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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
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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 datset includes information that is expected to be provided, but not usually collect directly on the Demography CRFThis 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 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 | 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 | 1950-06-2355 | 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 | 1956-05-0549 | 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 | DM | ABC123-2003 | 2003 |
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| 2006-02-07 | 2006-02-08 |
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| 03 | 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 ABC789-010-001 USUBJID ABC123-0004 selected "JAPANESE" as the specific ASIAN race collected. | | Row 2: | Shows USUBJID ABC789-010-002 USUBJID ABC123-0003 selected "AFRICAN AMERICAN" as the specific BLACK OR AFRICAN AMERICAN race collected. | | Row Rows 3-4: | Shows USUBJID ABC789-010-003 selected "BLACKShow USUBJID ABC123-2003 specified "AMERICAN INDIAN OR ALASKA NATIVE" and "WHITE " as the specific BLACK OR AFRICAN AMERICAN race collected. |
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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 |
ABC789ABC789010-001CRACE3 3ABC789ABC789010-002CRACE5 5ABC789ABC789-010-003 | | | BLACK| ABC123-2003 |
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| | | WHITE | CRF |
| | 4 | ABC123 | DM | ABC123-2003 |
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| | | AMERICAN INDIAN OR ALASKA NATIVE | CRF |
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