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This example illustrates the use of the LB domain variables.  

LBCAT
Pre-populated
HEMATOLOGY; CLINICAL CHEMISTRY URINALYSIS
Indicate whether or not lab specimen was collected or measurement performed.Was the lab performed?
LBPERF LBSTAT = "NOT DONE" where LBPERF = "N" and LBSTAT = null where LBPERF = "Y"
<NY codelist>
Record the date of specimen collection using this format (DD-MON-YYYY).
LBDAT LBDTC
_ _ / _ _ _ / _ _ _ _
Record the laboratory name.
LBNAM
_________________
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.Lab Test Name
LBTEST LBTEST and LBTESTCD
<LBTEST codelist>
Record laboratory test result.
LBORRES
_________________
Record or select the original unit in which these data were collected, if not pre-printed on CRF.Unit
LBORRESU
<UNIT codelist>
Record the lower limit of the reference range of the lab test.
LBORNRLO
_________________
Record the upper limit of the reference range of the lab test.
LBORNRHI
_________________
Record where the lab result fell with respect to the reference range (i.e., HIGH, NORMAL, LOW).Comparison to Reference Range
LBNRIND
<NRIND codelist>
Record whether lab results were clinically significant.Was this result clinically significant?
LBCLSIG
<NY codelist>
CDASH   VariableOrderQuestion TextPromptCRF Completion InstructionsTypeSDTMIG Target VariableSDTMIG Target MappingControlled Terminology Code List NamePermissible ValuesPre-Populated ValueQuery DisplayList StyleHidden
LBCAT1What was the name of the lab  panel?Lab Panel NameRecord the lab test category, if not pre-printed on the CRF.TextLBCAT


HEMATOLOGY; CLINICAL CHEMISTRY URINALYSIS

Prompt

LBPERF3Was the lab performed?Lab PerformedIndicate whether or not lab specimen was collected or measurement performed.TextLBSTATLBSTAT = "NOT DONE" where LBPERF = "N" and LBSTAT = null where LBPERF = "Y"(NY)Yes; No

Radio
LBDAT4What was the date of the lab specimen collection?Specimen Collection DateRecord the date of specimen collection using this format (DD-MON-YYYY).DateLBDTC



Prompt

LBNAM7What was the name of the laboratory used?Laboratory NameRecord the laboratory name.TextLBNAM






LBTEST8What is the lab test name?Lab Test NameRecord 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.TextLBTEST;   LBTESTCDLBTEST and  LBTESTCD(LBTEST)WBC;  RBC,  cells,Protein  Urinalysis; Cholesterol, Albumin, Creatinine
PromptRadio
LBORRES10What was the result of the lab test?ResultRecord laboratory test result.TextLBORRES



Prompt

LBORRESU11What was the unit of the lab result?UnitRecord or select the original unit in which these data were collected, if not pre-printed on CRF.TextLBORRESU
(UNIT)g/L; mg/dL; mg/L; U/mL; ug/L; sec; RATIO
PromptRadio
LBORNRLO12What was the lower limit of the reference range for this lab test?Normal Range Lower LimitRecord the lower limit of the reference range of the lab test.TextLBORNRLO



Prompt

LBORNRHI13What was the high limit of the reference range for this lab test?Normal Range Upper LimitRecord the upper limit of the reference range of the lab test.TextLBORNRHI



Prompt

LBNRIND14How do the reported values compare within the reference range?Comparison to Reference RangeRecord where the lab result fell with respect to the reference range (i.e., HIGH, NORMAL, LOW).TextLBNRIND
(NRIND)High; Normal; Low
PromptRadio
LBCLSIG15Was this result clinically significant?Clinically SignificantRecord whether lab results were clinically significant.TextLBCLSIG
(NY)Yes; No

Radio

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.


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

Row Captions Debug Message

Please construct row caption labels as instructed in <ac:link><ri:page ri:content-title="Constructing labels for row captions" ri:space-key="TTD"/></ac:link>.

lb.xpt

lb.xpt

ROW

STUDYID

DOMAIN

USUBJID

LBSEQ

LBTESTCD

LBTEST

LBCAT

LBORRES

LBORRESU

LBORNRLOLBORNRHI

LBSTRESC

LBSTRESN

LBSTRESU

LBSTNRCLBNRINDLBLOINCLBSPECLBCLSIG

VISITNUM

LBDTC

1TBLB001LB001-0011WBCLeukocytesHEMATOLOGY11.010^9/L4.511.011.011.010^9/L

26464-8BLOOD
12020-12-01
2TBLB001LB001-0012RBCRBCHEMATOLOGY5.410^12/L4.76.15.45.410^12/L

33051-4BLOOD
12020-12-01
3TBLB001LB001-0013PLATPlateletsHEMATOLOGY15810^9/L15040015815810^9/L

49497-1BLOOD
12020-12-01
4TBLB001LB001-0014HGBHemoglobinHEMATOLOGY14.5g/dL141814.514.5g/dL

718-7BLOOD
12020-12-01
5TBLB001LB001-0015CHOLCholesterolCLINICAL CHEMISTRY229mg/dL200
229229mg/dL

2093-3BLOOD
12020-12-01
6TBLB001LB001-0016ALBAlbuminCLINICAL CHEMISTRY40.0g/L 34544.04.0g/dL

2862-1BLOOD
12020-12-01
7TBLB001LB001-0017CREATCreatinineCLINICAL CHEMISTRY0.8mg/dL0.71.30.80.8mg/dl

2160-0BLOOD
12020-12-01
8TBLB001LB001-0018SPGRAVSpecific GravityURINALYSIS1.002
1.0051.030




2965-2URINE
12020-12-01
9TBLB001LB001-0019CANNABCannabinoidsDRUG TOXICITYPOSITIVE


POSITIVE

POSITIVEABNORMAL18282-4URINEY12020-12-01

Dataset Debug Messages

  • There is a leading, trailing, or non-breaking space in the dataset.
  • Please remove all formatting (see How to Clear Formatting).

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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