This is an example demography CRF where the applicant collected information about a subject's race and ethnicity.
The applicant collected the Race and Ethnicity values listed in the FDA guidance on collecting race and ethnicity. Additionally, this applicant collected more details for subjects who reported ASIAN or BLACK OR AFRICAN AMERICAN for Race. When multiple races were self reported, the applicant recorded "MULTIPLE" as the Race and used Supplemental Qualifiers to record the self-reported race. In order to save space, some of the example permissible values are only shown in the metadata specifications.
Applicants may append a suffix to denote multiple collected races and ethnicities (e.g. RACE1, RACE2, CRACE1, CRACE2, CETHNIC1, CETHNIC2). The appended suffixes shown for the CDASH variables QNAM and QLABEL in this aCRF are only examples and are not indicative of any prescribed values that must be followed.
TIG_eCRF_Package_Demography