This is an example CRF used to collect some basic subject characteristics data.
| Xformpusher |
|---|
| CDASH Variable | Order | Question Text | Prompt | CRF Completion Instructions | Type | SDTMIG Target Variable | SDTM Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value | Query Display | List Style | Hidden | | SCPERF | 1 | Were subject characteristics collected? | Subject Characteristics Collected | Indicate if subject characteristics information was collected. If Yes, record the appropriate details. | Text | SCSTAT | If SCPERF = "Y", NOT SUBMITTED. If SCPERF = "N", SCSTAT where SCTESTCD = "SCALL". | (NY) | Yes; No |
|
|
|
| | EDLEVEL_SCORRES | 2 | What is the subject's education level? | Education Level | Indicate the subject's education level. | Text | SCORRES;SCTEST;SCTESTCD | 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 |
| prompt | radio |
| | JOBCLAS_SCORRES | 3 | What is the subject’s employment status? | Employment Status | Indicate the subject's employment status. | Text | SCORRES;SCTEST;SCTESTCD | SCORRES WHERE SCTESTCD = "JOBCLAS" | (EMPSTAT) | Full-time; Part-time; Not employed |
| prompt | radio |
| | INCOME_SCORRES | 4 | What is the subject's income? | Income | Indicate the subject's income . | Text | SCORRES;SCTEST;SCTESTCD | SCORRES WHERE SCTESTCD = "INCOME" |
| <100% poverty guideline.;100-200% poverty guidelines; >200% poverty guidelines; |
|
|
|
| | MARISTAT_SCORRES | 5 | What is the subject's marital status? | Marital Status | Indicate the subject's marital status. | Text | SCORRES;SCTEST;SCTESTCD | SCORRES WHERE SCTESTCD = "MARISTAT" | (MARISTAT) | Never Married; Married; Legally Divorced; Divorced; Widowed |
| prompt | radio |
| | NATORIG_SCORRES | 6 | What is the subject's national origin status? | National Origin | Indicate the subject's national origin | Text | SCORRES;SCTEST;SCTESTCD | SCORRES WHERE SCTESTCD = "NATORIG" |
|
|
|
|
|
| | JOBCLAS_SCORRES | 7 | What is the subject’s military status ? | Military Status | Indicate the subject's military status. | Text | SCORRES;SCTEST;SCTESTCD | SCORRES WHERE SCTESTCD = "MILTSTAT" | (xxxxx) | NO MILITARY SEVICE; ACTIVE SERVICE; VETERAN; |
| prompt | radio |
| | SECHNDTB | 8 | Was the subject exposed to second hand smoke ? | Second Hand Smoke Exposure | Indicate the subject's exposure to second hand smoke | Text | SCORRES;SCTEST;SCTESTCD | SCORRES WHERE SCTESTCD = "SECHNDTB" |
| No Exposure to Second Hand smoke; Exposure at Home only; Exposure at work only; Exposure at Work and Home; |
|
| radio |
|
|
This is an example of the SDTM dataset based on the data collected on the above CRF.
| Dataset wrap |
|---|
|
| Dataset2 |
|---|
| 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 | SECHNDTB | Second Hand Smoke Exposure | EXPOSURE AT WORK AND HOME | EXPOSURE AT WORK AND HOME |
| 1999-06-19 |
|
|
|
|
| INCOME | Income | <100% POVERTY GUIDELINES | <100% POVERTY GUIDELINES |
| 1999-06-19 | | 7 | ABC | SC | ABC-001-002 | 1 | SCALL | SUBJECT CHARACTERISTICS |
|
| NOT DONE | 2000-08-19 | |
|