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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.

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By ReguVirta
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What You Need to Know? 👇

What are the key financial disclosure requirements for clinical investigators in medical device studies?

Clinical investigators must disclose compensation affected by study outcomes, proprietary interests in tested products, equity interests in sponsors (over $50,000 for public companies), and significant payments exceeding $25,000. These requirements apply to investigators, their spouses, and dependent children throughout the study and one year post-completion.

How do financial disclosure requirements differ between domestic and foreign clinical studies?

There is no difference. FDA requires the same financial disclosure obligations for both foreign and domestic covered clinical studies. Applicants must provide certification or disclosure information for all investigators regardless of study location, or certify they exercised due diligence but couldn’t obtain the information.

What constitutes a “covered clinical study” requiring financial disclosure?

A covered clinical study is any human study submitted in a marketing application that establishes product effectiveness (including equivalence studies) or where a single investigator significantly contributes to safety demonstration. This excludes Phase 1 studies, most pharmacokinetic studies, and large open safety studies.

When can FDA refuse to file a marketing application due to financial disclosure issues?

FDA may refuse to file applications lacking required financial information: either certification of no disclosable interests, complete disclosure statements with bias minimization steps, or certification of due diligence efforts with explanations for missing information. Complete financial disclosure documentation is mandatory for application acceptance.

What actions can FDA take when clinical investigators have concerning financial interests?

FDA can initiate data audits, request additional analyses excluding questionable investigator data, require independent confirmatory studies, or refuse to consider the study as basis for approval. The agency evaluates each case considering study design, investigator contribution, and bias minimization measures implemented.

How should sponsors minimize potential bias from investigator financial interests?

Sponsors should implement proper study design including randomization and blinding, use independent endpoint evaluators (especially in unblinded studies), employ multiple investigators and sites, and have non-conflicted personnel assess outcomes. These measures should be documented and submitted with disclosure statements to demonstrate bias mitigation efforts.

What You Need to Do 👇

  1. Establish process to identify all sponsors providing material support for covered studies
  2. Develop questionnaires/forms to collect complete financial disclosure information from investigators before study start
  3. Implement system to track and update financial disclosure information during study and 1-year follow-up period
  4. Document steps taken to minimize potential bias from disclosed financial interests
  5. Maintain complete records of all financial disclosure information and correspondence
  6. Include required certifications/disclosures in marketing applications
  7. Consider financial interests when designing studies to minimize potential bias
  8. Consult with FDA early if there are concerns about specific financial arrangements
  9. Exercise due diligence in obtaining information from investigators and document efforts
  10. 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 ID: f4532c868bf388bac38c2b0d56ccdc09
FDA guidance, Final
Medical Devices Good Clinical Practice (GCP) Drugs Biologics Investigational Device Exemption (IDE)
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