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This is an example demography CRF where the sponsor collected additional detail about a subject's race and ethnicity. In order to save space, only details were collected for subject who reported ASIAN or BLACK OR AFRICAN AMERICAN for Race, and for subject who self-reported ethnicity as Hispanic/Latino.   

Sponsors may append a suffix to denote multiple collected races and ethnicities (e.g. RACE1, RACE2, CRACE1, CRACE2, CETHNIC1, CETHNIC2). The appended suffixes shown for the CDASH variables QNAM and QLABEL in this CRF are only examples and are not indicative of any prescribed values that must be followed. 

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 self-reported race. The sponsor also collected more details associated with those subject that self-reported Race as ASIAN, or selected Race as BLACK OR AFRICAN AMERICAN. These collected details  were reported as Supplemental Qualifiers.  

    

Title : Demography with detail Self-reported Race and Ethnicity collection     

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>
For subject who self-reported ethnicity as Hispanic or Latino , 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.Which of the following racial designations best describes you? (More than 1 choice is acceptable.)
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)4 What is the ethnicity of the subject?EthnicityFor subject who self-reported ethnicity as Hispanic or Latino , Select each value that applies to the subject  TextSUPPDM.QVALSUPPDM.QVAL where SUPPDM.QNAM = ETHNIC(n)  and SUPPDM.QLABEL = Collected Ethnicity (n) (ETHNICC)

CENTRAL AMERICAN ; CUBAN AMERICAN; LATIN AMERICAN; MEXICAN; MEXICAN AMERICAN;PUERTO RICAN;SOUTH AMERICAN ; SPANISH




checkbox
RACE(n)5

Which of the following racial designations best describes you? (More than 1 choice is acceptable.)

RaceStudy participants should self-report race, with race being asked about after ethnicity.TextRACE
(RACE)AMERICAN INDIAN OR ALASKA NATIVE;ASIAN;BLACK OR AFRICAN AMERICAN;NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER; WHITE;NOT REPORTED;UNKNOWN

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.  This SDTM 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. 

dm.xpt

dm.xpt

RowSTUDYIDDOMAINUSUBJIDSUBJIDRFSTDTCRFENDTCRFXSTDTCRFXENDTCRFICDTCRFPENDTCDTHDTCDTHFLSITEIDINVNAMBRTHDTCAGEAGEUSEXRACEETHNICARMCDARMACTARMCDACTARMARMNRSACTARMUDCOUNTRY
1ABC123DMABC12301001010012006-01-122006-03-102006-01-122006-03-102006-01-032006-04-01

01JOHNSON, M1948-12-1357YEARSMWHITEHISPANIC OR LATINOADrug AADrug A

USA
2ABC123DMABC12301002010022006-01-152006-02-282006-01-152006-02-282006-01-042006-03-26

01JOHNSON, M1955-03-2250YEARSMWHITENOT HISPANIC OR LATINOPPlaceboPPlacebo

USA
3ABC123DMABC12301003010032006-01-162006-03-192006-01-162006-03-192006-01-022006-03-19

01JOHNSON, M1938-01-1968YEARSFBLACK OR AFRICAN AMERICANNOT HISPANIC OR LATINOPPlaceboPPlacebo

USA
4ABC123DMABC1230100401004



2006-01-072006-01-08

01JOHNSON, M1941-07-02

MASIANNOT HISPANIC OR LATINO



SCREEN FAILURE
USA
5ABC123DMABC12302001020012006-02-022006-03-312006-02-022006-03-312006-01-152006-04-12

02GONZALEZ, E1950-06-2355YEARSFAMERICAN INDIAN OR ALASKA NATIVENOT HISPANIC OR LATINOPPlaceboPPlacebo

USA
6ABC123DMABC12302002020022006-02-032006-04-052006-02-032006-04-052006-01-102006-04-25

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

USA
7ABC123DMABC1230200302003



2006-02-072006-02-08

03GONZALEZ, 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 & 4:Shows USUBJID ABC12302003 specified "AMERICAN INDIAN OR ALASKA NATIVE" and "WHITE " as the race.

Row Captions Debug Message

Please construct row caption labels as instructed in <ac:link><ri:page ri:content-title="Constructing labels for row captions" ri:space-key="TTD"/></ac:link>.

$titleHtml

suppdm.xpt

RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIGQEVAL
1ABC123DMABC12301004

CRACE9Collected Race 9JAPANESECRF
2ABC123DMABC12301003

CRACE12Collected Race 12AFRICAN AMERICANCRF
3ABC123DMABC12302003

RACE5

Race 5

WHITECRF
4ABC123DMABC12302003

RACE1

Race 1

AMERICAN INDIAN OR ALASKA NATIVECRF

Dataset Debug Message

Please remove all formatting (see How to Clear Formatting).

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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