Versions Compared

Key

  • This line was added.
  • This line was removed.
  • Formatting was changed.

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. 

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 question. When multiple races were self reported, the sponsor recorded "MULTIPLE" as the Race and used Supplemental Qualifiers to record the race self reported. The sponsor also collected more details associated with selected Race categories  These collected race were also reported as Supplemental Qualifiers

...

titleDemographics Sample aCRF for Race with Additional Granularity

    

...

Title : Study Participants Self-reported Race 

...

If the study participant answered: ASIAN

...

ASIAN AMERICAN; ASIAN INDIAN; BANGLADESHI;  CHINESE; JAPANESE; KOREAN;

...

If the study participant answered: BLACK OR AFRICAN AMERICAN 

...

AFRICAN; AFRICAN AMERICAN; AFRICAN CARIBBEAN; BAHAMIAN; BARBADIAN; BLACK; BLACK CENTRAL AMERICAN;

...

This is an example SDTM dataset.  

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 sponsor also collected more details associated with selected Race categories  These collected race were also reported as Supplemental QualifiersNote that this SDTM dataset includes information that is expected to be provided, but not usually collected directly on the Demography CRF.  RFSTDTC, RFENDTC, RFXSTDTC, RFXENDTC, RFCSTDTC, RFCENDTC, RFICDTC -reported race. 

Dataset wrap
Namedm
Dataset2
RowSTUDYIDDOMAINUSUBJIDSUBJIDRFSTDTCRFENDTCRFXSTDTCRFXENDTCRFICDTCRFPENDTCDTHDTCDTHFLSITEIDINVNAMBRTHDTCAGEAGEUSEXRACEETHNICARMCDARMACTARMCDACTARMARMNRSACTARMUDCOUNTRY
1ABC123DMABC12301001ABC123-00010100100012006-0110-121120062007-0301-102006-0110-121120062007-0301-102006-0110-0320062007-0402-01

01JOHNSON, M1948-12-1357YEARSMWHITENOT HISPANIC OR LATINOADrug Product AADrug Product A

USA
2ABC123DMABC12301002ABC123-00020100200022006-01-152006-02-282006-01-152006-02-282006-01-042006-03-26

01JOHNSON, M1955-03-2250YEARSMWHITENOT HISPANIC OR LATINOPBPlaceboProduct BPBPlaceboProduct B

USA
3ABC123DMABC12301003ABC123-00030100300032006-01-162006-03-192006-01-162006-03-192006-01-022006-03-19

01JOHNSON, M1938-01-1968YEARSFBLACK OR AFRICAN AMERICANNOT HISPANIC OR LATINOPBPlaceboProduct BPBPlaceboProduct B

USA
4ABC123DMABC12301004ABC123-0004010040004



2006-01-072006-01-08

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



SCREEN FAILURE
USA
5ABC123DMABC12302001ABC123-20010200120012006-02-022006-03-312006-02-022006-03-312006-01-152006-04-12

02GONZALEZ, E1950-06-2355YEARSFAMERICAN INDIAN OR ALASKA NATIVENOT HISPANIC OR LATINOPBPlaceboProduct BPBPlaceboProduct B

USA
6ABC123DMABC12302002ABC123-20020200220022006-02-032006-04-052006-02-032006-04-052006-01-102006-04-25

02GONZALEZ, E1956-05-0549YEARSFNATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERSNOT HISPANIC OR LATINOADrug Product AADrug Product A

USA
7ABC123DMABC12302003ABC123-2003020032003



2006-02-072006-02-08

0103GONZALEZ, E1945-04-06FMULTIPLENOT HISPANIC OR LATINO



SCREEN FAILURE
USA
Dataset wrap
Namesuppdm
Rowcaps
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.     
BLACK OR AFRICAN AMERICAN
Dataset2
RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIGQEVAL
1ABC123DM
ABC12301004
ABC123-0004
CRACE3


CRACE9Collected Race
3
9JAPANESECRF
2ABC123DM
ABC12301003
ABC123-0003
CRACE5


CRACE12Collected Race
5
12AFRICAN AMERICANCRF
3ABC123DM
ABC12302003
ABC123-2003
CRACE8


RACE5

Collected

Race

8

5

BLACK
WHITECRF
4ABC123DM
ABC12302003
ABC123-2003

RACE1

Race 1

WHITECRF5ABC123DMABC12302003

RACE2

Race 2

AMERICAN INDIAN OR ALASKA NATIVECRF