Laboratory -Routine Clinical Labs Example 1

This is an example CRF used to collect routine safety labs that are often collected in tobacco studies.

	Lab Panel Name 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"	Yes No <NY codelist>
Record the date of specimen collection using this format (DD-MON-YYYY).	Specimen Collection Date LBDAT LBDTC	_ _ / _ _ _ / _ _ _ _
Record the laboratory name.	What was the name of the laboratory used? 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	WBC RBC, cells,Protein Urinalysis Cholesterol, Albumin, Creatinine <LBTEST codelist>
Record laboratory test result.	Result LBORRES	_________________
Record or select the original unit in which these data were collected, if not pre-printed on CRF.	Unit LBORRESU	g/L mg/dL mg/L U/mL ug/L sec RATIO <UNIT codelist>
Record the lower limit of the reference range of the lab test.	Normal Range Lower Limit LBORNRLO	_________________
Record the upper limit of the reference range of the lab test.	Normal Range Upper Limit LBORNRHI	_________________
Record where the lab result fell with respect to the reference range (i.e., HIGH, NORMAL, LOW).	Comparison to Reference Range LBNRIND	High Normal Low <NRIND codelist>
Record whether lab results were clinically significant.	Was this result clinically significant? LBCLSIG	Yes No <NY codelist>

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
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

This is an example of the SDTM LB dataset used to represent rotine safety laboratory tests.

The 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:	Show 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

lb.xpt

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

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Laboratory -Routine Clinical Labs Example 1