509 Regulatory Lens of a QA/QC Project Manager

OBJECTIVES/GOALS: The primary purpose of the QA/QC Project Manager (PM), appointed under the NCATS UL1 administrative supplement award, is to facilitate quality and timely NCATS prior approval submissions preventing study start delays. Other goals include supporting these projects’ IRB applications...

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Bibliographic Details
Main Authors: Rachel Bennett, Christine Sego Caldwell
Format: Article
Language:English
Published: Cambridge University Press 2024-04-01
Series:Journal of Clinical and Translational Science
Online Access:https://www.cambridge.org/core/product/identifier/S2059866124004333/type/journal_article