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Financial Disclosure by Clinical Investigators Guidance for Clinical Investigators, Industry,and FDA Staff February 2013

Issued by:
Guidance Issuing Office
Office of the Commissioner,Office of Clinical Policy and Programs,Office of Clinical Policy,Office of Good Clinical Practice
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research

This guidance is intended to assist clinical investigators, industry, and FDA staff in interpreting and complying with the regulations governing financial disclosure by clinical investigators, 21 CFR part 54.  This document is a revision of the Guidance for Industry: Financial Disclosure by Clinical Investigators dated March 20, 2001.  In order to address issues raised by the Office of the Inspector General (OIG), Department of Health and Human Services, in its report, OEI-05-07-00730, The Food and Drug Administration’s Oversight of Clinical Investigators’ Financial Information as well as questions FDA has received from industry and the public, FDA issued a revised guidance in draft in May 2011 for public comment.  Comments were received from 13 individuals and entities, which were considered in preparing this final guidance.  FDA encourages applicants and sponsors to contact the agency for advice concerning specific circumstances regarding financial disclosures that may raise concerns as early in the product development process as possible. 

Submit Comments

Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.

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