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 | Xformpusher |
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| CDASH Variable | Order | Question Text | Prompt | CRF Completion Instructions | Type | SDTMIG Target Variable | SDTM Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-specified Value | Query Display | List Style | Hidden | | BRTHDAT | 1 | What is the subject's year of birth? | Birth Date | Record the subject's year of birth (e.g., YYYY, a 4-digit year). | Text | BRTHDTC |
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| | SEX | 2 | What is the sex of the subject? | Sex | Record the appropriate sex (e.g., Female, Male). | Text | SEX |
| (SEX) | Male; Female; Unknown; Undifferentiated |
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| | ETHNIC | 3 | Do you consider yourself Hispanic/Latino or not Hispanic/Latino? | Ethnicity | Study participants should self-report ethnicity, with ethnicity being asked about before race. | Text | ETHNIC |
| (ETHNIC) | Hispanic or Latino; Not Hispanic or Latino; Not Reported |
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| | CETHNIC(n) | 4 | What is the ethnicity of the subject? | Ethnicity | Select each value that applies to the subject | Text | SUPPDM.QVAL | SUPPDM.QVAL where SUPPDM.QNAM = ETHNIC(n) and SUPPDM.QLABEL = Collected Ethnicity (n) | (ETHNICC) | Add the long list |
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| | RACE(n) | 5 | Which of the following racial designations best describes you? (Check all that apply | Race | Study participants should self-report race, with race being asked about after ethnicity. (More than 1 choice is acceptable.) | Text | RACE |
| (RACE) | - American Indian or Alaska Native:
- Asian;
- Black or African American;
- Native Hawaiian or Other Pacific Islander;
- White; UNKNOWN:
OTHER:
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If the study participant answered: ASIAN | Xformpusher |
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| CDASH Variable | Order | Question Text | Prompt | CRF Completion Instructions | Type | SDTMIG Target Variable | SDTM Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-specified Value | Query Display | List Style | Hidden | | CRACE05-CRACE10 | 11 | Which of the following racial designations best describes you? | Race | Select each value that applies if the subject answered "ASIAN". Check all that apply. | Text | SUPPDM.QVAL | For each value that applies, SUPPDM.QVAL where SUPPDM.QNAM ="CRACEn" and SUPPDM.QLABEL = "Collected Race n" where n is the choice value. | (RACEC) | ASIAN AMERICAN; ASIAN INDIAN; BANGLADESHI; CHINESE; JAPANESE; KOREAN;
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If the study participant answered: BLACK OR AFRICAN AMERICAN | Xformpusher |
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| CDASH Variable | Order | Question Text | Prompt | CRF Completion Instructions | Type | SDTMIG Target Variable | SDTM Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-specified Value | Query Display | List Style | Hidden | | CRACE11-CRACE17 | 12 | Which of the following racial designations best describes you? | Race | Select each value that applies if the subject answered "BLACK OR AFRICAN AMERICAN". Check all that apply. | Text | SUPPDM.QVAL | For each value that applies, SUPPDM.QVAL where SUPPDM.QNAM ="CRACEn" and SUPPDM.QLABEL = "Collected Race n" where n is the choice value. | (RACEC) | AFRICAN; AFRICAN AMERICAN; AFRICAN CARIBBEAN; BAHAMIAN; BARBADIAN; BLACK; BLACK CENTRAL AMERICAN;
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