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This is an example demography CRF where the sponsor collected information about a subject's race and ethnicity. The sponsor collected the Race and Ethnicity values listed in the FDA guidance on collecting race and ethnicity. Additionally, this sponsor  collected more details for subject who reported ASIAN or BLACK OR AFRICAN AMERICAN for Race, and for subject who self-reported ethnicity as Hispanic/Latino.    

The sponsor allowed subject to record multiple answers to the Race question. When multiple races were self reported, the sponsor recorded "MULTIPLE" as the Race and used Supplemental Qualifiers to record the self-reported race. 

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Title : Demography with detail Self-reported Race and Ethnicity collection     

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SDTM

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

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If the study participant answered: ASIAN

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

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If the study participant answered: BLACK OR AFRICAN AMERICAN 

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

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This is an example SDTM dataset.   This SDTM dataset includes information that is expected to be provided, but not usually collected directly on the Demography CRF. This includes  includes RFSTDTC, RFENDTC, RFXSTDTC, RFXENDTC, RFCSTDTC, RFCENDTC, RFICDTC. DTHDTC and DTHFL are also expected to be included. For a subject who has not died, the value of variable DTHF is null. The death date may be blank if unknown. When multiple races were self reported, the applicant recorded "MULTIPLE" as the Race and used Supplemental Qualifiers to record the self-reported race.