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Civil Money Penalties Related to ClinicalTrials.gov Requirements

This guidance describes FDA's current thinking regarding civil money penalties for violations related to ClinicalTrials.gov requirements, including failure to submit required clinical trial registration/results information, submitting false/misleading information, and certification violations. It applies to responsible parties and submitters of certain applications to FDA regarding drug, biological, and device products.

  1. Establish process to monitor compliance with ClinicalTrials.gov registration and results reporting requirements
  2. Implement quality control checks for accuracy of information submitted to ClinicalTrials.gov
  3. Maintain documentation of ClinicalTrials.gov submissions and FDA certifications
  4. Develop procedure to promptly address any Preliminary Notice of Noncompliance within 30-day window
  5. Create process to track and verify remediation of any identified non-compliance
  6. Train relevant personnel on ClinicalTrials.gov requirements and potential penalties for non-compliance
  7. Establish internal audit program to periodically review compliance with ClinicalTrials.gov requirements
  8. Maintain records demonstrating good faith efforts to comply with requirements

Key Considerations

Other considerations

  • FDA will identify violations through inspections under Bioresearch Monitoring Program and evaluation of complaints
  • FDA will use risk-based approach focusing on:
    • Higher risk products or significant public health needs
    • Pattern of previous non-compliance
    • Non-compliance with other regulatory requirements
  • Preliminary Notice of Noncompliance will be sent giving 30 days to address violations
  • Civil money penalties up to $10,000 for all violations in single proceeding
  • Additional penalties up to $10,000/day if violation not corrected within 30 days
  • Factors considered for penalty amount include nature/gravity of violation, ability to pay, history of violations, culpability
  • 21 CFR Part 17: Civil Money Penalty Hearings
  • 42 CFR Part 11: Clinical Trials Registration and Results Information Submission

Original guidance

  • Civil Money Penalties Related to ClinicalTrials.gov Requirements
  • HTML / PDF
  • Issue date: 2020-08-14
  • Last changed date: 2024-11-05
  • Status: FINAL
  • Official FDA topics: Medical Devices, Good Clinical Practice (GCP), Investigation & Enforcement, Drugs, Biologics
  • ReguVirta summary file ID: 1ffcd516f3a35b7295d8af3623fa4151
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