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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. When multiple races were self reported, the sponsor recorded "MULTIPLE" as the Race and used Supplemental Qualifiers to record the self-reported race. In order to save space, some of the 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.


Section 1 

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).DateBRTHDTCBRTHDAT



2What is the sex of the subject?SexRecord the appropriate sex (e.g., Female, Male).TextSEXSEX
(SEX)Male; Female; Unknown; Undifferentiated
3Do you consider yourself Hispanic/Latino or not Hispanic/Latino?EthnicityRecord the participants self-report ethnicity, TextETHNICETHNIC
(ETHNIC)Hispanic or Latino; Not Hispanic or Latino; Not Reported
4

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

RaceRecord the participant self-report race, TextRACE1-RACE6RACE SUPPDM.QVALRACE or RACE="MULTIPLE" and each Race is represented as a SUPPDM.QVAL where SUPPDM.QNAM = RACE(n)  and SUPPDM.QLABEL = Race (n) (RACE)AMERICAN INDIAN OR ALASKA NATIVE;ASIAN;BLACK OR AFRICAN AMERICAN;NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER; WHITE;NOT REPORTED;UNKNOWN

Section 2:  If the study participant answered: ASIAN or "BLACK OR AFRICAN AMERICAN.

OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
5Which of the following racial designations best describes you? (More than 1 choice is acceptable.)RaceIf the subject answered "ASIAN" Select each value that applies.  TextCRACE05-CRACE10SUPPDM.QVALFor each value that applies, SUPPDM.QVAL where SUPPDM.QNAM ="CRACEn" and SUPPDM.QLABEL = "Collected Race n" where n is the choice value.

ASIAN AMERICAN; ASIAN INDIAN; BANGLADESHI;  CHINESE; JAPANESE; KOREAN;



6Which of the following racial designations best describes you? (More than 1 choice is acceptable.)RaceIf the subject answered "BLACK OR AFRICAN AMERICAN".Select each value that applies.  TextCRACE11-CRACE17SUPPDM.QVALFor each value that applies, SUPPDM.QVAL where SUPPDM.QNAM ="CBACEn" and SUPPDM.QLABEL = "Collected Race n" where n is the choice value.

AFRICAN; AFRICAN AMERICAN; AFRICAN CARIBBEAN; BAHAMIAN; BARBADIAN; BLACK; BLACK CENTRAL AMERICAN;





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