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.
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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. Note that this SDTM 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 applicant recorded "MULTIPLE" as the Race and used Supplemental Qualifiers to record the self-reported race.
Dataset wrap |
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Dataset2 |
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Row | STUDYID | DOMAIN | USUBJID | SUBJID | RFSTDTC | RFENDTC | RFXSTDTC | RFXENDTC | RFICDTC | RFPENDTC | DTHDTC | DTHFL | SITEID | INVNAM | BRTHDTCAGE | AGEU | SEX | RACE | ETHNIC | ARMCD | ARM | ACTARMCD | ACTARM | ARMNRS | ACTARMUD | COUNTRY |
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1 | ABC123 | DMABC12301001 | ABC123-0001 | 010010001 | 2006-0110-1211 | 20062007-0301-10 | 2006-0110-1211 | 20062007-0301-10 | 2006-0110-03 | 20062007-0402-01 |
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| 01 | JOHNSON, M | 1948-12-13 | 57 | YEARS | M | WHITE | NOT HISPANIC OR LATINO | ADrug | Product A | ADrug | Product A |
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| USA | 2 | ABC123 | DMABC12301002 | ABC123-0002 | 010020002 | 2006-01-15 | 2006-02-28 | 2006-01-15 | 2006-02-28 | 2006-01-04 | 2006-03-26 |
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| 01 | JOHNSON, M | 1955-03-2250 | YEARS | M | WHITE | NOT HISPANIC OR LATINO | PB | PlaceboProduct B | PB | PlaceboProduct B |
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| USA | 3 | ABC123 | DMABC12301003 | ABC123-0003 | 010030003 | 2006-01-16 | 2006-03-19 | 2006-01-16 | 2006-03-19 | 2006-01-02 | 2006-03-19 |
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| 01 | JOHNSON, M | 1938-01-19 | 68 | YEARS | F | BLACK OR AFRICAN AMERICAN | NOT HISPANIC OR LATINO | PB | PlaceboProduct B | PB | PlaceboProduct B |
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| USA | 4 | ABC123 | DMABC12301004 | ABC123-0004 | 010040004 |
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| 2006-01-07 | 2006-01-08 |
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| 01 | JOHNSON, M | 1941-07-02 | M | ASIAN | NOT HISPANIC OR LATINO |
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| SCREEN FAILURE |
| USA | 5 | ABC123 | DMABC12302001 | ABC123-2001 | 020012001 | 2006-02-02 | 2006-03-31 | 2006-02-02 | 2006-03-31 | 2006-01-15 | 2006-04-12 |
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| 02 | GONZALEZ, E | 1950-06-23 | 55 | YEARS | F | AMERICAN INDIAN OR ALASKA NATIVE | NOT HISPANIC OR LATINO | PB | PlaceboProduct B | PB | PlaceboProduct B |
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| USA | 6 | ABC123 | DMABC12302002 | ABC123-2002 | 020022002 | 2006-02-03 | 2006-04-05 | 2006-02-03 | 2006-04-05 | 2006-01-10 | 2006-04-25 |
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| 02 | GONZALEZ, E | 1956-05-05 | 49 | YEARS | F | NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERS | NOT HISPANIC OR LATINO | ADrug | Product A | ADrug | Product A |
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| USA | 7 | ABC123 | DMABC12302003 | ABC123-2003 | 020032003 |
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| 2006-02-07 | 2006-02-08 |
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| 0103 | GONZALEZ, E | 1945-04-06 | F | MULTIPLE | NOT HISPANIC OR LATINO |
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| SCREEN FAILURE |
| USA |
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Dataset wrap |
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Rowcaps |
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Row 1: | Shows USUBJID ABC12301004 ABC123-0004 selected "JAPANESE" as the specific ASIAN race collected. | Row 2: | Shows USUBJID ABC12301003 ABC123-0003 selected "AFRICAN AMERICAN" as the specific BLACK OR AFRICAN AMERICAN race collected. | Row Rows 3-4: | Shows Show USUBJID ABC12302003 ABC123-2003 specified " BLACK OR AFRICAN AMERICAN AMERICAN INDIAN OR ALASKA NATIVE" and "WHITE " as the race. |
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Dataset2 |
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Row | STUDYID | RDOMAIN | USUBJID | IDVAR | IDVARVAL | QNAM | QLABEL | QVAL | QORIG | QEVAL |
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1 | ABC123 | DM | ABC12301004CRACE3 3ABC12301003CRACE5 512 | AFRICAN AMERICAN | CRF |
| 3 | ABC123 | DM | ABC12302003CRACE8Collected 8BLACKABC12302003WHITE | CRF | 5 | ABC123 | DM | ABC12302003 | | | BLACK OR AFRICAN AMERICANAMERICAN INDIAN OR ALASKA NATIVE | CRF |
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