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title	CDASH LB Metadata Specifications

Metadataspec

Order	Question Text	Prompt	Case Report Form Completion Instructions	Type	Collection Variable	Tabulation Target	Mapping Instructions	Controlled Terminology CodeList Name	Permissible Values
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	LBCAT			HEMATOLOGY; CLINICAL CHEMISTRY; URINALYSIS
2	Was the lab performed?	Lab Performed	Indicate whether or not lab specimen was collected, or measurement performed.	Text	LBPERF	LBSTAT	LBSTAT = "NOT DONE" where LBPERF = "N" and LBSTAT = null where LBPERF = "Y"	(NY)	Yes; No
3	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	LBDAT	LBDTC
	What was the time of the lab specimen collection?	Specimen Collection Time	Record time of collection (as complete as possible).	Time	LBTIM

LBDAT

	LBDTC
4	What was the name of the laboratory used?	Laboratory Name	Record the laboratory name.	Text	LBNAM	LBNAM
5	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

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applicant may provide additional instructions to ensure the data is entered as intended.	Text	LBTEST	LBTEST; LBTESTCD	LBTEST and LBTESTCD	(LBTEST)	WBC; RBC, cells,Protein Urinalysis; Cholesterol, Albumin, Creatinine
6	What was the result of the lab test?	Result	Record laboratory test result.	Text	LBORRES	LBORRES
7	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	LBORRESU	(UNIT)	g/L; mg/dL; mg/L; U/mL; ug/L; sec; RATIO
8	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	LBORNRLO
9	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	LBORNRHI
10	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	LBNRIND	(NRIND)	High; Normal; Low
11	Was this result clinically significant?	Clinically Significant	Record whether lab results were clinically significant.	Text	LBCLSIG	LBCLSIG	(NY)	Yes; No

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