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

Alex C Cheng1, Rhonda Facile2, John Owen2

  • 1Vanderbilt University Medical Center, Nashville, TN, USA.

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Summary
This summary is machine-generated.

This study developed a method to convert Clinical Data Acquisition Standards Harmonization (CDASH) electronic case report form (eCRF) metadata into REDCap data dictionaries. This facilitates the adoption of CDASH standards in academic research, improving data quality and interoperability.

Keywords:
Clinical TrialData Collection StructureDesign FormElectronic Data ProcessingHealth Information Interoperability

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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.