Versions Compared

Key

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

This is an example demography CRF where the sponsor collected information about a subject's race and ethnicity. The sponsor collected the Race and Ethnicity values listed in the FDA guidance on collecting race and ethnicity. Additionally, this sponsor  collected more details for subject who reported ASIAN or BLACK OR AFRICAN AMERICAN for Race, and for subject who self-reported ethnicity as Hispanic/Latino.    

Warning

Sponsors may append a suffix to denote multiple collected races and ethnicities (e.g. RACE1, RACE2, CRACE1, CRACE2, CETHNIC1, CETHNIC2). These are only examples and are not indicative of any prescribed values that must be followed. 

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. 

...

title Demography with detail Self-reported Race and Ethnicity collection 

    

...

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

...

SDTM

...

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

...

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

...

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.   This SDTM dataset includes information that is expected to be provided, but not usually collected directly on the Demography CRF. This includes  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. 

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

03GONZALEZ, 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.
Rows 3 & -4: Show USUBJID ABC12302003 ABC123-2003 specified "AMERICAN INDIAN OR ALASKA NATIVE" and "WHITE " as the race.  
Dataset2
RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIGQEVAL
1ABC123DM
ABC12301004
ABC123-0004

CRACE9Collected Race 9JAPANESECRF
2ABC123DM
ABC12301003
ABC123-0003

CRACE12Collected Race 12AFRICAN AMERICANCRF
3ABC123DM
ABC12302003
ABC123-2003

RACE5

Race 5

WHITECRF
4ABC123DM
ABC12302003
ABC123-2003

RACE1

Race 1

AMERICAN INDIAN OR ALASKA NATIVECRF