This example illustrates the use of the LB domain variables.
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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 |
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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 |
| 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 |
| 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 |
| LBCLSIG | 15 | Was this result clinically significant? | Clinically Significant | Record whether lab results were clinically significant. | Text | LBCLSIG |
| (NY) | Yes; No |
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The SDTM LB dataset used the UNIT codelist for LBORRESU and LBORRESU. The LBLOINC variable contains a code from the Logical Observation Identifiers Names and Codes (LOINC) database that identifies a specific laboratory test. were included by the sponsor. 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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Rows 1 -4: | Show records for common tests to evaluate hematogoly. The sponsor used LBCAT (HEMATOLOGY) to group these tests. | Rows 2-3: | Show 2 records for alkaline phosphatase done at the same visit, a day apart. LBPTFL is set to "Y" for both rows because each result is based on a sample from a single point in time. | Rows 5,7: | Shows records for common test under the grouping CLINICAL CHEMSITRY. | Row 6: | Shows a value collected in 1 unit, but converted to selected standard unit. | Row 9: | Shows use of LBSTNRC for Cannabinoids that is not reported as a continuous numeric result. The result was evaluated by the investigator and determined to be clinically significant |
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ROW | STUDYID | DOMAIN | USUBJID | LBSEQ | LBTESTCD | LBTEST | LBCAT | LBORRES | LBORRESU | LBORNRLO | LBORNRHI | LBSTRESC | LBSTRESN | LBSTRESU | LBORNRLOLBSTNRC | LBORNRHILBNRIND | LBSTNRC | LBRINDLBLOINC | LBSPEC | LBCLSIG | VISITNUM | LBDTC |
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1 | TBLB001 | LB | 001-001 | 1 | WBC | Leukocytes | HEMATOLOGY | 11.0 | 10^9/L | 4.5 | 11.0 | 11.0 | 11.0 | 10^9/L | 4.5 |
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| 11.026464-8 | BLOOD |
| 1 | 2020-12-01 | 2 | TBLB001 | LB | 001-001 | 2 | RBC | RBC | HEMATOLOGY | 5.4 | 10^12/L | 4.7 | 6.1 | 5.4 | 5.4 | 10^12/L |
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| 33051-4.7 | 6.1 | BLOOD |
| 1 | 2020-12-01 | 3 | TBLB001 | LB | 001-001 | 3 | PLAT | Platelets | HEMATOLOGY | 158 | 10^9/L | 150 | 400 | 158 | 158 | 10^9/L |
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| 15049497-1 | 400 | BLOOD |
| 1 | 2020-12-01 | 4 | TBLB001 | LB | 001-001 | 4 | HGB | Hemoglobin | HEMATOLOGY | 14.5 | g/dL | 14 | 18 | 14.5 | 14.5 | g/dL |
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| 14718-7 | 18 | BLOOD |
| 1 | 2020-12-01 | 5 | TBLB001 | LB | 001-001 | 5 | CHOL | Cholesterol | CLINICAL CHEMISTRY | 229 | mg/dL | 200 |
| 229 | 229 | mg/dL |
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| 2002093-3 | BLOOD |
| 1 | 2020-12-01 | 6 | TBLB001 | LB | 001-001 | 6 | ALB | Albumin | CLINICAL CHEMISTRY | 440.0 | g/dLL | 34 | 54 | 4.0 | 4.0 | g/dL | 3.4 |
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| 5.42862-1 | BLOOD |
| 1 | 2020-12-01 | 7 | TBLB001 | LB | 001-001 | 7 | CREAT | Creatinine | CLINICAL CHEMISTRY | 0.8 | mg/dL | 0.7 | 1.3 | 0.8 | 0.8 | mg/dl |
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| 2160-0.7 | 1.3 | BLOOD |
| 1 | 2020-12-01 | 8 | TBLB001 | LB | 001-001 | 8 | SPGRAV | Specific Gravity | URINALYSIS | 1.002 |
| 1.005 | 1.030 |
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| 2965-2 | URINE |
| 1 | 2020-12-01 | 9 | TBLB001 | LB | 001-001 | 9 | CANNAB | Cannabinoids | DRUG TOXICITY | POSITIVE |
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| POSITIVE |
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| POSITIVE | ABNORMAL | 18282-4 | URINE | Y | 1 | 2020-12-01 |
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