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The Demography domain (DM) is a a special-purpose domain that includes a set of essential standard variables that describe each subject in a study. Investigator and site identification: Companies use different methods to distinguish sites and investigators. CDISC assumes that SITEID will always be present, with INVID and INVNAM used as necessary. Every subject in a study must have a subject identifier (SUBJID). In some cases a subject may participate in more than 1 study. To identify a subject uniquely across all studies for all applications or submissions involving the product, a unique identifier (USUBJID) must be included in all datasets.
In this study, the sponsor collected the Race and Ethnicity values listed in the FDA guidance on collecting race and ethnicity data. However, 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 race self reported. The sponsor also collected more details associated with selected Race categories These collected race were also reported as Supplemental Qualifiers
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title | Demographics Sample aCRF for Race with Additional Granularity |
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Title : Study Participants Self-reported Race
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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.
The sponsor collected the Race and Ethnicity values listed in the FDA guidance on collecting race and ethnicity data. However, the sponsor allowed subject to record multiple answers to the Race questionThis is an example SDTM dataset. This 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. When multiple races were self reported, the sponsor recorded applicant recorded "MULTIPLE" as the Race and used Supplemental Qualifiers to record the race self reported. The sponsor also collected more details associated with selected Race categories These collected race were also reported as Supplemental QualifiersNote that this SDTM dataset includes information that is expected to be provided, but not usually collected directly on the Demography CRF. RFSTDTC, RFENDTC, RFXSTDTC, RFXENDTC, RFCSTDTC, RFCENDTC, RFICDTC -reported race.
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