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.
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| title | CDASH CM SC Metadata Specifications |
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| Metadataspec |
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| CDASH Variable Name | CRF | Case Report Form Completion Instructions | Type |
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SDTMIG Target SDTM Target Mapping | Controlled Terminology Code List | Tabulation Target | Mapping Instructions | Controlled Terminology CodeList Name | Permissible Values | Pre-Populated Value |
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| 1 |
What is the category of the medication the subject used to attempt to reduce nicotine dependency? | Medication Category | Record the type of medicaiton the subject used to reduce nicotine dependency. | | Were subject characteristics collected? | Subject Characteristics Collected | Indicate if subject characteristics information was collected |
Indicate if the subject experienced any medical conditions or events include | record the appropriate details |
where indicated on the CRF.CMCAT | | . | Text | SCPERF | SCSTAT | If SCPERF = "Y", NOT SUBMITTED. If SCPERF = "N", SCSTAT where SCTESTCD = "SCALL". | (NY) | Yes; No |
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| Metadataspec |
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| 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 |
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NICOTINE REPLACEMENT THERAPY; DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS; subcategory for the medication| subject's education level? |
Medication SubcategoryRecord the medication subcategory, if not pre-printed on the CRF. | | 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 |
CMSCAT | LAST ATTEMPTED USE WITH THIS MEDICATION | | 3 | What |
was the name of the medication the subject used to reduce nicotine dependency? Medication | Record only one medication per line. Provide the full trade or proprietary name of the medication; otherwise, record the generic name. | Applicant-Defined CRF Completion Instructions | CMTRT | | 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" |
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| | 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 |
4 | What was the duration of the medication used to reduce nicotine dependency for the last attempt? | Collected Duration | Provide the duration of the medication used. | Record all relevant medical conditions or events, as defined in the protocol. Record only one medical condition or event per line. Ensure that the medical conditions or events listed on the Medical History page do not meet any of the exclusion criteria. | CMDUR | 5 | What was the duration unit of the medication used to reduce nicotine dependency for the last attempt? | Collected Duration Unit | Select the appropriate duration unit of the medication used. | Record the start date of the medical event or condition using this format (DD-MON-YYYY). | CMDUR | DAYS; MONTHS; YEARS |
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