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Collaborative compliance: A consortium-based framework for achieving 21 CFR part 11 readiness in REDCap across CTSA institutions

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 compli...

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Principais autores: Theresa Baker, Teresa Bosler, April Green, Jason Lones, Katie Keenoy, Bridget Adams, Bas de Veer, Brian Bush, Stephanie Oppenheimer, Sheree Hemphill, Elinora Price, Haley Neese, Ashley Tippett, Audrey Perdew, Randy Madsen, Catherine Bauer-Martinez, Robert Bradford, Paul Harris, Alex Cheng
Formato: Artigo
Idioma:Inglês
Publicado em: Cambridge University Press 2026-01-01
Colecção:Journal of Clinical and Translational Science
Assuntos:
Compliance
electronic data capture
software
working groups
implementation
Acesso em linha:https://www.cambridge.org/core/product/identifier/S2059866126102362/type/journal_article
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