| Order | CDASH Variable Name | Question Text | Prompt | CRF Completion Instructions | SDTMIG Target Variable | SDTM Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value |
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| 1 | LBCAT | What |
is category 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. | Indicate if the subject experienced any medical conditions or events. If Yes, include the appropriate details where indicated on the CRF. | CMCAT | | the lab panel? | Lab Panel Name | Record the lab test category, if not pre-printed on the CRF. | LBCAT |
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| HEMATOLOGY; CLINICAL CHEMISTRY; URINALYSIS |
| | 2 | LBPERF | Was the lab performed? | Lab Performed | Indicate whether or not lab specimen was collected or measurement performed. | LBSTAT | LBSTAT = "NOT DONE" where LBPERF = "N" and LBSTAT = null where LBPERF = "Y" | (NY) | Yes; No |
| | 3 | LBDAT | What was the date of the lab specimen collection? | Specimen Collection Date | Record the date of specimen collection using this format (DD-MON-YYYY). | LBDTC |
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| | 4 | LBNAM |
NICOTINE REPLACEMENT THERAPY; DRUG USED IN REDUCING NICOTINE DEPENDENCE OTHER THAN NRTS; 2 | What is the subcategory for the medication? | Medication Subcategory | Record the medication subcategory, if not pre-printed on the CRF. | CMSCAT | LAST ATTEMPTED USE WITH THIS MEDICATION | 3 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 | | laboratory used? | Laboratory Name | Record the laboratory name. | LBNAM |
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| | 5 | LBTEST | What is the lab test name? | Lab Test Name | Record the name of the lab measurement or finding, if not pre-printed on the CRF. If collected on the CRF, the sponsor may provide additional instructions to ensure the data is entered as intended. | LBTEST; LBTESTCD | LBTEST and LBTESTCD | (LBTEST) | WBC; RBC, cells,Protein Urinalysis; Cholesterol, Albumin, Creatinine |
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| LBORRES | What was the result of the lab test? | Result | Record laboratory test result. | LBORRES |
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| LBORRESU | What was the unit of the lab result? | Unit | Record or select the original unit in which these data were collected, if not pre-printed on CRF. | LBORRESU |
| (UNIT) | g/L; mg/dL; mg/L; U/mL; ug/L; sec; RATIO |
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| LBORNRLO | What was the lower limit of the reference range for this lab test? | Normal Range Lower Limit | Record the lower limit of the reference range of the lab test. | LBORNRLO |
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| LBORNRHI | What was the high limit of the reference range for this lab test? | Normal Range Upper Limit | Record the upper limit of the reference range of the lab test. | LBORNRHI |
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| LBNRIND | How do the reported values compare within the reference range? | Comparison to Reference Range | Record where the lab result fell with respect to the reference range (i.e., HIGH, NORMAL, LOW). | LBNRIND |
| (NRIND) | High; Normal; Low |
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| LBCLSIG | Was this result clinically significant? | Clinically Significant | Record whether lab results were clinically significant. | LBCLSIG |
| (NY) | Yes; No |
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 |