Financial Disclosure Requirements for Clinical Investigators
This guidance clarifies FDA's requirements for financial disclosure by clinical investigators involved in FDA-regulated clinical studies used to support marketing applications. It covers the collection, reporting and evaluation of financial interests and arrangements between clinical investigators and sponsors that could affect the reliability of data submitted to FDA.
Recommended Actions
- Establish process to identify all sponsors providing material support for covered studies
- Develop questionnaires/forms to collect complete financial disclosure information from investigators before study start
- Implement system to track and update financial disclosure information during study and 1-year follow-up period
- Document steps taken to minimize potential bias from disclosed financial interests
- Maintain complete records of all financial disclosure information and correspondence
- Include required certifications/disclosures in marketing applications
- Consider financial interests when designing studies to minimize potential bias
- Consult with FDA early if there are concerns about specific financial arrangements
- Exercise due diligence in obtaining information from investigators and document efforts
- Review financial disclosure requirements with clinical investigators during site initiation
Key Considerations
Clinical testing
- Clinical investigators must disclose financial interests/arrangements to sponsors before participating in studies
- Information must be updated during study and for 1 year after completion
- Applies to both US and foreign clinical sites
- Large multi-center efficacy studies are covered, but large open safety studies generally not covered
Safety
- Studies addressing specific safety concerns are covered if single investigator makes significant contribution
- Large open safety studies with multiple investigators generally not covered
Other considerations
- Disclosable financial interests include:
- Compensation affected by study outcome
- Proprietary interests in tested product
- Equity interests exceeding $50,000 in publicly traded sponsor
- Any equity in non-public sponsor
- Significant payments over $25,000
- Sponsors must collect financial information before study start
- Applicants must submit certifications/disclosures with marketing applications
- FDA may refuse to file applications without required financial information
- Records must be maintained for 2 years after approval
Related references and norms
- 21 CFR Part 54: Financial Disclosure by Clinical Investigators
- 21 CFR Part 312: Investigational New Drug Application
- 21 CFR Part 812: Investigational Device Exemptions
Original guidance
- Financial Disclosure Requirements for Clinical Investigators
- HTML / PDF
- Issue date: 2013-02-01
- Last changed date: 2023-08-10
- Status: FINAL
- Official FDA topics: Medical Devices, Good Clinical Practice (GCP), Drugs, Biologics, Investigational Device Exemption (IDE)
- ReguVirta summary file ID: f4532c868bf388bac38c2b0d56ccdc09
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