The purpose of Considerations for Race and Ethnicity Data in Clinical Trials is to provide Study Data Tabulation Model (SDTM) implementation advice for sponsors wishing to comply with the U.S. Food and Drug Administration (FDA) Guidance on Collection of Race and Ethnicity Data in Clinical Trials. Recommendations provided in the document are considered to be informative, aiding parties implementing race and ethnicity data collection in a consistent and methodical approach. This document is not a substitute for, nor a comprehensive reference of, the FDA Guidance. Therefore, it is recommended to thoroughly review the FDA Guidance prior to referencing the document.
CDISC relies on your input to ensure neutral, consensus-based data standards are developed and adopted by a diverse global community interested in improving research processes and quality for the benefit of all.
View the draft: Considerations for Race and Ethnicity Data in Clinical Trials
You will need to log in or register for the CDISC Wiki to provide comments.
CDISC Wiki is a different login from www.cdisc.org.