Making Clinical Data Acquisition Standards Harmonization (CDASH) Electronic Case Report Forms Available on the REDCap Shared Data Instrument Library.

ABSTRACT

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. Implementation 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.