Findings and recommendations from a root cause analysis of a clinical trial randomization error

Abstract Introduction: Participants in NIH-funded multicenter clinical trial received the compound opposite to the randomization intention. We report the problem, subsequent root cause analysis (RCA) and corrective and preventative action (CAPA). Methods: The RCA was independently facilitated to...

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Hlavní autoři:	Muayad Hamidi, Omar Abbaas, Pavan Bhatraju, Subrata Debnath, Jonathan Gelfond, Joel E. Michalek, Karen Nijland, Jeannette Watterson, Melanie Zuniga Rapp, Jason Bates, Susanne Schmidt, Kumar Sharma, Laura Aubree Shay, Hung-da Wan, Meredith Zozus
Médium:	Artigo
Jazyk:	Inglês
Vydáno:	Cambridge University Press 2026-01-01
Edice:	Journal of Clinical and Translational Science
Témata:	Clinical trial methods procedures guideline adherence quality
On-line přístup:	https://www.cambridge.org/core/product/identifier/S2059866126107493/type/journal_article
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