Subject Characteristics

The Subject Characteristics (SC) domain is based on the Findings general observation class and is an extension of the demographics data, including socioeconomic or other broad characteristics. Subject characteristics may be collected periodically over time. Some examples of subject characteristics include education level, marital status, and national origin.

Associations between some subject characteristic tests and response codelists are described in the SC Codetable, available at https://www.cdisc.org/standards/terminology/controlled-terminology.

Example

This is an example CRF used to collect some basic subject characteristics data. There are 2 sections in this example. The questions in the first section focus on whether subject characteristics were collected and the questions in the second section are each subject characteristic collected. For an eCRF, if "No" is selected as the answer to the question in the first section, the second section would not be displayed.

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	Were subject characteristics collected?	Subject Characteristics Collected	Indicate if subject characteristics information was collected. If Yes, record the appropriate details.	Text	SCPERF	SCSTAT	If SCPERF = "Y", NOT SUBMITTED. If SCPERF = "N", SCSTAT where SCTESTCD = "SCALL".	(NY)	Yes; No

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
2	What is the subject's education level?	Education Level	Indicate the subject's education level.	Text	EDLEVEL_SCORRES	SCORRES;	SCORRES WHERE SCTESTCD = "EDLEVEL"		Did not complete Secondary School or Less than High School; Some Secondary School or High School Education; High School or Secondary School Degree Complete; Associate’s or Technical Degree Complete; College or Baccalaureate Degree Complete; Doctoral or Postgraduate Education	LAST ATTEMPTED USE WITH THIS MEDICATION
3	What is the subject’s employment status?	Employment Status	Indicate the subject's employment status.	Text	JOBCLAS_SCORRES	SCORRES	SCORRES WHERE SCTESTCD = "JOBCLAS"	(EMPSTAT)	Full-time; Part-time; Not employed
4	What is the subject's income?	Income	Indicate the subject's income.	Text	INCOME_SCORRES	SCORRES	SCORRES WHERE SCTESTCD = "INCOME"		<100% poverty guideline.;100-200% poverty guidelines; >200% poverty guidelines;
5	What is the subject's marital status?	Marital Status	Indicate the subject's marital status.	Text	MARISTAT_SCORRES	SCORRES	SCORRES WHERE SCTESTCD = "MARISTAT"	(MARISTAT)	Never Married; Married; Legally Separated; Divorced; Widowed
6	NATORIG_SCORRES	What is the subject's national origin status?	National Origin	Indicate the subject's national origin	NATORIG_SCORRES	SCORRES	SCORRES WHERE SCTESTCD = "NATORIG"
7	MILTSTAT_SCORRES	What is the subject’s military status?	Military Status	Indicate the subject's military status.	MILTSTAT_SCORRES	SCORRES	SCORRES WHERE SCTESTCD = "MILTSTAT"		NO MILITARY SEVICE; ACTIVE SERVICE; VETERAN;
8	SHSMEXST_SCORRES	Was the subject exposed to second hand smoke?	Second Hand Smoke Exposure Status	Indicate the subject's exposure to second hand smoke	SHSMEXST_SCORRES	SCORRES	SCORRES WHERE SCTESTCD = "SHSMEXST"		No Exposure to Second Hand smoke; Exposure at Home only; Exposure at work only; Exposure at Work and Home;
9	AGESTSMK__SCORRES	What was the age of the subject when they started smoking?	Age Started Smoking	Record the Age Category when the subject started smoking	AGESTSMK__SCORRES	SCORRES	SCORRES WHERE SCTESTCD = "AGESTSMK"		16-24 years; 25-34 years; 45–64 years; 65 years and older
10	TBCESSCO__SCORRES	Did the subject have any tobacco cessation counseling?	Tobacco Cessation Counseling	Indicate whether the subject had previous tobacco cessation counseling.	TBCESSCO__SCORRES	SCORRES	SCORRES WHERE SCTESTCD = "TBCESSCO"	(NY)	Yes; No
11	LDURABS__SCORRES	What is the longest duration of previous abstinence from tobacco use?	Longest Duration of Abstinence	Record the longest duration of tobacco abstinence	LDURABS__SCORRES	SCORRES	SCORRES WHERE SCTESTCD = "LDURABS"		≤7 days; 8–28 days;1–6 months; >6 months

This is an example of the SDTM dataset based on the data collected on the above CRF.

sc.xpt

Row	STUDYID	DOMAIN	USUBJID	SCSEQ	SCTESTCD	SCTEST	SCORRES	SCSTRESC	SCSTAT	SCDTC
1	ABC	SC	ABC-001-001	1	NATORIG	National Origin	UNITED STATES	USA		1999-06-19
2	ABC	SC	ABC-001-001	2	MARISTAT	Marital Status	DIVORCED	DIVORCED		1999-06-19
3	ABC	SC	ABC-001-001	3	EDLEVEL	Educational Level	COLLEGE OR BACCALAURETE DEGREE COMPLETE	COLLEGE OR BACCALAURETE DEGREE COMPLETE		1999-06-19
4	ABC	SC	ABC-001-001	4	MILTSTAT	Military Status	VETERAN	VETERAN		1999-06-19
5	ABC	SC	ABC-001-001	5	JOBCLAS	Employment Status	NOT EMPLOYED	NOT EMPLOYED		1999-06-19
6	ABC	SC	ABC-001-001	6	SHSMEXST	Second Hand Smoke Exposure Status	EXPOSURE AT WORK AND HOME	EXPOSURE AT WORK AND HOME		1999-06-19
7	ABC	SC	ABC-001-001	7	INCOME	Income	<100% POVERTY GUIDELINES	<100% POVERTY GUIDELINES		1999-06-19
8	ABC	SC	ABC-001-001	8	AGESTSMK	Age Started Smoking	16-24 years	16-24 years		1999-06-19
9	ABC	SC	ABC-001-001	9	TBCESSCO	Tobacco Cessation Counseling	N	N		1999-06-19
10	ABC	SC	ABC-001-001	10	LDURABS	Longest Duration of Abstinence	1–6 months	1–6 months		1999-06-19
11	ABC	SC	ABC-001-002	1	SCALL	Subject Characteristics			NOT DONE	2000-08-19

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Subject Characteristics