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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. 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. 

The DM domain includes required variables that are often not directly collected on the Demography CRF. This data is populated using other sponsor sources of information. There is a guidance on FDA expectations for and recommendations on use of a standardized approach for collecting and reporting race and ethnicity data in submissions for clinical trials (https://www.fda.gov/regulatory-information/-race-and-ethnicity-data-clinical-trials.

Example

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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. 

dm.xpt

dm.xpt

RowSTUDYIDDOMAINUSUBJIDSUBJIDRFSTDTCRFENDTCRFXSTDTCRFXENDTCRFICDTCRFPENDTCDTHDTCDTHFLSITEIDINVNAMBRTHDTCSEXRACEETHNICARMCDARMACTARMCDACTARMARMNRSACTARMUDCOUNTRY
1ABC123DMABC123-000100012006-10-112007-01-102006-10-112007-01-102006-10-032007-02-01

01JOHNSON, M1948-12-13MWHITENOT HISPANIC OR LATINOAProduct AAProduct A

USA
2ABC123DMABC123-000200022006-01-152006-02-282006-01-152006-02-282006-01-042006-03-26

01JOHNSON, M1955-03-22MWHITENOT HISPANIC OR LATINOBProduct BBProduct B

USA
3ABC123DMABC123-000300032006-01-162006-03-192006-01-162006-03-192006-01-022006-03-19

01JOHNSON, M1938-01-19FBLACK OR AFRICAN AMERICANNOT HISPANIC OR LATINOBProduct BBProduct B

USA
4ABC123DMABC123-00040004



2006-01-072006-01-08

01JOHNSON, M1941-07-02MASIANNOT HISPANIC OR LATINO



SCREEN FAILURE
USA
5ABC123DMABC123-200120012006-02-022006-03-312006-02-022006-03-312006-01-152006-04-12

02GONZALEZ, E1950-06-23FAMERICAN INDIAN OR ALASKA NATIVENOT HISPANIC OR LATINOBProduct BBProduct B

USA
6ABC123DMABC123-200220022006-02-032006-04-052006-02-032006-04-052006-01-102006-04-25

02GONZALEZ, E1956-05-05FNATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERSNOT HISPANIC OR LATINOAProduct AAProduct A

USA
7ABC123DMABC123-20032003



2006-02-072006-02-08

03GONZALEZ, E1945-04-06FMULTIPLENOT HISPANIC OR LATINO



SCREEN FAILURE
USA
$warningHtml

Row 1:Shows USUBJID ABC123-0004 selected "JAPANESE" as the specific ASIAN race collected.
Row 2:Shows USUBJID ABC123-0003 selected "AFRICAN AMERICAN" as the specific BLACK OR AFRICAN AMERICAN race collected.
Rows 3-4:Show USUBJID ABC123-2003 specified "AMERICAN INDIAN OR ALASKA NATIVE" and "WHITE " as the race.
$titleHtml

suppdm.xpt

RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIGQEVAL
1ABC123DMABC123-0004

CRACE9Collected Race 9JAPANESECRF
2ABC123DMABC123-0003

CRACE12Collected Race 12AFRICAN AMERICANCRF
3ABC123DMABC123-2003

RACE5

Race 5

WHITECRF
4ABC123DMABC123-2003

RACE1

Race 1

AMERICAN INDIAN OR ALASKA NATIVECRF
$warningHtml

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