, WANG Hui1, LIU Chun-xiang1, SHANG Hong-cai1,2
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1.Institute of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medcine, Tianjin 300193, China;2.Tianjin Institute of TCM Clinical Evaluation, Tianjin 300193, China
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| Abstract: |
| Clinical trial is an important measure in providing some clinical evidences for production of a certain medicine. While the quality control of the clinical trial is the key for the evidence reliability. Data management is an important content in quality control of clinical trial after its appearing on the market and the remote data management mode of clinical trial has gradually become a trend along with the development and application of computer technology. In this paper, we will discuss the difference between the classical data management and remote data management. Meanwhile and the framework of remote data management will be introduced. |
| Key words: clinical trial remote data management medicine |
