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US FDA Outlines Format For Race, Ethnicity Data Collection

 
• By Elizabeth Orr

The guidance document tells sponsors to ask about ethnicity before race, and provides suggested wording. It updates a 2005 guidance.

Sponsors should use a two-question format to collect race and ethnicity data during clinical trials, US FDA explained in a newly updated guidance document.

The document, dated Oct. 26, is an update to 2005 policy. The agency considers it a "Level 2" guidance, meaning it addresses existing policy and does not need to be...

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