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The Demography domain (DM) is a a special-purpose domain that includes a set of essential standard variables that describe each subject in a study. Companies use different methods to distinguish sites and investigators. CDISC assumes that SITEID will always be present, with INVID and INVNAM used as necessary. Every subject in a study must have a subject identifier (SUBJID). In some cases a subject may participate in more than 1 study. To identify a subject uniquely across all studies for all applications or submissions involving the product, a unique identifier (USUBJID) must be included in all datasets. 

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.

Demographic information is collected about subjects in all 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. .