This is an example demography CRF where the applicant collected information about a subject's race and ethnicity. The applicant collected the Race and Ethnicity values listed in the FDA guidance on collecting race and ethnicity. Additionally, this applicant collected more details for subjects who reported ASIAN or BLACK OR AFRICAN AMERICAN for Race. When multiple races were self reported, and for subjects who self-reported ethnicity as Hispanic/Latino. the applicant recorded "MULTIPLE" as the Race and used Supplemental Qualifiers to record the self-reported race. In order to save space, some of the example permissible values are only shown in the metadata specifications.
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Applicants 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 aCRF are only examples and are not indicative of any prescribed values that must be followed. |
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| title | CDASH DM Metadata Specifications |
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Section 1 | Metadataspec |
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CRF | Case Report Form Completion Instructions | Type |
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CDASH SDTMIG Target Variable | SDTMIG Target Mapping | Controlled | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Name | Permissible Values | Pre-Populated Value |
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| 1 | What is the subject's year of birth? | Birth Date | Record the subject's year of birth (e.g., YYYY, a 4-digit year). |
BRTHDAT| Date | BRTHDTC | BRTHDAT |
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| | 2 | What is the sex of the subject? | Sex | Record the appropriate sex (e.g., Female, Male). |
SEX| Text | SEX | SEX |
| (SEX) | Female; Male |
; Female| ; Unknown; Undifferentiated |
| | 3 | Do you consider yourself Hispanic/Latino or not Hispanic/Latino? | Ethnicity | Record the participants self-report ethnicity, |
ETHNIC| Text | ETHNIC | ETHNIC |
| (ETHNIC) | Hispanic or Latino; Not Hispanic or Latino; Not Reported; Unknown |
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What is the ethnicity subjectfollowing racial designations best describes you? (More than 1 choice is acceptable.) |
Ethnicity | For a subject who self-reported ethnicity as Hispanic or Latino, Select each value that applies to the subject. | CETHNIC(n) | SUPPDM.QVAL | | Race | Record the participant self-report race, | Text | RACE1-RACE6 | RACE SUPPDM.QVAL | RACE or RACE="MULTIPLE" and each Race is represented as a SUPPDM.QVAL where SUPPDM.QNAM = |
ETHNIC| RACE(n) and SUPPDM.QLABEL = |
Collected Ethnicity ETHNICCCENTRAL | AMERICAN INDIAN OR ALASKA NATIVE;ASIAN;BLACK OR AFRICAN AMERICAN;NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER; WHITE;NOT REPORTED;UNKNOWN;OTHER |
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Section 2: If the study participant answered: ASIAN or "BLACK OR AFRICAN AMERICAN. | Metadataspec |
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| Order | Question Text | Prompt | Case Report Form Completion Instructions | Type | Collection Variable | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Name | Permissible Values | Pre-Populated Value |
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; CUBAN AMERICAN; LATIN AMERICAN; MEXICAN; MEXICAN AMERICAN;PUERTO RICAN;SOUTH AMERICAN ; SPANISH |
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| 5 | Which of the following racial designations best describes you? (More than 1 choice is acceptable.) | Race |
Record the participant self-report race, | RACE(n) | RACE | RACE(n) | (RACE) | AMERICAN INDIAN OR ALASKA NATIVE;ASIAN;BLACK OR AFRICAN AMERICAN;NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER; WHITE;NOT REPORTED;UNKNOWN| If the subject answered "ASIAN" Select each value that applies. | Text | CRACE05-CRACE10 | SUPPDM.QVAL | For each value that applies, SUPPDM.QVAL where SUPPDM.QNAM ="CRACEn" and SUPPDM.QLABEL = "Collected Race n" where n is the choice value. |
| ASIAN AMERICAN; ASIAN INDIAN; BANGLADESHI; CHINESE; JAPANESE; KOREAN;
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| | 6 | Which of the following racial designations best describes you? (More than 1 choice is acceptable.) | Race | If the subject answered "BLACK OR AFRICAN AMERICAN".Select each value that applies. | Text | CRACE11-CRACE17 | SUPPDM.QVAL | For each value that applies, SUPPDM.QVAL where SUPPDM.QNAM ="CBACEn" and SUPPDM.QLABEL = "Collected Race n" where n is the choice value. |
| AFRICAN; AFRICAN AMERICAN; AFRICAN CARIBBEAN; BAHAMIAN; BARBADIAN; BLACK; BLACK CENTRAL AMERICAN;
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