You are viewing an old version of this page. View the current version.

Compare with Current View Page History

« Previous Version 11 Next »

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 sponosr also collected more details when a race ..    

    

Title : Study Participants Self-reported Race 

Record the subject's year of birth (e.g., YYYY, a 4-digit year).
BRTHDAT BRTHDTC
_________________
Record the appropriate sex (e.g., Female, Male).What is the sex of the subject?
SEX
<SEX codelist>
Study participants should self-report ethnicity, with ethnicity being asked about before race.Do you consider yourself Hispanic/Latino or not Hispanic/Latino?
ETHNIC
<ETHNIC codelist>
Select each value that applies to the subjectWhat is the ethnicity of the subject?
CETHNIC(n) SUPPDM.QVAL where SUPPDM.QNAM = ETHNIC(n) and SUPPDM.QLABEL = Collected Ethnicity (n)
<ETHNICC codelist>
Study participants should self-report race, with race being asked about after ethnicity. (More than 1 choice is acceptable.)Which of the following racial designations best describes you? (Check all that apply
RACE(n) RACE
<RACE codelist>
CDASH VariableOrderQuestion TextPromptCRF Completion InstructionsTypeSDTMIG Target VariableSDTM Target MappingControlled Terminology Code List NamePermissible ValuesPre-specified ValueQuery DisplayList StyleHidden
BRTHDAT1What is the subject's year of birth?Birth DateRecord the subject's year of birth (e.g., YYYY, a 4-digit year).TextBRTHDTC






SEX2What is the sex of the subject?SexRecord the appropriate sex (e.g., Female, Male).TextSEX
(SEX)Male; Female; Unknown; Undifferentiated

radio
ETHNIC3Do you consider yourself Hispanic/Latino or not Hispanic/Latino?EthnicityStudy participants should self-report ethnicity, with ethnicity being asked about before race.TextETHNIC
(ETHNIC)Hispanic or Latino; Not Hispanic or Latino; Not Reported

radio
CETHNIC(n)4What is the ethnicity of the subject?EthnicitySelect each value that applies to the subject  TextSUPPDM.QVALSUPPDM.QVAL where SUPPDM.QNAM = ETHNIC(n)  and SUPPDM.QLABEL = Collected Ethnicity (n) (ETHNICC)Add the long list 

checkbox
RACE(n)5Which of the following racial designations best describes you? (Check all that apply RaceStudy participants should self-report race, with race being asked about after ethnicity. (More than 1 choice is acceptable.)TextRACE
(RACE)
  • American Indian or Alaska Native:
  • Asian;
  • Black or African American;
  • Native Hawaiian or Other Pacific Islander;
  • White; UNKNOWN:
    OTHER:




checkbox

If the study participant answered: ASIAN

Select each value that applies if the subject answered "ASIAN". Check all that apply.Which of the following racial designations best describes you?
CRACE05-CRACE10 For each value that applies, SUPPDM.QVAL where SUPPDM.QNAM ="CRACEn" and SUPPDM.QLABEL = "Collected Race n" where n is the choice value.
<RACEC codelist>
CDASH VariableOrderQuestion TextPromptCRF Completion InstructionsTypeSDTMIG Target VariableSDTM Target MappingControlled Terminology Code List NamePermissible ValuesPre-specified ValueQuery DisplayList StyleHidden
CRACE05-CRACE1011Which of the following racial designations best describes you? RaceSelect each value that applies if the subject answered "ASIAN". Check all that apply.TextSUPPDM.QVALFor each value that applies, SUPPDM.QVAL where SUPPDM.QNAM ="CRACEn" and SUPPDM.QLABEL = "Collected Race n" where n is the choice value.(RACEC)

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




checkbox

If the study participant answered: BLACK OR AFRICAN AMERICAN 

Select each value that applies if the subject answered "BLACK OR AFRICAN AMERICAN". Check all that apply.Which of the following racial designations best describes you?
CRACE11-CRACE17 For each value that applies, SUPPDM.QVAL where SUPPDM.QNAM ="CRACEn" and SUPPDM.QLABEL = "Collected Race n" where n is the choice value.
<RACEC codelist>
CDASH VariableOrderQuestion TextPromptCRF Completion InstructionsTypeSDTMIG Target VariableSDTM Target MappingControlled Terminology Code List NamePermissible ValuesPre-specified ValueQuery DisplayList StyleHidden
CRACE11-CRACE1712Which of the following racial designations best describes you? RaceSelect each value that applies if the subject answered "BLACK OR AFRICAN AMERICAN". Check all that apply.TextSUPPDM.QVALFor each value that applies, SUPPDM.QVAL where SUPPDM.QNAM ="CRACEn" and SUPPDM.QLABEL = "Collected Race n" where n is the choice value.(RACEC)

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




checkbox

This is an example SDTM dataset.  Note 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

dm.xpt

dm.xpt

RowSTUDYIDDOMAINUSUBJIDSUBJIDRFSTDTCRFENDTCRFXSTDTCRFXENDTCRFICDTCRFPENDTCSITEIDINVNAMBRTHDTCAGEAGEUSEXRACEETHNICARMCDARMACTARMCDACTARMARMNRSACTARMUDCOUNTRY
1ABC123DMABC12301001010012006-01-122006-03-102006-01-122006-03-102006-01-032006-04-0101JOHNSON, M1948-12-1357YEARSMWHITEHISPANIC OR LATINOADrug AADrug A

USA
2ABC123DMABC12301002010022006-01-152006-02-282006-01-152006-02-282006-01-042006-03-2601JOHNSON, M1955-03-2250YEARSMWHITENOT HISPANIC OR LATINOPPlaceboPPlacebo

USA
3ABC123DMABC12301003010032006-01-162006-03-192006-01-162006-03-192006-01-022006-03-1901JOHNSON, M1938-01-1968YEARSFBLACK OR AFRICAN AMERICANNOT HISPANIC OR LATINOPPlaceboPPlacebo

USA
4ABC123DMABC1230100401004



2006-01-072006-01-0801JOHNSON, M1941-07-02

MASIANNOT HISPANIC OR LATINO



SCREEN FAILURE
USA
5ABC123DMABC12302001020012006-02-022006-03-312006-02-022006-03-312006-01-152006-04-1202GONZALEZ, E1950-06-2355YEARSFAMERICAN INDIAN OR ALASKA NATIVENOT HISPANIC OR LATINOPPlaceboPPlacebo

USA
6ABC123DMABC12302002020022006-02-032006-04-052006-02-032006-04-052006-01-102006-04-2502GONZALEZ, E1956-05-0549YEARSFNATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERSNOT HISPANIC OR LATINOADrug AADrug A

USA
7ABC123DMABC1230200302003



2006-02-072006-02-0801GONZALEZ, E1945-04-06

FMULTIPLENOT HISPANIC OR LATINO



SCREEN FAILURE
USA
$warningHtml

Row 1:Shows USUBJID ABC12301004 selected "JAPANESE" as the specific ASIAN race collected.
Row 2:Shows USUBJID ABC12301003 selected "AFRICAN AMERICAN" as the specific BLACK OR AFRICAN AMERICAN race collected.
Row 3:Shows USUBJID ABC12302003 specified " BLACK OR AFRICAN AMERICAN and "WHITE " as the race.
$titleHtml

suppdm.xpt

RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIGQEVAL
1ABC123DMABC12301004

CRACE3Collected Race 3JAPANESECRF
2ABC123DMABC12301003

CRACE5Collected Race 5AFRICAN AMERICANCRF
3ABC123DMABC12302003

CRACE8

Collected Race 8

BLACKCRF
4ABC123DMABC12302003

RACE1

Race 1

WHITECRF
5ABC123DMABC12302003

RACE2

Race 2

BLACK OR AFRICAN AMERICANCRF
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

  • No labels