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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, and for subjects who self-reported ethnicity as Hispanic/Latino.    

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
1What is the subject's year of birth?Birth DateRecord the subject's year of birth (e.g., YYYY, a 4-digit year).BRTHDATBRTHDTCBRTHDAT



2What is the sex of the subject?SexRecord the appropriate sex (e.g., Female, Male).SEXSEXSEX(SEX)Male; Female; Unknown; Undifferentiated

3Do you consider yourself Hispanic/Latino or not Hispanic/Latino?EthnicityRecord the participants self-report ethnicity, ETHNICETHNICETHNIC(ETHNIC)Hispanic or Latino; Not Hispanic or Latino; Not Reported

4 What is the ethnicity of the subject? (More than 1 choice is acceptable.)EthnicityFor a subject who self-reported ethnicity as Hispanic or Latino, Select each value that applies to the subject.   CETHNIC(n)SUPPDM.QVALSUPPDM.QVAL where SUPPDM.QNAM = ETHNIC(n)  and SUPPDM.QLABEL = Collected Ethnicity (n) (ETHNICC)

CENTRAL AMERICAN ; CUBAN AMERICAN; LATIN AMERICAN; MEXICAN; MEXICAN AMERICAN;PUERTO RICAN;SOUTH AMERICAN ; SPANISH




5

Which of the following racial designations best describes you? (More than 1 choice is acceptable.)

RaceRecord the participant self-report race, RACE(n)RACERACE(n)(RACE)AMERICAN INDIAN OR ALASKA NATIVE;ASIAN;BLACK OR AFRICAN AMERICAN;NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER; WHITE;NOT REPORTED;UNKNOWN








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