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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主要な著者:	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
フォーマット:	Artigo
言語:	Inglês
出版事項:	Cambridge University Press 2026-01-01
シリーズ:	Journal of Clinical and Translational Science
主題:	Compliance electronic data capture software working groups implementation
オンライン･アクセス:	https://www.cambridge.org/core/product/identifier/S2059866126102362/type/journal_article
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