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This is an example of the ADLB dataset and associated metadata. This is just an example and does not mean to indicate that ADLB must be used as the dataset name, nor are the parameters described necessarily those that would be used in a particular study. 

Dataset wrap
Nameadlb
Dataset2
tableidadlb

Row

...

STUDYID

...

STUDYID

USUBJID

TRTP

TRT01P

TRTA

TRT01A

ADT

ADY

AVISIT

AVISITN

PARAM

PARAMCD

PARAMN

PARCAT1

AVAL

AVALC

BASECHGPCHGABLFLANL01FLLBSTNRCANRLOANRHIANRINDLBLOINCLBSPECRANDFLSAFFLTRTSDTTRTEDTLBCLSIG

LBSEQ

VISITNUM

LBDTC

1A123A2001

...

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Placebo02JAN2021

-6

SCREENING1Leukocytes (10^9/L)

...

WBC6HEMATOLOGY11.0
11.0

YY
4.511.0
26464-8BLOODYY2021-01-082021-01-28
112021-01-02
2A123

...

A2001PlaceboPlaceboPlaceboPlacebo

...

02JAN2021-6SCREENING1RBC (10^12/L)RBC8HEMATOLOGY5.4
5.4

YY
4.76.1
33051-4BLOODYY2021-01-082021-01-28
212021-01-02
3A123A2001

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Placebo02JAN2021-6SCREENING1Platelets (10^9/L)PLAT7HEMATOLOGY158
158

YY
150400
49497-1BLOODYY2021-01-082021-01-28
312021-01-02
4A123A2001

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Placebo02JAN2021-6SCREENING1Hemoglobin (g/dL)HGB5HEMATOLOGY14.5
14.5

YY
1418
718-7BLOODYY2021-01-082021-01-28
412021-01-02
5A123A2001

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Placebo02JAN2021-6SCREENING1Cholesterol (mg/dL)CHOL2CLINICAL CHEMISTRY229
229

YY
200

2093-3BLOODYY2021-01-082021-01-28
512021-01-02
6A123A2001

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...

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Placebo02JAN2021-6SCREENING1Albumin (g/L)ALB1CLINICAL CHEMISTRY4.0
4.0

YY
3.45.4
2862-1BLOODYY2021-01-082021-01-28
612021-01-02
7A123A2001

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Placebo02JAN2021-6SCREENING1Creatinine (mg/dL)CREAT3CLINICAL CHEMISTRY0.8
0.8

YY
0.71.3
2160-0BLOODYY2021-01-082021-01-28
712021-01-02
8A123A2001

...

Placebo

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Placebo

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...

Placebo02JAN2021

-6

SCREENING1Urine Specific GravityUSPGRAV9URINALYSIS




YY
1.0051.030
2965-2URINEYY2021-01-082021-01-28
812021-01-02
9A123A2001

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Placebo02JAN2021-6SCREENING1CannabinoidsCANNAB4DRUG TOXICITY
POSITIVE




NEGATIVE

ABNORMAL18282-4URINEYY2021-01-082021-01-28Y912021-01-02
Definexmltable
LevelDataset
PurposeAnalysis
NameADLB
DatasetDescriptionClassStructurePurposeKeysLocationDocumentation
ADLBLaboratory Analysis DatasetBASIC DATA STRUCTUREOne or more records per subject per analysis parameter per analysis visit per analysis timepointAnalysisSTUDYID, USUBJID, PARAM, PARAMCD, AVISIT,ADLB.xptADLB.SAS/SAP
Definexmltable
DatasetADLB
LevelVariable
PurposeAnalysis
NameADLB
Variable NameVariable LabelTypeCodelist/Controlled TermsCoreCDISC Notes

STUDYID

Study IdentifierChar
ReqLB.STUDYID
USUBJIDUnique Subject IdentifierChar
ReqLB.USUBJID
TRTPPlanned ProductChar
CondADSL.TRT01P
TRT01PPlanned Product for Period 01Char
CondADSL.TRT01P
TRTAActual ProductChar
CondADSL.TRT01A
TRT01AActual Product for Period 01Char
CondADSL.TRT01A
ADTAnalysis DateNum
PermLB.LBDTC captured in numeric format
ADYAnalysis Relative DayNum
PermLB.LBDY
AVISITAnalysis VisitChar
CondLB.VISIT
AVISITNAnalysis Visit (N)Num
PermLB.VISITNUM
PARAMParameterChar
ReqLB.LBTEST concatenated with LB.LBSTRESU - if PARCAT1=URINALYSIS then preface with Urine
PARAMCDParameter Codetext
ReqLB.LBTESTCD - if PARCAT1=URINALYSIS then preface with U
PARAMNParameter (N)Num
PermNumeric representation of PARAM. Sort by PARCAT! and PARAMCD and increment by 1 for each new LBTESTCD
PARCAT1Parameter Category 1Char
PermLB.LBCAT
AVALAnalysis ValueNum
CondLB.LBSTRESN
AVALCAnalysis Value (C)Char
CondLB.LBSTRESC where LB.LBSTRESN is null
BASEBaseline ValueNum
CondAVAL where ABLFL=Y
CHGChange from BaselineNum
PermAVAL-BASE - populated on ABLFL=Y records and post-baseline records
PCHGPercent Change from BaselineNum
Permderived as ((AVAL-BASE)/BASE)*100
ABLFLBaseline Record FlagCharYCondset to Y for last pre-product value within each PARAM
ANL01FLAnalysis Flag 01CharYCondset to Y for last value within PARAM and AVISIT
RANDFLRandomized Population FlagCharY;NCondADSL.RANDFL
SAFFLSafety Population FlagCharY;NCondADSL.SAFFL
TRTSDT

Date of First Exposure to Product

Jira
showSummaryfalse
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-192

Num
PermADSL.TRTSDT
TRTEDT

Date of Last Exposure to Product

Jira
serverIssue Tracker (JIRA)
serverId85506ce4-3cb3-3d91-85ee-f633aaaf4a45
keyTOBA-190

Num
PermADSL.TRTEDT
LBSEQSequence NumberNum
PermLB.LBSEQ
VISITNUMVisit NumberNum
PermLB.VISITNUM
LBDTCDate/Time of Specimen CollectionChar
PermLB.LBDTC