Certifying Compliance with Clinical Trial Registration Requirements on Form FDA 3674
This guidance clarifies FDA's requirements regarding Form FDA 3674 certifications that must accompany certain drug, biological product, and device applications/submissions. The certification confirms compliance with clinical trial registration and results reporting requirements under Title VIII of FDAAA.
Recommended Actions
- Implement process to submit Form FDA 3674 with:
- INDs and new clinical protocols
- NDAs and efficacy supplements
- BLAs and efficacy supplements
- ANDAs
- PMAs and panel track supplements
- HDEs
- 510(k)s referencing clinical trials
- Ensure Form FDA 3674 includes:
- Appropriate NCT numbers when available
- Accurate certification of compliance
- Establish tracking system for:
- Clinical trial registration status
- Results reporting compliance
- NCT number documentation
- Train regulatory staff on:
- When certification is required
- How to complete Form FDA 3674
- Enforcement discretion categories
- Implement quality check to verify certification requirements before submission
Key Considerations
Clinical testing
- Certification required for applications/submissions containing clinical trial information
- Applicable to clinical trials that must be registered on ClinicalTrials.gov
- New clinical protocols submitted to an IND require certification
Other considerations
- Form FDA 3674 must include NCT numbers when available
- Failure to submit certification or submitting false certification is prohibited
- FDA will exercise enforcement discretion for:
- Civil Money Penalties Related to ClinicalTrials.gov Requirements
- Electronic Copy (eCopy) Program for Medical Device Submissions: Technical Standards and Requirements
- Electronic Submission Requirements for Medical Device Submissions
Related references and norms
- 21 CFR 50.25(c): Requirements for informed consent documents
- 42 CFR part 11: Clinical trials registration and results information submission
- 21 CFR 312.3: IND definitions
- 21 CFR 312.30(a): Protocol amendments
Original guidance
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