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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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 questionThis is an example SDTM dataset. 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 sponsor recorded applicant recorded "MULTIPLE" as the Race and used Supplemental Qualifiers to record the race self reported. The sponosr also collected more details when a race ..
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title | Demographics Sample aCRF for Race with Additional Granularity |
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-reported
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race
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If the study participant answered: ASIAN
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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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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 | BRTHDTC | AGE | 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 | 1948-12-1357 | 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 | 1955-03-22 | 50 | 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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