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

Area of Science:

• Clinical Research Informatics
• Data Management
• Translational Science

Background:

• REDCap is a widely used data management platform for clinical and translational research.
• CDISC standards, such as CDASH, enhance clinical trial data quality and efficiency but have limited adoption in academic institutions.

Purpose of the Study:

• To develop a scalable methodology for converting CDISC CDASH eCRF instrument metadata into REDCap data dictionaries.
• To simplify the adoption and use of CDASH instruments by research teams within the REDCap Consortium.

Main Methods:

• Developed replicable methods to translate metadata from CDASH Foundational and Crohn's Disease eCRFs into REDCap eCRF metadata.
• Made translated instruments available in the REDCap Shared Data Instrument Library for broad accessibility.

Main Results:

• Successfully translated metadata from 34 CDASH Foundational and 20 CDASH Crohn's Disease eCRFs into REDCap format.
• Provided standardized eCRFs for direct import into REDCap projects, enabling immediate use in clinical trial data collection.

Conclusions:

• Disseminating CDISC standards via the REDCap community increases accessibility for academic medical centers.
• Wider adoption of CDISC standards by academic researchers can improve data interoperability with industry-sponsored trials and facilitate secondary data use for discoveries.