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研究电子数据采集 (REDCap) 的联盟驱动的快速软件验证

Theresa A Baker^1,2, Teresa Bosler¹, Adam L C De Fouw³

¹Vanderbilt Institute for Clinical and Translational Research, University Medical Center, Nashville, TN, USA.

Journal of clinical and translational science

|January 20, 2025

概括

快速验证过程 (RVP) 提高了临床研究中REDCap (电子数据捕获) 的监管合规性. 这种结构化的方法提高了测试效率,并确保REDCap符合不断变化的监管标准.

科学领域:

临床研究信息学临床研究信息学
临床试验中的数据管理
研究中的法规合规性

背景情况:

学术和非营利研究越来越多地面临监管提交要求.
研究人员越来越依赖电子数据捕获 (EDC) 系统,如REDCap.
需要高效且符合EDC的验证流程.

研究的目的:

引入和评估REDCap的快速验证过程 (RVP).
提高EDC系统的监管合规性和运营效率.
为REDCap软件建立一个结构化验证方法.

主要方法:

REDCap功能的分类.
开发有针对性的验证测试.
应用结构化和标准化测试语法.

主要成果:

在测试效率和流程优化方面观察到显著改善.
成功验证连续发布的REDCap软件版本.
证明了REDCap的弹性和适应能力的增强.

结论:

在保持灵活性的同时,RVP成功地确保REDCap符合监管标准.
社区驱动的模式促进合作和知识共享.
RVP将REDCap定位为当前和未来临床研究挑战的可靠和合规工具.

关键词:

电子数据捕获电子数据捕获临床研究是临床研究.监管合规性监管合规性软件验证软件的验证

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