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- Example of DM with the variables used to describe some key features of the study.
- Example: Collects Collect race, and FDA RAC/Ethnicity categories
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The Demography domain 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.
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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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| | RACE0(n) | 3 | 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. | 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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| | ETHNIC | 1 | 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) | 2 | 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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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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| Row 1: | Shows that USUBJID ABC789-010-001 designated 1 race, "ASIAN", as the value that best describes their race.
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| Row 2: | Shows that USUBJID ABC789-010-002 designated 1 race, "BLACK OR AFRICAN AMERICAN", as the value that best describes their race. |
| Row 3: | Shows that USUBJID ABC789-010-003 designated 1 race, "BLACK OR AFRICAN AMERICAN", as the value that best describes their race. |
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| Row | STUDYID | DOMAIN | USUBJID | SUBJID | RACE |
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| 1 | ABC789 | DM | ABC789-010-001 | 010-001 | ASIAN |
| 2 | ABC789 | DM | ABC789-010-002 | 010-002 | BLACK OR AFRICAN AMERICAN |
| 3 | ABC789 | DM | ABC789-010-003 | 010-003 | BLACK OR AFRICAN AMERICAN |
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This SDTM dataset This is an example SDTM dataset. Note that this SDTM datset includes information that is expected to be provided, but not usually collect directly on the Demography CRF.
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| Dataset2 |
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| Row | STUDYID | DOMAIN | USUBJID | SUBJID | RFSTDTC | RFENDTC | RFXSTDTC | RFXENDTC | RFICDTC | RFPENDTC | SITEID | INVNAM | BRTHDTC | AGE | AGEU | SEX | RACE | ETHNIC | ARMCD | ARM | ACTARMCD | ACTARM | ARMNRS | ACTARMUD | COUNTRY |
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| 1 | ABC123 | DM | ABC12301001 | 01001 | 2006-01-12 | 2006-03-10 | 2006-01-12 | 2006-03-10 | 2006-01-03 | 2006-04-01 | 01 | JOHNSON, M | 1948-12-13 | 57 | YEARS | M | WHITE | HISPANIC OR LATINO | A | Drug A | A | Drug A |
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| USA | | 2 | ABC123 | DM | ABC12301002 | 01002 | 2006-01-15 | 2006-02-28 | 2006-01-15 | 2006-02-28 | 2006-01-04 | 2006-03-26 | 01 | JOHNSON, M | 1955-03-22 | 50 | YEARS | M | WHITE | NOT HISPANIC OR LATINO | P | Placebo | P | Placebo |
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| USA | | 3 | ABC123 | DM | ABC12301003 | 01003 | 2006-01-16 | 2006-03-19 | 2006-01-16 | 2006-03-19 | 2006-01-02 | 2006-03-19 | 01 | JOHNSON, M | 1938-01-19 | 68 | YEARS | F | BLACK OR AFRICAN AMERICAN | NOT HISPANIC OR LATINO | P | Placebo | P | Placebo |
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| USA | | 4 | ABC123 | DM | ABC12301004 | 01004 |
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| 2006-01-07 | 2006-01-08 | 01 | JOHNSON, M | 1941-07-02 |
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| M | ASIAN | NOT HISPANIC OR LATINO |
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| SCREEN FAILURE |
| USA | | 5 | ABC123 | DM | ABC12302001 | 02001 | 2006-02-02 | 2006-03-31 | 2006-02-02 | 2006-03-31 | 2006-01-15 | 2006-04-12 | 02 | GONZALEZ, E | 1950-06-23 | 55 | YEARS | F | AMERICAN INDIAN OR ALASKA NATIVE | NOT HISPANIC OR LATINO | P | Placebo | P | Placebo |
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| USA | | 6 | ABC123 | DM | ABC12302002 | 02002 | 2006-02-03 | 2006-04-05 | 2006-02-03 | 2006-04-05 | 2006-01-10 | 2006-04-25 | 02 | GONZALEZ, E | 1956-05-05 | 49 | YEARS | F | NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERS | NOT HISPANIC OR LATINO | A | Drug A | A | Drug A |
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| USA |
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