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  1.  Example of DM with the variables used to describe some key features of the study. 
  2. Example: Collects Collect race, and FDA RAC/Ethnicity categories 

    

Title : Study Participants Self-reported Race 

Study participants should self-report race, with race being asked about after ethnicity.Which of the following racial designations best describes you? (Check all that apply
RACE0(n) RACE
<RACE codelist>
CDASH VariableOrderQuestion TextPromptCRF Completion InstructionsTypeSDTMIG Target VariableSDTM Target MappingControlled Terminology Code List NamePermissible ValuesPre-specified ValueQuery DisplayList StyleHidden
RACE0(n)1Which 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.TextRACE
(RACE)

WHITE;

BLACK OR AFRICAN AMERICAN ;

AMERICAN INDIAN OR ALASKA NATIVE;



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

Row 1:Shows that USUBJID ABC789-010-001 designated 1 race, "ASIAN", as the value that best describes their race.
Row 2:Shows that USUBJID ABC789-010-002 designated 1 race, "BLACK OR AFRICAN AMERICAN", as the value that best describes their race.
Row 3:Shows that USUBJID ABC789-010-003 designated 1 race, "BLACK OR AFRICAN AMERICAN", as the value that best describes their race.

dm.xpt

dm.xpt

RowSTUDYIDDOMAINUSUBJIDSUBJIDRACE
1ABC789DMABC789-010-001010-001ASIAN
2ABC789DMABC789-010-002010-002BLACK OR AFRICAN AMERICAN
3ABC789DMABC789-010-003010-003BLACK OR AFRICAN AMERICAN
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.


This SDTM dataset 


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
$warningHtml

Row 1:Shows USUBJID ABC789-010-001 selected "JAPANESE" as the specific ASIAN race collected.
Row 2:Shows USUBJID ABC789-010-002 selected "AFRICAN AMERICAN" as the specific BLACK OR AFRICAN AMERICAN race collected.
Row 3:Shows USUBJID ABC789-010-003 selected "BLACK" as the specific BLACK OR AFRICAN AMERICAN race collected.
$titleHtml

suppdm.xpt

RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIGQEVAL
1ABC789DMABC789-010-001

CRACE3Collected Race 3JAPANESECRF
2ABC789DMABC789-010-002

CRACE5Collected Race 5AFRICAN AMERICANCRF
3ABC789DMABC789-010-003

CRACE8

Collected Race 8

BLACKCRF
$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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