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Row 1:Shows a value collected in one unit, but converted to selected standard unit.
Rows 2-4:Show two 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, a sponsor may decide, e.g., to enter "0" into LBORNRLO and "199" in LBORNRHI. The sponsor 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

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SERUM

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YY

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

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SERUM

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Y

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

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SERUM

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Y

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

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SERUM

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YYY

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2006-07-19T08:3011Chemistry Day 1
5ABCLBABC-001-0015WBCLeukocytesHEMATOLOGY

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5.910^9/L5.95.910^9/L411

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WHOLE BLOOD

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YY

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

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WHOLE BLOOD

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YY

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

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WHOLE BLOOD

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YY

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

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7.5

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7.57.5

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5.009.00

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URINE

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YY

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

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NOT DONEInsufficient sampleSERUM

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2006-07-24T09:0066Chemistry Day 6
10ABCLBABC-001-00110CREATCreatinineCLINICAL CHEMISTRY

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0.9mg/Dl8080umol/L44.201114.9226

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SERUM

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2006-07-24T09:0066Chemistry Day 6
11ABCLBABC-001-00111WBCLeukocytesHEMATOLOGY

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5.910^9/L5.95.910^9/L411

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WHOLE BLOOD

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Y

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2006-07-24T09:0066Hematology Day 6
12ABCLBABC-001-00112CHOLCholesterolCLINICAL CHEMISTRY

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229mg/dL229229mg/dL0199HIGH

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SERUM

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2006-07-24T09:0066Chemistry Day 6
13ABCLBABC-001-00113WBCLeukocytesHEMATOLOGY

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9.810^9/L9.89.810^9/L411

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WHOLE BLOOD

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Y2006-07-27T06:4299Unscheduled Hematology Day 9
Dataset wrap
Namesupplb
Dataset2
RowSTUDYIDRDOMAINUSUBJIDIDVARIDVARVALQNAMQLABELQVALQORIGQEVAL
1ABCLBABC-001-001LBSEQ1BIOSIGBiological SignificanceNOTHERPRINCIPAL INVESTIGATOR
2ABCLBABC-001-001LBSEQ6BIOSIGBiological SignificanceNOTHERPRINCIPAL INVESTIGATOR