Collection of Race and Ethnicity Data in Clinical Trials: Guidance for Industry and Food and Drug Administration Staff | Guideline Explorer

Description

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.

Scope & Applicability

Product Classes

1

Medical Device

FDA intends to assess device cybersecurity based on a number of factors; demonstrate or maintain its safety and effectiveness; ensuring cybersecurity has become essential to FDA’s ability to protect the public health; Cyber-resiliency capabilities for medical devices

Stakeholders

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Sponsor

Entity responsible for submitting applications under section 524B