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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.

Dataset wrap

Name	lb

Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-283

Rowcaps

Rows 1-4:	Show records for common tests to evaluate hematology. The applicant used LBCAT (HEMATOLOGY) to group these tests.
Rows 5, 7, 8:	Show records for common tests. LBCAT indicates the category assigned for these laboratory tests.
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

Dataset2

ROW	STUDYID	DOMAIN	USUBJID	LBSEQ	LBTESTCD	LBTEST	LBCAT	LBORRES	LBORRESU	LBORNRLO	LBORNRHI	LBSTRESC	LBSTRESN	LBSTRESU	LBSTNRC	LBSTNRLO	LBSTNRHI	LBNRIND	LBLOINC	LBSPEC	LBLOBXFL	LBCLSIG	VISITNUM	LBDTC
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	11.0		26464-8	BLOOD	Y		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		4.7	6.1		33051-4	BLOOD	Y		1	2020-12-01
3	TBLB001	LB	001-001	3	PLAT	Platelets	HEMATOLOGY	158	10^9/L	150	400	158	158	10^9/L		150	400		49497-1	BLOOD	Y		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		14	18		718-7	BLOOD	Y		1	2020-12-01
5	TBLB001	LB	001-001	5	CHOL	Cholesterol	CLINICAL CHEMISTRY	229	mg/dL	200		229	229	mg/dL		200			2093-3	BLOOD	Y		1	2020-12-01
6	TBLB001	LB	001-001	6	ALB	Albumin	CLINICAL CHEMISTRY	40.0	g/L	34	54	4.0	4.0	g/dL		3.4	5.4		2862-1	BLOOD	Y		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		0.7	1.3		2160-0	BLOOD	Y		1	2020-12-01
8	TBLB001	LB	001-001	8	SPGRAV	Specific Gravity	URINALYSIS	1.002		1.005	1.030					1.005	1.030		2965-2	URINE	Y		1	2020-12-01
9	TBLB001	LB	001-001	9	CANNAB	Cannabinoids	DRUG TOXICITY	POSITIVE				POSITIVE			POSITIVE			ABNORMAL	18282-4	URINE	Y	Y	1	2020-12-01

Xformpusher

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

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

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

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

(SPECCOND)

FRESH; FROZEN; REFRIGERATED

Radio

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)

Prothrombin Intl. Normalized Ratio; Activated Partial Thromboplastin Time; Prothrombin Time; Thrombin Time; Fibrinogen; D-Dimer; Factor V; Factor VIII

Prompt

Radio

LBMETHOD

9

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

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

SUPPLB.QVAL

SUPPLB.QVAL where SUPPLB.QNAM = "LBCLSIG" and SUPPLB.QLABEL = "Clinically Significant"

(NY)

Yes; No

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

Dataset wrap

Name	lb

CRF

Rowcaps

Rows 1, 9:

Rows 8, 16:

Rows 2-7, 10-15:

Dataset2

STUDYID

DOMAIN

USUBJID

LBSEQ

LBTESTCD

LBTEST

LBCAT

LBORRES

LBORRESU

LBSTRESC

LBSTRESN

LBSTRESU

LBSPEC

LBMETHOD

LBANMETH

VISITNUM

VISIT

VISITDY

LBDTC

LBENDTC

LBDY

LBENDY

LBCOLSRT

1

CHOL

Cholesterol

CLINICAL CHEMISTRY

2

ALB

Albumin

CLINICAL CHEMISTRY

3

WBC

HEMATOLOGY

4

URINALYSIS

5

Row

CREAT

Creatinine

CLINICAL CHEMISTRY

6

7

Nsvmeta

Domain	LB

Variable

Label

Type

Role

Codelist

Origin

LBCOLSRT

Collected Summary Result Type

text

Non-standard Record Qualifier

(COLSTYP)

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