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.

Demographic information is collected about subjects in all clinical studies. The amount of demographic information collected will be determined by the analysis needs of the study and regulatory requirements, and may be affected by local restrictions related to data privacy. .

...