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GUIDANCE DOCUMENT

Collection of Race and Ethnicity Data in Clinical Trials Guidance for Industry and Food and Drug Administration Staff October 2016

Final

This guidance is being distributed for comment purposes only.

Collection of Race and Ethnicity Data in Clinical Trials

Submit Comments by 12/31/2019

Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the FDA considers your comment on a draft guidance before it begins work on the final version of the guidance, submit either online or written comments on the draft guidance before the close date.

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

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2016-D-3561


Docket Number:
FDA-2016-D-3561
Issued by:
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
Center for Biologics Evaluation and Research
Office of Minority Health
Office of Women's Health

The purpose of this guidance is to provide FDA expectations for and recommendations on use of a standardized approach for collecting and reporting race and ethnicity data in submissions for clinical trials for FDA regulated medical products conducted in the United States and abroad. Using standard terminology for age, sex, gender, race, and ethnicity helps ensure that subpopulation data is collected consistently. The recommended standardized approach is based on the Office of Management and Budget (OMB) Directive 15 and developed in accordance with section 4302 of the Affordable Care Act, the HHS Implementation Guidance on Data Collection Standards for Race, Ethnicity, Sex, Primary Language, and Disability Status, and the Food and Drug Administration Safety and Innovation Act (FDASIA) Section 907 Action Plan. This guidance lists the OMB categories for race and ethnicity and describes FDA's reasons for recommending the use of these categories in medical product (drugs, biologics, and devices) applications. In addition, this guidance recommends a format for collection of race and ethnicity clinical trial data that are submitted in standardized data sets per the Study Data Tabulation Model, in the electronic Common Technical Document (eCTD), and as specified in FDA’s Guidance on providing regulatory submissions in electronic format.