Laboratory Test Results (LB)

Example

TOBA-52 - Getting issue details... STATUS

Row 1:	Shows a value collected in 1 unit, but converted to selected standard unit.
Rows 2-4:	Show 2 records for alkaline phosphatase that were collected 1 day apart and are expected to be reported together. Row 4 shows how to create a derived record (average of the rows 2 and 3) and flag it as derived (LBDRVFL = "Y") as well as the record to use as baseline (LBBLFL = "Y").
Rows 6-7:	Show a suggested use of the LBSCAT variable. It could be used to further classify types of tests within a laboratory panel (e.g., "DIFFERENTIAL").
Row 9:	Shows the proper use of the LBSTAT variable to indicate "NOT DONE," when the fact that the test was done was documented.
Row 12:	The subject had cholesterol measured. The normal range for this test is <200 mg/dL. The value <200 may not be used in the normal range variables LBORNRHI or LBSTNRHI; however, an applicant may decide, for example, to enter "0" into LBORNRLO and "199" in LBORNRHI. The applicant must define the appropriate value for all of the normal range variables.
Row 13:	Shows the use of LBUSCHFL to indicate that the test result was obtained from an unscheduled blood collection. In this case, the subject was moribund and a blood sample was taken prior to sacrifice.
Rows 1, 6:	Use records in the SUPPLB dataset example to show biological significance assigned by the investigator for test results.

lb.xpt

Row	STUDYID	DOMAIN	USUBJID	LBSEQ	LBTESTCD	LBTEST	LBCAT	LBSCAT	LBORRES	LBORRESU	LBSTRESC	LBSTRESN	LBSTRESU	LBSTNRLO	LBSTNRHI	LBNRIND	LBSTAT	LBREASND	LBSPEC	LBBLFL	LBFAST	LBDRVFL	LBUSCHFL	LBDTC	LBDY	LBNOMDY	LBNOMLBL
1	ABC	LB	ABC-001-001	1	ALB	Albumin	CLINICAL CHEMISTRY	LIVER FUNCTION	30	kg/m3	3.0	3	g/dL	3.5	5	LOW			SERUM	Y	Y			2006-07-19T08:30	1	1	Chemistry Day 1
2	ABC	LB	ABC-001-001	2	ALP	Alkaline Phosphatase	CLINICAL CHEMISTRY	GENERAL	398	U/L	398	398	U/L	40	160				SERUM		Y			2006-07-19T08:30	1	1	Chemistry Day 1
3	ABC	LB	ABC-001-001	3	ALP	Alkaline Phosphatase	CLINICAL CHEMISTRY	GENERAL	350	U/L	350	350	U/L	40	160				SERUM		Y			2006-07-20T12:30	2	1	Chemistry Day 1
4	ABC	LB	ABC-001-001	4	ALP	Alkaline Phosphatase	CLINICAL CHEMISTRY	GENERAL	374	U/L	374	374	U/L	40	160				SERUM	Y	Y	Y		2006-07-19T08:30	1	1	Chemistry Day 1
5	ABC	LB	ABC-001-001	5	WBC	Leukocytes	HEMATOLOGY		5.9	10^9/L	5.9	5.9	10^9/L	4	11				WHOLE BLOOD	Y	Y			2006-07-19T08:30	1	1	Hematology Day 1
6	ABC	LB	ABC-001-001	6	LYMLE	Lymphocytes/ Leukocytes	HEMATOLOGY	DIFFERENTIAL	6.7	%	6.7	6.7	%	25	40	LOW			WHOLE BLOOD	Y	Y			2006-07-19T08:30	1	1	Hematology Day 1
7	ABC	LB	ABC-001-001	7	NEUT	Neutrophils	HEMATOLOGY	DIFFERENTIAL	5.1	10^9/L	5.1	5.1	10^9/L	2	8				WHOLE BLOOD	Y	Y			2006-07-19T08:30	1	1	Hematology Day 1
8	ABC	LB	ABC-001-001	8	PH	pH	URINALYSIS		7.5		7.5	7.5		5.00	9.00				URINE	Y	Y			2006-07-19T08:30	1	1	Urinalysis Day 1
9	ABC	LB	ABC-001-001	9	ALB	Albumin	CLINICAL CHEMISTRY	LIVER FUNCTION									NOT DONE	Insufficient sample	SERUM					2006-07-24T09:00	6	6	Chemistry Day 6
10	ABC	LB	ABC-001-001	10	CREAT	Creatinine	CLINICAL CHEMISTRY		0.9	mg/dL	80	80	umol/L	44.201	114.9226				SERUM					2006-07-24T09:00	6	6	Chemistry Day 6
11	ABC	LB	ABC-001-001	11	WBC	Leukocytes	HEMATOLOGY		5.9	10^9/L	5.9	5.9	10^9/L	4	11				WHOLE BLOOD		Y			2006-07-24T09:00	6	6	Hematology Day 6
12	ABC	LB	ABC-001-001	12	CHOL	Cholesterol	CLINICAL CHEMISTRY		229	mg/dL	229	229	mg/dL	0	199	HIGH			SERUM					2006-07-24T09:00	6	6	Chemistry Day 6
13	ABC	LB	ABC-001-001	13	WBC	Leukocytes	HEMATOLOGY		9.8	10^9/L	9.8	9.8	10^9/L	4	11				WHOLE BLOOD				Y	2006-07-27T06:42	9	9	Unscheduled Hematology Day 9

$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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supplb.xpt

Row	STUDYID	RDOMAIN	USUBJID	IDVAR	IDVARVAL	QNAM	QLABEL	QVAL	QORIG	QEVAL
1	ABC	LB	ABC-001-001	LBSEQ	1	BIOSIG	Biological Significance	N	OTHER	PRINCIPAL INVESTIGATOR
2	ABC	LB	ABC-001-001	LBSEQ	6	BIOSIG	Biological Significance	N	OTHER	PRINCIPAL INVESTIGATOR

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Example

Rows 1-3:	Show urine analysis for glucose.
Row 1:	Shows an example of a predose urine collection interval (from 4 hours prior to dosing until 15 minutes prior to dosing) with a negative value for LBELTM that reflects the end of the interval in reference to dosing (LBTPTREF), the date of which is recorded in LBRFTDTC.
Rows 2-3:	Show an example of postdose urine collection intervals with values for LBELTM that reflect the end of the intervals in reference to the fixed reference LBTPTREF, the date of which is recorded in LBRFTDTC.
Row 4:	Shows an assessment of color was also included for the sample collected from 8 to 16 hours postdose.

lb.xpt

Row	STUDYID	DOMAIN	USUBJID	LBSEQ	LBTESTCD	LBTEST	LBCAT	LBORRES	LBORRESU	LBORNRLO	LBORNRHI	LBSTRESC	LBSTRESN	LBSTRESU	LBSTNRLO	LBSTNRHI	LBSPEC	LBDTC	LBENDTC	LBDY	LBENDY	LBNOMDY	LBTPT	LBTPTNUM	LBELTM	LBTPTREF	LBRFTDTC
1	ABC	LB	ABC-001-001	1	GLUCOSE	Glucose	URINALYSIS	7	mg/dL	1	15	0.39	0.39	mmol/L	0.06	0.83	URINE	2006-07-19T04:00	2006-07-19T07:45	1	1	1	Predose	1	-P15M	Day 1 dose	2006-07-19T08:00
2	ABC	LB	ABC-001-001	2	GLUCOSE	Glucose	URINALYSIS	11	mg/dL	1	15	0.61	0.61	mmol/L	0.06	0.83	URINE	2006-07-19T08:00	2006-07-19T16:00	1	1	1	0-8 hours after dosing	2	P8H	Day 1 dose	2006-07-19T08:00
3	ABC	LB	ABC-001-001	3	GLUCOSE	Glucose	URINALYSIS	9	mg/dL	1	15	0.50	0.50	mmol/L	0.06	0.83	URINE	2006-07-19T16:00	2006-07-20T00:00	1	2	1	8-16 hours after dosing	3	P16H	Day 1 dose	2006-07-19T08:00
4	ABC	LB	ABC-001-001	4	COLOR	Color	URINALYSIS	YELLOW				YELLOW					URINE	2006-07-19T16:00	2006-07-20T00:00	1	2	1	8-16 hours after dosing	3	P16H	Day 1 dose	2006-07-19T08:00

$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

Example

This is an example of urine glucose test records, 1 with a result and 1 with no result because the test was not performed due to sample being insufficient.

Row 1:	Shows an example of a urine glucose test record that was originally recoded in the collection system as "-" (negative sign). Instead, the results show the text value associated with that code in both LBORRES and LBSTRESC.
Row 2:	Shows an example of a serum glucose test that was not performed because the sample was exhausted, and the applicant felt it was necessary to report a record documenting the reason why the test was not performed.

lb.xpt

Row	STUDYID	DOMAIN	USUBJID	LBSEQ	LBTESTCD	LBTEST	LBCAT	LBORRES	LBORRESU	LBSTRESC	LBSTRESN	LBSTRESU	LBSTAT	LBREASND	LBSPEC	LBMETHOD	LBBLFL	LBDTC	LBDY	LBNOMDY
1	ABC	LB	ABC-001-001	1	GLUCOSE	Glucose	URINALYSIS	NEGATIVE		NEGATIVE					URINE			2006-07-19T04:00	1	1
2	ABC	LB	ABC-001-002	1	GLUCOSE	Glucose	CLINICAL CHEMISTRY						NOT DONE	SAMPLE EXHAUSTED	SERUM			2006-07-24T08:00	5	5

$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

Example

This is an example of albumin tests done for pooled subjects. Samples from subjects ABC-009, ABC-010, and ABC-011 were pooled, and their results were reported as pooled results. The associated POOLDEF rows follow, to illustrate the pool definition.

Rows 1-3: Show the results pooled from subjects ABC-009, ABC-010, and ABC-011, with POOLID of POOL001.

lb.xpt

Row	STUDYID	DOMAIN	USUBJID	POOLID	LBSEQ	LBTESTCD	LBTEST	LBCAT	LBORRES	LBORRESU	LBSTRESC	LBSTRESN	LBSTRESU	LBSPEC	LBMETHOD	LBBLFL	LBDTC	LBDY	LBNOMDY
1	ABC	LB		POOL001	1	ALB	Albumin	CLINICAL CHEMISTRY	3.0	g/dL	3.0	3.0	g/dL	SERUM			2006-07-19T04:00	1	1

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pooldef.xpt

Row	STUDYID	POOLID	USUBJID
1	ABC	POOL001	ABC-009
2	ABC	POOL001	ABC-010
3	ABC	POOL001	ABC-011

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TOBA-278 - Getting issue details... STATUS

Example

The following example shows cases of categorical data that cannot be considered as numeric, even though in some cases it appears that the data includes a number. The allowed values in these ranges should be defined in the data definition file. Samples were collected at one point and not over a given interval.

Rows 1-2:	Show an example of urine ketones tests performed for 2 animals. The test's values are categorical, using a list (i.e., NEGATIVE, TRACE, SMALL, MODERATE, LARGE), the range of which is referenced in LBSTRNRC. LBSTRESN is left null.
Rows 3-4:	Show an example of urine bilirubin tests performed for 2 animals. The test's values are categorical, using a list (i.e., NEGATIVE, 1+, 2+, 3+) which represents qualitative levels. Although the 1+, 2+, and 3+ values could be converted to numbers, the values represent a nonnumeric category based on an arbitrary scale; therefore, LBSTRESN is left blank.
Rows 5-6:	Show an example of urine protein tests performed for 2 animals. The test's values are categorical, using a list (i.e., NEGATIVE, TRACE, 30, 100). Although the 30 and 100 values could be converted as numbers, the values represent a nonnumeric label of the result; therefore, LBSTRESN is left blank.

lb.xpt

Row	STUDYID	DOMAIN	USUBJID	LBSEQ	LBTESTCD	LBTEST	LBCAT	LBORRES	LBSTRESC	LBSTNRC	LBSPEC	LBDTC	LBDY	LBNOMDY
1	ABC	LB	ABC-001-001	1	KETONES	Ketones	URINALYSIS	SMALL	SMALL	NEGATIVE TO LARGE	URINE	2006-07-19	1	1
2	ABC	LB	ABC-001-002	2	KETONES	Ketones	URINALYSIS	LARGE	LARGE	NEGATIVE TO LARGE	URINE	2006-07-19	1	1
3	ABC	LB	ABC-001-001	3	BILI	Bilirubin	URINALYSIS	NEGATIVE	NEGATIVE	NEGATIVE TO 3+	URINE	2006-07-19	1	1
4	ABC	LB	ABC-001-002	4	BILI	Bilirubin	URINALYSIS	2+	2+	NEGATIVE TO 3+	URINE	2006-07-19	1	1
5	ABC	LB	ABC-001-001	5	PROT	Protein	URINALYSIS	TRACE	TRACE	NEGATIVE TO 100	URINE	2006-07-19	1	1
6	ABC	LB	ABC-001-002	6	PROT	Protein	URINALYSIS	30	30	NEGATIVE TO 100	URINE	2006-07-19	1	1

$warningHtml

Dataset Wrapper Debug Message

Please add a row column to your dataset.

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Laboratory Test Results (LB)