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Sponsors 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 CRF are only examples and are not indicative of any prescribed values that must be followed. |
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 question. When multiple races were self reported, the sponsor recorded "MULTIPLE" as the Race and used Supplemental Qualifiers to record the self-reported race. The sponsor also collected more details associated with those subject that self-reported Race as ASIAN, or selected Race as BLACK OR AFRICAN AMERICAN. These collected details were reported as Supplemental Qualifiers.
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| title | Demography with detail Self-reported Race and Ethnicity collection |
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Title : Demography with detail Self-reported Race and Ethnicity collection | 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 | For subject who self-reported ethnicity as Hispanic or Latino , 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) | CENTRAL AMERICAN ; CUBAN AMERICAN; LATIN AMERICAN; MEXICAN; MEXICAN AMERICAN;PUERTO RICAN;SOUTH AMERICAN ; SPANISH
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| | RACE(n) | 5 | Which of the following racial designations best describes you? (More than 1 choice is acceptable.) | Race | Study participants should self-report race, with race being asked about after ethnicity. | Text | RACE |
| (RACE) | AMERICAN INDIAN OR ALASKA NATIVE;ASIAN;BLACK OR AFRICAN AMERICAN;NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER; WHITE;NOT REPORTED;UNKNOWN |
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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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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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