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Protocol Deviations: A Holistic Approach from Defining to Reporting

Laura Galuchie1, Catherine Stewart2, Frank Meloni3

  • 1Global Clinical Trial Operations, Merck Research Laboratories, 126 East Lincoln Ave, Rahway, NJ, 07065, USA. laura.galuchie@merck.com.

Therapeutic Innovation & Regulatory Science
|March 30, 2021
PubMed

Keywords:
Issue managementProtocol deviation (PD)Quality Management System (QMS)Risk assessment categorization tool (RACT)Risk managementTransCelerate

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