Collection of Race and Ethnicity Data in Clinical Trials: Guidance for Industry and Food and Drug Administration Staff
Information
Type
Guidance
Regulated products
Biologics, Drugs, Medical Devices
Topics
Clinical - Medical, Good Clinical Practice (GCP), Investigational Device Exemption (IDE)
Published
October 26, 2016
Last updated
August 10, 2023
Description
Guidance document on collecting race and ethnicity data in clinical trials, aimed at industry and FDA staff. Covers GCP and IDE topics.
Tags
Organization
Country / Region
United States
License
Other (Public Domain)