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Updated: Jun 13, 2026

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Operation of the Collaborative Composite Manufacturing (CCM) System
Published on: October 1, 2019
协作合规:一个基于联盟的框架,在CTSA机构中实现21 CFR第11部分在REDCap中的准备
Theresa Baker1, Teresa Bosler1, April Green2
1Vanderbilt University Medical Center, USA.
Journal of clinical and translational science
|February 26, 2026
概括
学术机构现在可以使用新的实施指南在REDCap中实现美国FDA 21 CFR Part 11合规. 这种协作资源减少了供应商的依赖,并改善了电子记录和签名的监管遵守.
科学领域:
- 监管科学 监管科学
- 医疗信息学 医疗信息学
- 翻译科学 翻译科学
背景情况:
- 学术机构面临的挑战是满足美国FDA 21 CFR Part 11对REDCap电子记录和签名的要求.
- 缺乏明确的指导方针阻碍了合规,增加了对外部供应商的依赖.
研究的目的:
- 为REDCap用户开发和传播实施指南,以实现21 CFR第11部分的合规性.
- 促进机构之间的合作,以改善监管遵守.
主要方法:
- 来自国家推进翻译科学中心 (NCATS) 的一个工作组开发了这本指南.
- 该指南发布给学术研究机构.
主要成果:
- 在六个月内,来自164个机构的259个人访问了该指南.
- 用户报告说,减少了对供应商的依赖,改进了文档,并成功实施了第11部分准备好的REDCap系统.
结论:
- 技术和监管专家之间的协作努力可以有效地改善监管合规性.
- 该NCATS开发的指南促进了REDCap用户的第11部分合规性,增强了研究企业.
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