| 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 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 | LBSCAT | 2 | What was name of the lab sub-panel? | Lab Sub-Panel Name | Record the lab test subcategory, if not pre-printed on the CRF. | Text | LBSCAT | COAGULATION | 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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| Prompt | LBTIM | 5 | What was the time of the lab specimen collection? | Specimen Collection Time | Record time of collection (as complete as possible). | Time | LBDTC | Prompt | LBSPCCND | 6 | What was the condition of the specimen? | Specimen Condition | Record condition of specimen. | Text | LBSPCCND |
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| (SPECCOND) | FRESH; FROZEN; REFRIGERATED | Radio | 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) | Prothrombin Intl. Normalized Ratio; Activated Partial Thromboplastin Time; Prothrombin Time; Thrombin Time; Fibrinogen; D-Dimer; Factor V; Factor VIIIWBC; Protein Urinalysis; Cholesterol, Albumin, Creatinine |
| Prompt | Radio | LBMETHOD | 9 |
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| What was the method used for the lab test or examination? | Method of Test | Record the method of the test or examination. | Text | LBMETHOD | (METHOD) | CLAUSS METHOD; CLOT DETECTION; MANUAL CLOT DETECTION; MECHANICAL CLOT DETECTION; PHOTOMETRIC CLOT DETECTION | Radio | 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 |
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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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| Radio | LBTOXGR | 16 | What is the Toxicity Grade? | Toxicity Grade | Record the toxicity grade. | Text | LBTOXGR | 0; 1; 2; 3; 4 | Radio | LBTOX | 17 | What is the description of the toxicity? | Toxicity | Record the description of the toxicity. | Text | LBTOX |
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