SDTM Example.Demography

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 subjects who self-reported ethnicity as Hispanic/Latino.

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 subjects 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

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>
For a subject who self-reported ethnicity as Hispanic or Latino, 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)	CENTRAL AMERICAN CUBAN AMERICAN LATIN AMERICAN MEXICAN MEXICAN AMERICAN PUERTO RICAN SOUTH AMERICAN SPANISH <ETHNICC codelist>
Study participants should self-report race, with race being asked about after ethnicity.	Which of the following racial designations best describes you? (More than 1 choice is acceptable.) RACE(n) RACE	AMERICAN INDIAN OR ALASKA NATIVE ASIAN BLACK OR AFRICAN AMERICAN NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER WHITE NOT REPORTED UNKNOWN <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

For a subject who self-reported ethnicity as Hispanic or Latino, 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)

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

checkbox

RACE(n)

5

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

Race

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

Text

RACE

(RACE)

AMERICAN INDIAN OR ALASKA NATIVE;ASIAN;BLACK OR AFRICAN AMERICAN;NATIVE HAWAIIAN OR OTHER PACIFIC ISLANDER; WHITE;NOT REPORTED;UNKNOWN

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. This SDTM 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.

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	NOT HISPANIC OR LATINO	A	Product A	A	Product 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	B	Product B	B	Product B		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	B	Product B	B	Product B		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	B	Product B	B	Product B		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	Product A	A	Product A		USA
7	ABC123	DM	ABC12302003	02003					2006-02-07	2006-02-08	03	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 & 4:	Show USUBJID ABC12302003 specified "AMERICAN INDIAN OR ALASKA NATIVE" and "WHITE " as the race.

Row Captions Debug Message

Please construct row caption labels as instructed in <ac:link><ri:page ri:content-title="Constructing labels for row captions" ri:space-key="TTD"/></ac:link>.

$titleHtml

suppdm.xpt

Row	STUDYID	RDOMAIN	USUBJID	QNAM	QLABEL	QVAL	QORIG
1	ABC123	DM	ABC12301004	CRACE9	Collected Race 9	JAPANESE	CRF
2	ABC123	DM	ABC12301003	CRACE12	Collected Race 12	AFRICAN AMERICAN	CRF
3	ABC123	DM	ABC12302003	RACE5	Race 5	WHITE	CRF
4	ABC123	DM	ABC12302003	RACE1	Race 1	AMERICAN INDIAN OR ALASKA NATIVE	CRF

$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

Page tree

SDTM Example.Demography