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. 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.

The REDCap consortium: Building an international community of software platform partners.

The Research Electronic Data Capture (REDCap) data management platform was developed in 2004 to address an institutional need at Vanderbilt University, then shared with a limited number of adopting sites beginning in 2006. Given bi-directional benefit in early sharing experiments, we created a broader consortium sharing and support model for any academic, non-profit, or government partner wishing to adopt the software. Our sharing framework and consortium-based support model have evolved over time along with the size of the consortium (currently more than 3200 REDCap partners across 128 countries). While the "REDCap Consortium" model represents only one example of how to build and disseminate a software platform, lessons learned from our approach may assist other research institutions seeking to build and disseminate innovative technologies.

Procurement of shared data instruments for Research Electronic Data Capture (REDCap).

REDCap (Research Electronic Data Capture) is a web-based software solution and tool set that allows biomedical researchers to create secure online forms for data capture, management and analysis with minimal effort and training. The Shared Data Instrument Library (SDIL) is a relatively new component of REDCap that allows sharing of commonly used data collection instruments for immediate study use by research teams. Objectives of the SDIL project include: (1) facilitating reuse of data dictionaries and reducing duplication of effort; (2) promoting the use of validated data collection instruments, data standards and best practices; and (3) promoting research collaboration and data sharing. Instruments submitted to the library are reviewed by a library oversight committee, with rotating membership from multiple institutions, which ensures quality, relevance and legality of shared instruments. The design allows researchers to download the instruments in a consumable electronic format in the REDCap environment. At the time of this writing, the SDIL contains over 128 data collection instruments. Over 2500 instances of instruments have been downloaded by researchers at multiple institutions. In this paper we describe the library platform, provide detail about experience gained during the first 25months of sharing public domain instruments and provide evidence of impact for the SDIL across the REDCap consortium research community. We postulate that the shared library of instruments reduces the burden of adhering to sound data collection principles while promoting best practices.