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This is an example of the SDTM LB dataset used to represent routine safety laboratory tests.
The LB dataset used the UNIT codelist for LBORRESU and LBORRESU. The LBLOINC variable contains a code from the LOINC database that identifies a specific laboratory test. The LOINC to LB Mapping Codetable (available at https://www.cdisc.org/standards/terminology/controlled-terminology) may be used to identify appropriate CDISC CT values for a test with a particular LOINC code.
LBNRIND was added to indicate where a result falls with respect to reference range defined by LBORNRLO and LBORNRHI. LBSTNRC was used to populated a normal range values that are character values for an ordinal scale (e.g., “NEGATIVE"). LBORNRLO, LBORNRHI, LBSTNRLO, and LBSTNRHI are null for these types of tests.
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| 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 | 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 | HEMATOLOGY; CLINICAL CHEMISTRY URINALYSIS | Prompt | 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 | Radio | 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 | Prompt | LBNAM | 7 | What was the name of the laboratory used? | Laboratory Name | Record the laboratory name. | Text | LBNAM | 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 | LBORRES | 10 | What was the result of the lab test? | Result | Record laboratory test result. | Text | LBORRES | Prompt | 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 | 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 | Prompt | 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 | Prompt | 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 | LBCLSIG | 15 | Was this result clinically significant? | Clinically Significant | Record whether lab results were clinically significant. | Text | LBCLSIG | (NY) | Yes; No | Radio | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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