CDASH Variable | Order | Question Text | Prompt | CRF Completion Instructions | Type | SDTMIG Target Variable | SDTMIG Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value | Query Display | List Style | Hidden |
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LBCAT | 1 | What was the name of the lab panel? | Lab Panel Name | Record the lab test category, if not pre-printed on the CRF. | Text | LBCAT |
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| HEMATOLOGY; CLINICAL CHEMISTRY URINALYSIS | Prompt |
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LBPERF | 3 | Was the lab performed? | Lab Performed | Indicate whether or not lab specimen was collected or measurement performed. | Text | LBSTAT | LBSTAT = "NOT DONE" where LBPERF = "N" and LBSTAT = null where LBPERF = "Y" | (NY) | Yes; No |
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LBDAT | 4 | What was the date of the lab specimen collection? | Specimen Collection Date | Record the date of specimen collection using this format (DD-MON-YYYY). | Date | LBDTC |
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LBNAM | 7 | What was the name of the laboratory used? | Laboratory Name | Record the laboratory name. | Text | LBNAM |
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LBTEST | 8 | 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. | Text | LBTEST; LBTESTCD | LBTEST and LBTESTCD | (LBTEST) | WBC; RBC, cells,Protein Urinalysis; Cholesterol, Albumin, Creatinine |
| Prompt | Radio |
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LBORRES | 10 | What was the result of the lab test? | Result | Record laboratory test result. | Text | LBORRES |
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LBORRESU | 11 | 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. | Text | LBORRESU |
| (UNIT) | g/L; mg/dL; mg/L; U/mL; ug/L; sec; RATIO |
| Prompt | Radio |
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LBORNRLO | 12 | 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. | Text | LBORNRLO |
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LBORNRHI | 13 | 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. | Text | LBORNRHI |
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LBNRIND | 14 | 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). | Text | LBNRIND |
| (NRIND) | High; Normal; Low |
| Prompt | Radio |
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LBCLSIG | 15 | Was this result clinically significant? | Clinically Significant | Record whether lab results were clinically significant. | Text | SUPPLB.QVAL | SUPPLB.QVAL where SUPPLB.QNAM = "LBCLSIG" and SUPPLB.QLABEL = "Clinically Significant" | (NY) | Yes; No |
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