| Metadataspec |
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| CDASH Variable Name | | Question Text | Prompt | CRF Completion Instructions | CDASH Variable Name | SDTMIG Target Variable | SDTM Target Mapping | Controlled Terminology Code List Name | Permissible Values | Pre-Populated Value |
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| 1 |
LBCAT | What was the name of the lab panel? | Lab Panel Name | Record the lab test category, if not pre-printed on the CRF. | LBCAT | 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. | LBPERF | 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). | LBDAT | LBDTC |
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| | 4 |
LBNAM | | What was the name of the laboratory used? | Laboratory Name | Record the laboratory name. | LBNAM | 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 | LBTEST; LBTESTCD | LBTEST and LBTESTCD | (LBTEST) | WBC; RBC, cells,Protein Urinalysis; Cholesterol, Albumin, Creatinine |
LBORRES
| | 6 | What was the result of the lab test? | Result | Record laboratory test result. | LBORRES |
LBORRESU| LBORRES |
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| | 7 | 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 | LBORRESU |
| (UNIT) | g/L; mg/dL; mg/L; U/mL; ug/L; sec; RATIO |
LBORNRLO
| | 8 | 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 | LBORNRLO |
LBORNRHI
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| | 9 | 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 |
LBNRIND| LBORNRHI |
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| | 10 | 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 | LBNRIND |
| (NRIND) | High; Normal; Low |
LBCLSIG
| | 11 | Was this result clinically significant? | Clinically Significant | Record whether lab results were clinically significant. | LBCLSIG | LBCLSIG |
| (NY) | Yes; No |
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