CDASH RYZE Example.Demography

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.

Order	Question Text	Prompt	Case Report Form Completion Instructions	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name
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).	BRTHDTC	BRTHDAT
2	What is the sex of the subject?	Sex	Record the appropriate sex (e.g., Female, Male).	SEX	SEX	(SEX)	Male; Female; Unknown; Undifferentiated
3	Do you consider yourself Hispanic/Latino or not Hispanic/Latino?	Ethnicity	Record the participants self-report ethnicity,	ETHNIC	ETHNIC	(ETHNIC)	Hispanic or Latino; Not Hispanic or Latino; Not Reported
4	What is the ethnicity of the subject? (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.	SUPPDM.QVAL	SUPPDM.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
5	Which of the following racial designations best describes you? (More than 1 choice is acceptable.)	Race	Record the participant self-report race,	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 study participant answered: ASIAN

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

11

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

Race

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;

If the study participant answered: BLACK OR AFRICAN AMERICAN