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.
What You Need to Know? 👇
What are civil money penalties for ClinicalTrials.gov violations?
Civil money penalties are monetary fines FDA can assess against responsible parties or submitters who fail to submit required clinical trial information to ClinicalTrials.gov, submit false information, or fail to provide proper certifications to FDA.
How does FDA identify ClinicalTrials.gov compliance violations?
FDA primarily identifies violations through evidence collected during Bioresearch Monitoring Program (BIMO) inspections and evaluation of complaints received by the Agency. They review public and non-public information available to FDA.
What is the maximum penalty amount for ClinicalTrials.gov violations?
The statutory maximum is $10,000 for all violations in a single proceeding, plus an additional $10,000 per day for continuing violations after 30 days notification. Amounts are adjusted annually for inflation.
When does FDA prioritize enforcement for ClinicalTrials.gov violations?
FDA uses a risk-based approach, focusing on trials of higher-risk products, products addressing significant public health needs, entities with patterns of noncompliance, and trials with multiple regulatory violations.
What happens after receiving a Pre-Notice Letter from FDA?
Recipients have 30 calendar days to address potential violations. FDA then reviews compliance and may issue a Notice of Noncompliance, giving another 30 days to remedy issues before seeking civil penalties.
Can ClinicalTrials.gov penalty cases be settled with FDA?
Yes, respondents can engage in settlement discussions with FDA after filing an Answer to the Complaint. Parties may agree to settle before a presiding officer’s decision, considering mitigating factors.
What You Need to Do 👇
Recommended Actions
- Establish process to monitor compliance with ClinicalTrials.gov registration and results reporting requirements
- Implement quality control checks for accuracy of information submitted to ClinicalTrials.gov
- Maintain documentation of ClinicalTrials.gov submissions and FDA certifications
- Develop procedure to promptly address any Preliminary Notice of Noncompliance within 30-day window
- Create process to track and verify remediation of any identified non-compliance
- Train relevant personnel on ClinicalTrials.gov requirements and potential penalties for non-compliance
- Establish internal audit program to periodically review compliance with ClinicalTrials.gov requirements
- 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
Related references and norms 📂
- 21 CFR Part 17: Civil Money Penalty Hearings
- 42 CFR Part 11: Clinical Trials Registration and Results Information Submission