This 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.
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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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| 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 SDTM dataset
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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 | 1948-12-13 | 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 | 1955-03-22 | 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 | A | Drug A | 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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| 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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