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Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-52

Dataset wrap
Namelb
Rowcaps
Row 1:Shows a value collected in one 1 unit, but converted to selected standard unit.
Rows 2-4:Show two 2 records for Alkaline Phosphatase 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 rows 2 and 3) and flag it as Derived 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 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, a sponsor an applicant may decide, e.g.for example, to enter "0" into LBORNRLO and "199" in LBORNRHI. The sponsor 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
RowSTUDYIDDOMAINUSUBJIDLBSEQLBTESTCDLBTESTLBCATLBSCATLBORRESLBORRESULBSTRESCLBSTRESNLBSTRESULBSTNRLOLBSTNRHILBNRINDLBSTATLBREASNDLBSPECLBMETHODLBBLFLLBFASTLBDRVFLLBUSCHFLLBDTCLBDYLBNOMDYLBNOMLBL
1ABCLBABC-001-0011ALBAlbuminCLINICAL CHEMISTRYLIVER FUNCTION30kg/m33.03g/dL3.55LOW

SERUM
YY

2006-07-19T08:3011Chemistry Day 1
2ABCLBABC-001-0012ALPAlkaline PhosphataseCLINICAL CHEMISTRYGENERAL398U/L398398U/L40160


SERUM

Y

2006-07-19T08:3011Chemistry Day 1
3ABCLBABC-001-0013ALPAlkaline PhosphataseCLINICAL CHEMISTRYGENERAL350U/L350350U/L40160


SERUM

Y

2006-07-20T12:3021Chemistry Day 1
4ABCLBABC-001-0014ALPAlkaline PhosphataseCLINICAL CHEMISTRYGENERAL374U/L374374U/L40160


SERUM
YYY
2006-07-19T08:3011Chemistry Day 1
5ABCLBABC-001-0015WBCLeukocytesHEMATOLOGY
5.910^9/L5.95.910^9/L411


WHOLE BLOOD
YY

2006-07-19T08:3011Hematology Day 1
6ABCLBABC-001-0016LYMLELymphocytes/ LeukocytesHEMATOLOGYDIFFERENTIAL6.7%6.76.7%2540LOW

WHOLE BLOOD
YY

2006-07-19T08:3011Hematology Day 1
7ABCLBABC-001-0017NEUTNeutrophilsHEMATOLOGYDIFFERENTIAL5.110^9/L5.15.110^9/L28


WHOLE BLOOD
YY

2006-07-19T08:3011Hematology Day 1
8ABCLBABC-001-0018PHpHURINALYSIS
7.5
7.57.5
5.009.00


URINE
YY

2006-07-19T08:3011Urinalysis Day 1
9ABCLBABC-001-0019ALBAlbuminCLINICAL CHEMISTRYLIVER FUNCTION







NOT DONEInsufficient sampleSERUM




2006-07-24T09:0066Chemistry Day 6
10ABCLBABC-001-00110CREATCreatinineCLINICAL CHEMISTRY
0.9mg/dL8080umol/L44.201114.9226


SERUM




2006-07-24T09:0066Chemistry Day 6
11ABCLBABC-001-00111WBCLeukocytesHEMATOLOGY
5.910^9/L5.95.910^9/L411


WHOLE BLOOD

Y

2006-07-24T09:0066Hematology Day 6
12ABCLBABC-001-00112CHOLCholesterolCLINICAL CHEMISTRY
229mg/dL229229mg/dL0199HIGH

SERUM




2006-07-24T09:0066Chemistry Day 6
13ABCLBABC-001-00113WBCLeukocytesHEMATOLOGY
9.810^9/L9.89.810^9/L411


WHOLE BLOOD



Y2006-07-27T06:4299Unscheduled Hematology Day 9

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