Laboratory -Routine Clinical Labs Example 1

	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

lb.xpt

ROW	STUDYID	DOMAIN	USUBJID	LBSEQ	LBTESTCD	LBTEST	LBCAT	LBORRES	LBORRESU	LBSTRESC	LBSTRESN	LBSTRESU	LBORNRLO	LBORNRHI	LBSTNRC	LBRIND	LBSPEC	LBCLSIG	VISITNUM	LBDTC
1	TBLB001	LB	001-001	1	WBC	Leukocytes	HEMATOLOGY	11.0	10^9/L	11.0	11.0	10^9/L	4.5	11.0			BLOOD		1	2020-12-01
2	TBLB001	LB	001-001	2	RBC	RBC	HEMATOLOGY	5.4	10^12/L	5.4	5.4	10^12/L	4.7	6.1			BLOOD		1	2020-12-01
3	TBLB001	LB	001-001	3	PLAT	Platelets	HEMATOLOGY	158	10^9/L	158	158	10^9/L	150	400			BLOOD		1	2020-12-01
4	TBLB001	LB	001-001	4	HGB	Hemoglobin	HEMATOLOGY	14.5	g/dL	14.5	14.5	g/dL	14	18			BLOOD		1	2020-12-01
5	TBLB001	LB	001-001	5	CHOL	Cholesterol	CLINICAL CHEMISTRY	229	mg/dL	229	229	mg/dL	200				BLOOD		1	2020-12-01
6	TBLB001	LB	001-001	6	ALB	Albumin	CLINICAL CHEMISTRY	4.0	g/dL	4.0	4.0	g/dL	3.4	5.4			BLOOD		1	2020-12-01
7	TBLB001	LB	001-001	7	CREAT	Creatinine	CLINICAL CHEMISTRY	0.8	mg/dL	0.8	0.8	mg/dl	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			URINE		1	2020-12-01
9	TBLB001	LB	001-001	9	CANNAB	Cannabinoids	DRUG TOXICITY	POSITIVE		POSITIVE					POSITIVE	ABNORMAL	URINE	Y	1	2020-12-01

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Laboratory -Routine Clinical Labs Example 1