Demography Example 1

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. Investigator and site identification: 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.

In this study, 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 race self reported. The sponsor also collected more details associated with selected Race categories These collected race were also reported as Supplemental Qualifiers

Example

Title : Study Participants Self-reported Race

Record the subject's year of birth (e.g., YYYY, a 4-digit year).	What is the subject's year of birth? BRTHDAT BRTHDTC	_________________
Record the appropriate sex (e.g., Female, Male).	What is the sex of the subject? SEX	Male Female Unknown Undifferentiated <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	Hispanic or Latino Not Hispanic or Latino Not Reported <ETHNIC codelist>
Select each value that applies to the subject	What is the ethnicity of the subject? CETHNIC(n) SUPPDM.QVAL where SUPPDM.QNAM = ETHNIC(n) and SUPPDM.QLABEL = Collected Ethnicity (n)	Add the long list <ETHNICC codelist>
Study participants should self-report race, with race being asked about after ethnicity. (More than 1 choice is acceptable.)	Which of the following racial designations best describes you? (Check all that apply RACE(n) RACE	American Indian or Alaska Native:Asian Black or African American Native Hawaiian or Other Pacific Islander White UNKNOWN: OTHER: <RACE codelist>

CDASH Variable

Order

Question Text

Prompt

CRF Completion Instructions

Type

SDTMIG Target Variable

SDTM Target Mapping

Controlled Terminology Code List Name

Permissible Values

Pre-specified Value

Query Display

List Style

Hidden

BRTHDAT

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).

Text

BRTHDTC

SEX

2

What is the sex of the subject?

Sex

Record the appropriate sex (e.g., Female, Male).

Text

SEX

(SEX)

Male; Female; Unknown; Undifferentiated

radio

ETHNIC

3

Do you consider yourself Hispanic/Latino or not Hispanic/Latino?

Ethnicity

Study participants should self-report ethnicity, with ethnicity being asked about before race.

Text

ETHNIC

(ETHNIC)

Hispanic or Latino; Not Hispanic or Latino; Not Reported

radio

CETHNIC(n)

4

What is the ethnicity of the subject?

Ethnicity

Select each value that applies to the subject

Text

SUPPDM.QVAL

SUPPDM.QVAL where SUPPDM.QNAM = ETHNIC(n) and SUPPDM.QLABEL = Collected Ethnicity (n)

(ETHNICC)

Add the long list

checkbox

RACE(n)

5

Which of the following racial designations best describes you? (Check all that apply

Race

Study participants should self-report race, with race being asked about after ethnicity. (More than 1 choice is acceptable.)

Text

RACE

(RACE)

American Indian or Alaska Native:
Asian;
Black or African American;
Native Hawaiian or Other Pacific Islander;
White; UNKNOWN:
OTHER:

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.	ASIAN AMERICAN ASIAN INDIAN BANGLADESHI CHINESE JAPANESE KOREAN <RACEC codelist>

CDASH Variable

Order

Question Text

Prompt

CRF Completion Instructions

Type

SDTMIG Target Variable

SDTM Target Mapping

Controlled Terminology Code List Name

Permissible Values

Pre-specified Value

Query Display

List Style

Hidden

CRACE05-CRACE10

11

Which of the following racial designations best describes you?

Race

Select each value that applies if the subject answered "ASIAN". Check all that apply.

Text

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.

(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.	AFRICAN AFRICAN AMERICAN AFRICAN CARIBBEAN BAHAMIAN BARBADIAN BLACK BLACK CENTRAL AMERICAN <RACEC codelist>

CDASH Variable

Order

Question Text

Prompt

CRF Completion Instructions

Type

SDTMIG Target Variable

SDTM Target Mapping

Controlled Terminology Code List Name

Permissible Values

Pre-specified Value

Query Display

List Style

Hidden

CRACE11-CRACE17

12

Which of the following racial designations best describes you?

Race

Select each value that applies if the subject answered "BLACK OR AFRICAN AMERICAN". Check all that apply.

Text

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.

(RACEC)

AFRICAN; AFRICAN AMERICAN; AFRICAN CARIBBEAN; BAHAMIAN; BARBADIAN; BLACK; BLACK CENTRAL AMERICAN;

checkbox

This is an example SDTM dataset.

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 race self reported. The sponsor also collected more details associated with selected Race categories These collected race were also reported as Supplemental Qualifiers

Note that this SDTM dataset includes information that is expected to be provided, but not usually collected directly on the Demography CRF. RFSTDTC, RFENDTC, RFXSTDTC, RFXENDTC, RFCSTDTC, RFCENDTC, RFICDTC

dm.xpt

Row	STUDYID	DOMAIN	USUBJID	SUBJID	RFSTDTC	RFENDTC	RFXSTDTC	RFXENDTC	RFICDTC	RFPENDTC	SITEID	INVNAM	BRTHDTC	AGE	AGEU	SEX	RACE	ETHNIC	ARMCD	ARM	ACTARMCD	ACTARM	ARMNRS	COUNTRY
1	ABC123	DM	ABC12301001	01001	2006-01-12	2006-03-10	2006-01-12	2006-03-10	2006-01-03	2006-04-01	01	JOHNSON, M	1948-12-13	57	YEARS	M	WHITE	HISPANIC OR LATINO	A	Drug A	A	Drug A		USA
2	ABC123	DM	ABC12301002	01002	2006-01-15	2006-02-28	2006-01-15	2006-02-28	2006-01-04	2006-03-26	01	JOHNSON, M	1955-03-22	50	YEARS	M	WHITE	NOT HISPANIC OR LATINO	P	Placebo	P	Placebo		USA
3	ABC123	DM	ABC12301003	01003	2006-01-16	2006-03-19	2006-01-16	2006-03-19	2006-01-02	2006-03-19	01	JOHNSON, M	1938-01-19	68	YEARS	F	BLACK OR AFRICAN AMERICAN	NOT HISPANIC OR LATINO	P	Placebo	P	Placebo		USA
4	ABC123	DM	ABC12301004	01004					2006-01-07	2006-01-08	01	JOHNSON, M	1941-07-02			M	ASIAN	NOT HISPANIC OR LATINO					SCREEN FAILURE	USA
5	ABC123	DM	ABC12302001	02001	2006-02-02	2006-03-31	2006-02-02	2006-03-31	2006-01-15	2006-04-12	02	GONZALEZ, E	1950-06-23	55	YEARS	F	AMERICAN INDIAN OR ALASKA NATIVE	NOT HISPANIC OR LATINO	P	Placebo	P	Placebo		USA
6	ABC123	DM	ABC12302002	02002	2006-02-03	2006-04-05	2006-02-03	2006-04-05	2006-01-10	2006-04-25	02	GONZALEZ, E	1956-05-05	49	YEARS	F	NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDERS	NOT HISPANIC OR LATINO	A	Drug A	A	Drug A		USA
7	ABC123	DM	ABC12302003	02003					2006-02-07	2006-02-08	01	GONZALEZ, E	1945-04-06			F	MULTIPLE	NOT 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:	Shows USUBJID ABC12302003 specified " BLACK OR AFRICAN AMERICAN and "WHITE " as the race.

$titleHtml

suppdm.xpt

Row	STUDYID	RDOMAIN	USUBJID	QNAM	QLABEL	QVAL	QORIG
1	ABC123	DM	ABC12301004	CRACE3	Collected Race 3	JAPANESE	CRF
2	ABC123	DM	ABC12301003	CRACE5	Collected Race 5	AFRICAN AMERICAN	CRF
3	ABC123	DM	ABC12302003	CRACE8	Collected Race 8	BLACK	CRF
4	ABC123	DM	ABC12302003	RACE1	Race 1	WHITE	CRF
5	ABC123	DM	ABC12302003	RACE2	Race 2	BLACK OR AFRICAN AMERICAN	CRF

$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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Demography Example 1