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 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 subject 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 | 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 a subject who self-reported ethnicity as Hispanic or Latino, Select each value that applies to the subject 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 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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