在REDCap共享数据仪器库上提供临床数据采集标准协调(CDASH)电子病例报告表格

A. Cheng, Rhonda Facile, John Owen, Richard Marshall, K. Mellars, Nan Kennedy, Brenda L. Minor, Kyle Mcguffin, Paul A. Harris
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引用次数: 0

摘要

REDCap数据管理平台的开发和部署背后的指导原则一直包括关注工作流程设计,使临床和转化研究人员能够轻松实现最佳实践。CDASH等CDISC标准帮助临床研究界提高了临床试验数据的效率、可操作性和质量,但在学术机构中的应用有限。目的:创建一种可扩展的方法,将CDISC CDASH eCRF仪器元数据转换为REDCap数据字典,以简化REDCap联盟研究团队对CDASH仪器的采用和使用。结果:我们使用可复制的方法将34个CDASH基础eCRF和20个CDASH克罗恩病eCRF的元数据转换为REDCap eCRF元数据,并使这些工具可在REDCap共享数据仪器库中使用,以便在REDCap联盟中广泛共享和吸收。用户可以将标准化的ecrf直接导入他们的REDCap项目中,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标准将增加学术医疗中心对这些标准的可及性。让学术临床研究人员使用CDISC标准可能会导致更多的研究数据集与制药公司赞助的试验互操作,并从临床研究数据的二次使用中获得更多发现。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Making Clinical Data Acquisition Standards Harmonization (CDASH) Electronic Case Report Forms Available on the REDCap Shared Data Instrument Library
Introduction: A guiding principle behind the development and deployment of the REDCap data management platform has always included attention to workflow design that allows easy implementation of best practices for clinical and translational researchers. CDISC standards such as CDASH have helped the clinical research community improve the efficiency, actionability, and quality of their clinical trials data, but have had limited uptake among the academic institutions. Objective: To create a scalable methodology to convert CDISC CDASH eCRF instrument metadata into REDCap data dictionaries for the purpose of simplifying adoption and use of CDASH instruments by research teams across the REDCap Consortium.Results: We have used our replicable methods to translate metadata from 34 CDASH Foundational eCRFs and 20 CDASH Crohn’s Disease eCRFs into REDCap eCRF metadata and have made these instruments available in the REDCap Shared Data Instrument Library for widespread sharing and uptake across the REDCap Consortium. Users can import the standardized eCRFs directly into their REDCap projects for immediate use in clinical trial data collection.Conclusion: Disseminating CDISC standards through the REDCap community will increase the accessibility of these standards for academic medical centers. Having academic clinical researchers using CDISC standards may lead to more research datasets that interoperate with pharmaceutical sponsored trials, and more discoveries from secondary use of clinical research data.
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