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Collaborative compliance: A consortium-based framework for achieving 21 CFR part 11 readiness in REDCap across CTSA
Theresa Baker1, Teresa Bosler1, April Green2
1Vanderbilt University Medical Center, USA.
None:
Academic research institutions using REDCap often face challenges aligning with U.S. FDA requirements for electronic records and signatures under 21 CFR Part 11 (Part 11). A National Center for Advancing Translational Sciences(NCATS) working group developed an implementation guide for Part 11 compliance in REDCap. Within six months after release, 259 individuals representing 164 institutions accessed the guide. Individuals who downloaded the guide reported reduced vendor reliance, improved documentation, and establishment Part 11-ready REDCap instances. This working group demonstrated how collaboration between technical and regulatory experts at many peer institutions is effective in improving regulatory compliance across the research enterprise.
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