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Jira

showSummary	false
server	Issue Tracker (JIRA)
serverId	85506ce4-3cb3-3d91-85ee-f633aaaf4a45
key	TOBA-52

Dataset wrap

Name	lb

Rowcaps

Row 1:

Shows a value collected in

...

1 unit, but converted to selected standard unit.
Rows 2-4:	Show

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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

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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,

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an applicant may decide,

...

for example, to enter "0" into LBORNRLO and "199" in LBORNRHI. The

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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.

Dataset2

Row	STUDYID	DOMAIN	USUBJID	LBSEQ	LBTESTCD	LBTEST	LBCAT	LBSCAT	LBORRES	LBORRESU	LBSTRESC	LBSTRESN	LBSTRESU	LBSTNRLO	LBSTNRHI	LBNRIND	LBSTAT	LBREASND	LBSPEC	LBMETHOD	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

...

		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

...

		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

10^9/L

4

11

...

WHOLE BLOOD

...

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

...

			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

...

			2006-07-19T08:30	1	1	Hematology Day 1
8	ABC	LB	ABC-001-001	8	PH	pH	URINALYSIS

...

7.5

...

7.5

...

5.00

9.00

...

URINE

...

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

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

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

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

10^9/L

4

11

...

WHOLE BLOOD

...

Y

2006-07-27T06:42

9

Unscheduled Hematology Day 9

Dataset wrap

Name	supplb

Dataset2

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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