Lab Example 1

	Lab Panel Name LBCAT Pre-populated	HEMATOLOGY
	Lab Sub-Panel Name LBSCAT Pre-populated	COAGULATION
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 time of collection (as complete as possible).	Specimen Collection Time LBTIM LBDTC	_ _ : _ _ : _ _
Record condition of specimen.	What was the condition of the specimen? LBSPCCND	FRESH FROZEN REFRIGERATED <SPECCOND codelist>
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	Prothrombin Intl. Normalized Ratio Activated Partial Thromboplastin Time Prothrombin Time Thrombin Time Fibrinogen D-Dimer Factor V Factor VIII <LBTEST codelist>
Record the method of the test or examination.	What was the method used for the lab test or examination? LBMETHOD	CLAUSS METHOD CLOT DETECTION MANUAL CLOT DETECTION MECHANICAL CLOT DETECTION PHOTOMETRIC CLOT DETECTION <METHOD 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 SUPPLB.QVAL where SUPPLB.QNAM = "LBCLSIG" and SUPPLB.QLABEL = "Clinically Significant"	Yes No <NY codelist>
Record the toxicity grade.	What is the Toxicity Grade? LBTOXGR	0 1 2 3 4
Record the description of the toxicity.	What is the description of the toxicity? LBTOX	_________________

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	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

C-Reactive Protein (CRP),LDL),Fibrinogen,(IL-6), total cholesterol,triglycerides ,urinary cotinine test

Rows 1, 9:	Show that glucose was measured for approximately 24 hours, and the mean glucose value was represented in LBORRES/LBSTRESC. The collected summary result is represented in the NSV LBCOLSRT. LBTEST is "Plasma Equivalent Glucose" as the results represent a concentration of glucose.
Rows 8, 16:	Show the GMI results calculated by the device based on glucose results collected during the 14-day period that ended on the day of each visit. The value of the LBANMETH variable indicates that the GMI results were calculated as a percentage based on mean glucose measurements reported in mg/dL.
Rows 2-7, 10-15:	Show other statistics that were calculated by the CGM device from the raw glucose levels collected during the specified interval. Again, LBCOLSRT is used to indicate which summary statistic was calculated for the glucose values collected in this interval. LBTEST is "Plasma Equivalent Glucose Distribution" as these are tests about the distribution of the glucose measurements.

lb.xpt

Row	STUDYID	DOMAIN	USUBJID	SPDEVID	LBSEQ	LBTESTCD	LBTEST	LBORRES	LBORRESU	LBSTRESC	LBSTRESN	LBSTRESU	LBSPEC	LBMETHOD	LBANMETH	VISITNUM	VISIT	VISITDY	LBDTC	LBENDTC	LBDY	LBENDY	LBCOLSRT
1	T005	LB	001	CGM-001	1	GLUCPE	Plasma Equivalent Glucose	113.7	mg/dL	113.7	113.7	mg/dL	INTERSTITIAL FLUID	CALCULATION	DEVICE ALGORITHM	2	WEEK 2	15	2016-09-28T08:00	2016-09-29T08:00	14	15	MEAN
2	T005	LB	001	CGM-001	2	GLUCPED	Plasma Equivalent Glucose Distribution	15		15	15		INTERSTITIAL FLUID	CALCULATION	DEVICE ALGORITHM	2	WEEK 2	15	2016-09-28T08:00	2016-09-29T08:00	14	15	STANDARD DEVIATION
3	T005	LB	001	CGM-001	3	GLUCPED	Plasma Equivalent Glucose Distribution	13.7		13.7	13.7		INTERSTITIAL FLUID	CALCULATION	DEVICE ALGORITHM	2	WEEK 2	15	2016-09-28T08:00	2016-09-29T08:00	14	15	COEFFICIENT OF VARIATION
4	T005	LB	001	CGM-001	4	GLUCPED	Plasma Equivalent Glucose Distribution	0	%	0	0	%	INTERSTITIAL FLUID	CALCULATION	DEVICE ALGORITHM	2	WEEK 2	15	2016-09-28T08:00	2016-09-29T08:00	14	15	PROPORTION LOW
5	T005	LB	001	CGM-001	5	GLUCPED	Plasma Equivalent Glucose Distribution	0	%	0	0	%	INTERSTITIAL FLUID	CALCULATION	DEVICE ALGORITHM	2	WEEK 2	15	2016-09-28T08:00	2016-09-29T08:00	14	15	PROPORTION HIGH
6	T005	LB	001	CGM-001	6	GLUCPED	Plasma Equivalent Glucose Distribution	100	%	100	100	%	INTERSTITIAL FLUID	CALCULATION	DEVICE ALGORITHM	2	WEEK 2	15	2016-09-28T08:00	2016-09-29T08:00	14	15	PROPORTION WITHIN TARGET RANGE
7	T005	LB	001	CGM-001	7	GLUCPED	Plasma Equivalent Glucose Distribution	0	min	0	0	min	INTERSTITIAL FLUID	CALCULATION	DEVICE ALGORITHM	2	WEEK 2	15	2016-09-28T08:00	2016-09-29T08:00	14	15	TIME IN CRITICAL LOW RANGE
8	T005	LB	001	CGM-001	8	GMI	Glucose Management Indicator	6.04	%	6.04	6.04	%	INTERSTITIAL FLUID	CALCULATION	GMI % FORMULA	2	WEEK 2	15	2016-09-15T08:00	2016-09-29T08:00	1	15
9	T005	LB	001	CGM-001	9	GLUCPE	Plasma Equivalent Glucose	110.7	mg/dL	110.7	110.7	mg/dL	INTERSTITIAL FLUID	CALCULATION	DEVICE ALGORITHM	10	WEEK 52	365	2017-09-13T08:02	2017-09-14T07:57	364	365	MEAN
10	T005	LB	001	CGM-001	10	GLUCPED	Plasma Equivalent Glucose Distribution	15		15	15		INTERSTITIAL FLUID	CALCULATION	DEVICE ALGORITHM	10	WEEK 52	365	2017-09-13T08:02	2017-09-14T07:57	364	365	STANDARD DEVIATION
11	T005	LB	001	CGM-001	11	GLUCPED	Plasma Equivalent Glucose Distribution	13.7		13.7	13.7		INTERSTITIAL FLUID	CALCULATION	DEVICE ALGORITHM	10	WEEK 52	365	2017-09-13T08:02	2017-09-14T07:57	364	365	COEFFICIENT OF VARIATION
12	T005	LB	001	CGM-001	12	GLUCPED	Plasma Equivalent Glucose Distribution	0	%	0	0	%	INTERSTITIAL FLUID	CALCULATION	DEVICE ALGORITHM	10	WEEK 52	365	2017-09-13T08:02	2017-09-14T07:57	364	365	PROPORTION LOW
13	T005	LB	001	CGM-001	13	GLUCPED	Plasma Equivalent Glucose Distribution	0	%	0	0	%	IINTERSTITIAL FLUID	CALCULATION	DEVICE ALGORITHM	10	WEEK 52	365	2017-09-13T08:02	2017-09-14T07:57	364	365	PROPORTION HIGH
14	T005	LB	001	CGM-001	14	GLUCPED	Plasma Equivalent Glucose Distribution	100	%	100	100	%	INTERSTITIAL FLUID	CALCULATION	DEVICE ALGORITHM	10	WEEK 52	365	2017-09-13T08:02	2017-09-14T07:57	364	365	PROPORTION WITHIN TARGET RANGE
15	T005	LB	001	CGM-001	15	GLUCPED	Plasma Equivalent Glucose Distribution	0	min	0	0	min	INTERSTITIAL FLUID	CALCULATION	DEVICE ALGORITHM	10	WEEK 52	365	2017-09-13T08:02	2017-09-14T07:57	364	365	TIME IN CRITICAL LOW RANGE
16	T005	LB	001	CGM-001	16	GMI	Glucose Management Indicator	5.93	%	5.93	5.93	%	INTERSTITIAL FLUID	CALCULATION	GMI % FORMULA	10	WEEK 52	365	2017-08-31T08:02	2017-09-14T07:57	351	365

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LB NSV Metadata

Variable	Label	Type	Role	Codelist	Origin
LBCOLSRT	Collected Summary Result Type	text	Non-standard Record Qualifier	(COLSTYP)	CRF

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Lab Example 1