Demography (DM)

The Demography domain (DM) is a a special-purpose domain that includes a set of essential standard variables that describe each subject in a study. Companies use different methods to distinguish sites and investigators. CDISC assumes that SITEID will always be present, with INVID and INVNAM used as necessary. Every subject in a study must have a subject identifier (SUBJID). In some cases a subject may participate in more than 1 study. To identify a subject uniquely across all studies for all applications or submissions involving the product, a unique identifier (USUBJID) must be included in all datasets. 

The DM domain includes required variables that are often not directly collected on the Demography CRF. This data is populated using other sponsor sources of information.

Demographic information is collected about subjects in all clinical studies. The amount of demographic information collected will be determined by the analysis needs of the study and regulatory requirements, and may be affected by local restrictions related to data privacy. .

Example

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, 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.

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.

CDASH DM Metadata Specifications

Section 1 

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
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).	Date	BRTHDTC	BRTHDAT
2	What is the sex of the subject?	Sex	Record the appropriate sex (e.g., Female, Male).	Text	SEX	SEX		(SEX)	Female; Male; Unknown; Undifferentiated
3	Do you consider yourself Hispanic/Latino or not Hispanic/Latino?	Ethnicity	Record the participants self-report ethnicity,	Text	ETHNIC	ETHNIC		(ETHNIC)	Hispanic or Latino; Not Hispanic or Latino; Not Reported; Unknown
4	Which of the following racial designations best describes you? (More than 1 choice is acceptable.)	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 = RACE(n)  and SUPPDM.QLABEL = Race (n)	(RACE)	AMERICAN INDIAN OR ALASKA NATIVE;ASIAN;BLACK OR AFRICAN AMERICAN;NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER; WHITE;NOT REPORTED;UNKNOWN;OTHER

Section 2:  If the study participant answered: ASIAN or "BLACK OR AFRICAN AMERICAN.

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
5	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;
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;

This is an example SDTM dataset. This 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. When multiple races were self reported, the applicant recorded "MULTIPLE" as the Race and used Supplemental Qualifiers to record the self-reported race. 

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Row	STUDYID	DOMAIN	USUBJID	SUBJID	RFSTDTC	RFENDTC	RFXSTDTC	RFXENDTC	RFICDTC	RFPENDTC	DTHDTC	DTHFL	SITEID	INVNAM	BRTHDTC	SEX	RACE	ETHNIC	ARMCD	ARM	ACTARMCD	ACTARM	ARMNRS	ACTARMUD	COUNTRY
1	ABC123	DM	ABC123-0001	0001	2006-10-11	2007-01-10	2006-10-11	2007-01-10	2006-10-03	2007-02-01			01	JOHNSON, M	1948-12-13	M	WHITE	NOT HISPANIC OR LATINO	A	Product A	A	Product A			USA
2	ABC123	DM	ABC123-0002	0002	2006-01-15	2006-02-28	2006-01-15	2006-02-28	2006-01-04	2006-03-26			01	JOHNSON, M	1955-03-22	M	WHITE	NOT HISPANIC OR LATINO	B	Product B	B	Product B			USA
3	ABC123	DM	ABC123-0003	0003	2006-01-16	2006-03-19	2006-01-16	2006-03-19	2006-01-02	2006-03-19			01	JOHNSON, M	1938-01-19	F	BLACK OR AFRICAN AMERICAN	NOT HISPANIC OR LATINO	B	Product B	B	Product B			USA
4	ABC123	DM	ABC123-0004	0004					2006-01-07	2006-01-08			01	JOHNSON, M	1941-07-02	M	ASIAN	NOT HISPANIC OR LATINO					SCREEN FAILURE		USA
5	ABC123	DM	ABC123-2001	2001	2006-02-02	2006-03-31	2006-02-02	2006-03-31	2006-01-15	2006-04-12			02	GONZALEZ, E	1950-06-23	F	AMERICAN INDIAN OR ALASKA NATIVE	NOT HISPANIC OR LATINO	B	Product B	B	Product B			USA
6	ABC123	DM	ABC123-2002	2002	2006-02-03	2006-04-05	2006-02-03	2006-04-05	2006-01-10	2006-04-25			02	GONZALEZ, E	1956-05-05	F	NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERS	NOT HISPANIC OR LATINO	A	Product A	A	Product A			USA
7	ABC123	DM	ABC123-2003	2003					2006-02-07	2006-02-08			03	GONZALEZ, E	1945-04-06	F	MULTIPLE	NOT HISPANIC OR LATINO					SCREEN FAILURE		USA

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Row 1:	Shows USUBJID ABC123-0004 selected "JAPANESE" as the specific ASIAN race collected.
Row 2:	Shows USUBJID ABC123-0003 selected "AFRICAN AMERICAN" as the specific BLACK OR AFRICAN AMERICAN race collected.
Rows 3-4:	Show USUBJID ABC123-2003 specified "AMERICAN INDIAN OR ALASKA NATIVE" and "WHITE " as the race.

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Row	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG	QEVAL
1	ABC123	DM	ABC123-0004			CRACE9	Collected Race 9	JAPANESE	CRF
2	ABC123	DM	ABC123-0003			CRACE12	Collected Race 12	AFRICAN AMERICAN	CRF
3	ABC123	DM	ABC123-2003			RACE5	Race 5	WHITE	CRF
4	ABC123	DM	ABC123-2003			RACE1	Race 1	AMERICAN INDIAN OR ALASKA NATIVE	CRF

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