Data management procedures in the Asthma Clinical Research Network
Data management procedures in the Asthma Clinical Research Network
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DOI：
10.1016/s0197-2456(01)00170-2
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发表时间：
2001-12-01
期刊：
影响因子：
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通讯作者：
Kunselman, SJ
中科院分区：
文献类型：
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作者：
Pogash, RM;Boehmer, SJ;Kunselman, SJ
设计良好的数据管理流程对于确保多中心临床试验中收集的数据质量至关重要。本文描述了哮喘临床研究网络数据协调中心开发的数据管理流程和系统。设计了手动和电子流程的组合，以处理从收集到统计分析的临床试验数据。开发了一个分布式数据库管理系统，该系统由用于单独数据处理活动的模块化应用程序组成，用于输入、跟踪、验证、确认和编辑收集的数据。此外，还讨论了监测和报告数据质量的程序。(C)Elsevier Science Inc. 2001.
Well-designed data management processes are essential in ensuring the quality of data collected in multicenter clinical trials. This paper describes the data management processes and systems that were developed by the data coordinating center of the Asthma Clinical Research Network. A combination cf manual and electronic processes has been designed to process clinical trial data from the point of collection to statistical analysis. A distributed database management system consisting of modular applications for separate data processing activities was developed to enter, track, verify, validate, and edit collected data. In addition, processes for monitoring and reporting data quality are discussed. (C) Elsevier Science Inc. 2001.