Page History
...
The DM domain includes required variables that are often not directly collected on the Demography CRF. This data is populated using other sponsor sources of information. There is a guidance on FDA expectations for and recommendations on use of a standardized approach for collecting and reporting race and ethnicity data in submissions for clinical trials (https://www.fda.gov/regulatory-information/-race-and-ethnicity-data-clinical-trials.
...
Overview
Content Tools