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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 subjects who self-reported ethnicity as Hispanic/Latino.
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Sponsors may append a suffix to denote multiple collected races and ethnicities (e.g. RACE1, RACE2, CRACE1, CRACE2, CETHNIC1, CETHNIC2). These are only examples and are not indicative of any prescribed values that must be followed. |
The sponsor allowed subjects 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 | aCRF: Demography with Self-reported Race and Ethnicity |
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Title : Demography with detail Self-reported Race and Ethnicity collection
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CENTRAL AMERICAN ; CUBAN AMERICAN; LATIN AMERICAN; MEXICAN; MEXICAN AMERICAN;PUERTO RICAN;SOUTH AMERICAN ; SPANISH
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Which of the following racial designations best describes you? (More than 1 choice is acceptable.)
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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 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.
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