在REDCap共享数据仪器库上提供临床数据采集标准协调 (CDASH) 电子案例报告表格.
Alex C Cheng1, Rhonda Facile2, John Owen2
1Vanderbilt University Medical Center, Nashville, TN, USA.
概括
这项研究开发了一种方法,将临床数据采集标准协调 (CDASH) 电子病例报告表 (eCRF) 的元数据转换为REDCap数据字典. 这有助于在学术研究中采用CDASH标准,提高数据质量和互操作性.
科学领域:
- 临床研究信息学
- 数据管理数据管理
- 翻译科学 翻译科学
背景情况:
- REDCap是一个广泛用于临床和翻译研究的数据管理平台.
- CDISC标准,如CDASH,提高临床试验数据的质量和效率,但在学术机构的采用是有限的.
研究的目的:
- 开发一种可扩展的方法来将CDISC CDASH eCRF仪器元数据转换为REDCap数据字典.
- 简化REDCap联盟内的研究团队采用和使用CDASH工具.
主要方法:
- 开发了可复制的方法,将CDASH基础和克罗恩病eCRF中的元数据转换为REDCap eCRF元数据.
- 在REDCap共享数据仪器库中提供翻译的仪器,以实现广泛的可访问性.
主要成果:
- 成功将34个CDASH基础和20个CDASH克罗恩病eCRF的元数据翻译成REDCap格式.
- 提供了标准化的eCRF,可以直接导入REDCap项目,以便在临床试验数据收集中立即使用.
结论:
- 通过REDCap社区传播CDISC标准增加了学术医疗中心的可访问性.
- 学术研究人员更广泛地采用CDISC标准,可以改善与行业赞助的试验的数据互操作性,并促进对发现的二次数据使用.
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