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A system for documenting FDA violations of research reporting requirements, triggered when the FDA issues a Notice of Noncompliance to study researchers. The notice indicates failure to meet legal requirements under the Food and Drug Administration Amendments Act of 2007 (FDAAA 801), and includes three categories:
  • Violations: Marked when the FDA issues and posts a Notice of Noncompliance for: ◦ Failing to submit required study information ◦ Submitting false or misleading information ◦ Omitting primary and secondary outcomes
  • Corrections: Documented when researchers fix the violation and the FDA confirms and posts the correction, though there may be a delay between the update and the correction being noted
  • Penalties: Recorded when the FDA imposes and posts consequences for the violation
The National Library of Medicine must add this information to study records when provided by the FDA.

Eligibility criteria

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