Research Deviations in FDA-Regulated Clinical Trials: A Cross-Sectional Analysis of FDA Inspection Citations
The US Food and Drug Administration (FDA) ensures clinical trials meet regulatory/ethical standards through inspections. If FDA Investigators observe potential violations of regulatory requirements during an inspection, a firm will receive a Form FDA 483, Inspectional Observations. Violations cited have resulted in the death of human research subjects, prosecution of research personnel, and denial of approval for new medical products. Objectives included the standardization of Violation Themes cited for analysis by inspection firm type, geographic location, and Violation Theme citation to provide insight into regulatory violations
Article, 2018