| 摘要: |
| 临床数据管理是临床试验的关键性工作,对研究结果的准确可靠性起着决定性作用,本文论述了临床数据的质量标准,介绍了临床数据管理规范化发展中的重要法规和原则,回顾了国内外临床数据管理系统的发展及其现状,并提出了积极借鉴国际先进管理模式和引入国外规范化临床数据管理软件系统,以提高国内临床数据管理水平的建议. |
| 关键词: 临床试验、数据管理系统、临床数据 |
| DOI：10.3724/SP.J.1008.2006.00721 |
| 投稿时间：2006-06-27修订日期：2006-07-03 |
| 基金项目: |
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| Development of clinical data management system: current status home and abroad |
| SUN Ya-lin,HE Jia,CAO Yang |
| (第二军医大学卫生勤务学系卫生统计学教研室,上海,200433) |
| Abstract: |
| Clinical data management, a critical part of clinical trials, plays a decisive role in assuring the accuracy and reliability of the trail results. This article discusses the quality standards of clinical data, introduces the important rules and principles for standardized clinical data management, and reviews the development and current status of clinical data management home and abroad. It is proposed that we should learn the advanced clinical data management modes from international partners and introduce standardized clinical management software from abroad, so as to improve the clinical data management in China. |
| Key words: clinical trials database management systems clinical data |
