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Subject Characteristics (SC) is a Findings domain is and is an extension of 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.


OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
1Were subject characteristics collected?Subject Characteristics CollectedIndicate if subject characteristics information was collected. If Yes, record the appropriate details.TextSCPERFSCSTATIf SCPERF = "Y", NOT SUBMITTED. If SCPERF = "N", SCSTAT where SCTESTCD = "SCALL".(NY)Yes; No
OrderQuestion TextPromptCase Report Form Completion InstructionsTypeCollection VariableTabulation Target  Mapping Instructions  Controlled Terminology CodeList NamePermissible ValuesPre-Populated Value
2What is the subject's education level?Education LevelIndicate the subject's education level.TextEDLEVEL_SCORRESSCORRES;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 EducationLAST ATTEMPTED USE WITH THIS MEDICATION
3What is the subject’s employment status?Employment StatusIndicate the subject's employment status.TextJOBCLAS_SCORRESSCORRESSCORRES WHERE SCTESTCD = "JOBCLAS"(EMPSTAT)Full-time; Part-time; Not employed
4What is the subject's income?Income Indicate the subject's  income.TextINCOME_SCORRESSCORRESSCORRES WHERE SCTESTCD = "INCOME"

<100% poverty guideline.;100-200% poverty guidelines; >200% poverty guidelines;


5What is the subject's marital status?Marital StatusIndicate the subject's marital status.TextMARISTAT_SCORRESSCORRESSCORRES WHERE SCTESTCD = "MARISTAT"(MARISTAT)Never Married; Married; Legally Separated; Divorced; Widowed
6NATORIG_SCORRESWhat is the subject's national origin status?National OriginIndicate the subject's national origin NATORIG_SCORRESSCORRESSCORRES WHERE SCTESTCD = "NATORIG"


7MILTSTAT_SCORRESWhat is the subject’s military status?Military StatusIndicate the subject's military status.MILTSTAT_SCORRESSCORRESSCORRES WHERE SCTESTCD = "MILTSTAT"

NO MILITARY SEVICE;

ACTIVE SERVICE;

VETERAN;


8SHSMEXST_SCORRESWas the subject exposed to second hand smoke?Second Hand Smoke Exposure Status Indicate the subject's exposure to second hand smokeSHSMEXST_SCORRESSCORRESSCORRES WHERE SCTESTCD = "SHSMEXST"

No Exposure to Second Hand smoke; 

Exposure at Home only; 

Exposure at work only; 

Exposure at Work and Home; 


9AGESTSMK__SCORRESWhat was the age of the subject when they started smoking?  Age Started SmokingRecord the Age Category when the subject started smokingAGESTSMK__SCORRESSCORRESSCORRES WHERE SCTESTCD = "AGESTSMK"
16-24 years; 25-34 years; 45–64 years; 65 years and older
10TBCESSCO__SCORRESDid the subject have any tobacco cessation counseling?Tobacco Cessation Counseling Indicate whether the subject had previous tobacco cessation counseling.TBCESSCO__SCORRESSCORRESSCORRES WHERE SCTESTCD = "TBCESSCO"(NY)Yes; No
11LDURABS__SCORRESWhat is the longest duration of previous abstinence from tobacco use? Longest Duration of  AbstinenceRecord the longest duration of tobacco abstinenceLDURABS__SCORRESSCORRESSCORRES 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

sc.xpt

RowSTUDYIDDOMAINUSUBJIDSCSEQSCTESTCDSCTESTSCORRESSCSTRESCSCSTATSCDTC
1ABCSCABC-001-0011NATORIGNational OriginUNITED STATESUSA
1999-06-19
2ABCSCABC-001-0012MARISTATMarital StatusDIVORCEDDIVORCED
1999-06-19
3ABCSCABC-001-0013EDLEVELEducational LevelCOLLEGE OR BACCALAURETE DEGREE COMPLETECOLLEGE OR BACCALAURETE DEGREE COMPLETE
1999-06-19
4ABCSCABC-001-0014MILTSTATMilitary StatusVETERANVETERAN
1999-06-19
5ABCSCABC-001-0015JOBCLASEmployment StatusNOT EMPLOYEDNOT EMPLOYED
1999-06-19
6ABCSCABC-001-0016SHSMEXSTSecond Hand Smoke Exposure StatusEXPOSURE AT WORK AND HOMEEXPOSURE AT WORK AND HOME
1999-06-19
7ABCSCABC-001-0017INCOMEIncome<100% POVERTY GUIDELINES<100% POVERTY GUIDELINES
1999-06-19
8ABCSCABC-001-0018AGESTSMKAge Started Smoking16-24 years16-24 years
1999-06-19
9ABCSCABC-001-0019TBCESSCOTobacco Cessation CounselingNN
1999-06-19
10ABCSCABC-001-00110LDURABSLongest Duration of Abstinence1–6 months1–6 months
1999-06-19
11ABCSCABC-001-0021SCALLSubject Characteristics

NOT DONE2000-08-19
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