The CDASHIG Demographics (DM) domain includes essential data collection fields that describe each subject in a clinical study. The collection of some demographics data is useful to perform simple analyses based upon population stratification.
DMDAT is used to collect the date demographics information was collected. The manner of populating this field will depend on how the EDC system is set up. For this example, the field will be manually populated on the form.
In cases where a specific population will require more information to be collected in demographics, the name of the demographics form may be updated to identify a version of a standard demographics form. For example, pediatrics populations may need to collect age using the number of weeks or hours. Thus, the form may be named 'DM_PEDS'.
This DM form is US centric, for studies conducted outside of the US, the form may need to be updated.
DM eCRF Package