Research Misconduct in FDA-Regulated Clinical Trials: A Cross-sectional Analysis of Warning Letters and Disqualification Proceedings.
PMID : 29714564 ·
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Résumé
The US Food and Drug Administration (FDA) ensures that clinical trials meet regulatory and ethical standards through inspections of researchers, also known as clinical investigators. Inspections with significant regulatory/ethical violations may result in regulatory actions, such as a warning letter or a Notice of Initiation of Disqualification Proceedings and Opportunity to Explain (NIDPOE). Objectives included the standardization of regulatory violation themes cited by the FDA for novel analys
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