Mapping

ABriefIntroduc/ontoCDISCSDTM

andDataMapping

5/3/10 2

Agenda

Copyright2010,CytelSta7s7calSo:ware&ServicesPvt.Ltd.AllRightsReserved.

FlowofClinicalTrialsData

TheProblem

IntroducingCDISC

UnderstandingSDTM

ConceptsofDataMapping

References

5/3/10 3

FlowofClinicalTrialsData


Protocol

CRF Design

Actual Trial (Patient data collected in CRFs)

CDM (Patient data in CRFs converted

to Raw Datasets)

Raw Datasets Create Analysis Datasets

Create TLFs

FDA Submission/Review

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TheProblem


Protocol

CRF Design

Actual Trial (Patient data collected in CRFs)

CDM (Patient data in CRFs converted

to Raw Datasets)

Raw Datasets Create Analysis Datasets

Create TLFs

FDA Submission/Review

LACK OF STANDARDS

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IntroducingCDISC


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Introduc/ontoCDISC


Nonprotorganiza7onin2000

ClinicalDataInterchangeStandardsConsor7um

(CDISC)

1. Developmentofindustrystandardstosupportthea) electronicacquisi7onb) exchangec) submissionandd) archivingofclinicaltrialsdata

2. Developmentofglobal,plaYormindependentstandards5. Improvedataqualityandaccelerateproductdevelopment

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CDISCStandards


StudyDataTabula/onModel(SDTM) AnalysisDataModel

(ADaM) Opera/onalDataModel(ODM)

LaboratoryDataModel(LAB)

ProtocolRepresenta/on(PR)

StandardforExchangeofNonclinicalData(SEND)

CaseReportTabula/onDataDeni/onSpecica/on(CRTDDS)(dene.xml)

TrialDesignModel(TDM)ClinicalDataAcquisi/on

StandardsHarmoniza/on(CDASH)

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UnderstandingSDTM


Analysis Data Model (ADaM) Operational Data Model

(ODM) Laboratory Data Model

(LAB)

Protocol Representation (PR)

Standard for Exchange of Nonclinical Data (SEND)

Case Report Tabulation Data Definition Specification (CRTDDS) (define.xml)

Trial Design Model (TDM) Clinical Data Acquisition

Standards Harmonization (CDASH)

Study Data

Tabulation Model (SDTM)

Describes contents and structure of data collected during a clinical trial Purpose is to provide regulatory authority reviewers (FDA) a clear description of the structure, attributes and contents of each dataset and variables submitted as part of a product application

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UnderstandingSDTM


1.StudyDataTabula7onModelV1.1

2.StudyDataTabula7onModelImplementa7onGuide:HumanClinicalTrialsV3.1.1

hbp://www.cdisc.org/sdtm/

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BeforeandAPerSDTM


Before APer

Domains

StandardDomainNames

StandardVariables

StandardVariableNames

Domains

StandardDomainNames

StandardVariables

StandardVariableNames

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BeforeandAPerSDTM


Before APer

Reviewershadtofamiliarizethemselveswithuniquedomainnames,variablesandvariablenamesusedinanapplica7onTIMECONSUMING

Goodpor7onofreview7mespentcleaningupthedata

Inecient,errorprone

StandardDomainNames=EasytoFindData

StandardVariables/VariableNames=ImmediateFamiliaritywiththeData

Consistency

Minimallearningcurve

TIMEEFFICIENT

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CDISCSubmissionMetadataModel


Sevendis7nctmetadataabributes:

1. TheVariableName

2. Adescrip7veVariableLabel,upto40characters

3. ThedataType

4. Thesetofcontrolledterminologyforthevalueorthe

presenta7onformatofthevariable(ControlledTermsor

Format)

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BeforeandAPerSDTM


5. TheOriginorsourceofeachvariable

6. TheRoleofthevariable,whichdetermineshowthevariable

isusedinthedataset.

7. Commentsorotherrelevantinforma7onaboutthevariable

oritsdata.

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Types/ClassesofDomainsinSDTM


Interven/ons

Exposure

Conmeds

SubstUse

Findings

VitalsLabs

ECG

Incl/Excl SubjChar

Quesaire

MicroMSv3.1.2

MicroMBv3.1.2

DrugAcctPhysExam

PKParamv3.1.2

PKConcv3.1.2

Events

AE

Devia7onsv3.1.2

Disposi7on

MedHx

ClinicalEventsv3.1.2

Demog

SpecialDomains

Comments

SUPPQUAL

TrialDesign(5Tables)

RELREC

SubjElementsv3.1.2

SubjVisitsv3.1.2

TheInterven'onsclass,capturesinves/ga/onaltreatments,therapeu/ctreatments,andsurgicalproceduresthatareinten/onallyadministeredtothesubject(usuallyfortherapeu/cpurposes)eitherasspeciedbythestudyprotocol(e.g.,.exposure.),orprecedingorcoincidentwiththestudyassessmentperiod(e.g.,.concomitantmedica/ons.).

TheEventsclass,capturesplannedprotocolmilestonessuchasrandomiza7onandstudycomple7on(disposi7on),andoccurrencesorincidentsindependentofplannedstudyevalua7onsoccurringduringthetrial(e.g.,adverseevents)orpriortothetrial(e.g.,medicalhistory).

TheFindingsclass,capturestheobserva7onsresul7ngfromplannedevalua7onstoaddressspecicques7onssuchasobserva7onsmadeduringaphysicalexamina7on,laboratorytests,histopathology,ECGtes7ng,andques7onslistedonques7onnaires.

Inaddi7ontothethreegeneralobserva7onclasses,asubmissionwillgenerallyincludeasetofotherspecialpurposedatasetsofspecicstandardizedstructurestorepresentaddi7onalimportantinforma7on.

GeneralObserva/on

Classes

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Categoriza/onOfVariablesinSDTM


Variables

Roles Core/Being

GroupingQualiersResultQualiersSynonymQualiersRecordQualiersVariableQualiers

1.Iden7er2.Topic3.Timing4.Rule5.Qualier

1.Required2.Expected3.Permissible

Iden/er

Iden/esthesubjectoftheobserva/on

Topic

Iden/esthefocusoftheobserva/on

Timing

Describesthestartandendofthe

observa/on

Qualier

Describesthetraitoftheobserva/on

Rule

expressanalgorithmintheTrialDesign

model.

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Variables

Roles Core/Being




GroupingQualiers

areusedtogrouptogetheracollec/on

ofobserva/onswithinthesamedomain.

E.g.CAT,SCAT,GRPID,SPEC

ResultQualiers

describethespecicresultsassociatedwiththetopicvariable

foranding.E.g.ORRES,STRESC,and

STRESN.

SynonymQualiers

specifyanalterna/venameforapar/cularvariableinanobserva/on.

E.g.MODIFYandDECOD,whichareequivalenttermsforaTRTor

TERMtopicvariable

RecordQualiers

deneaddi/onalaZributesoftheobserva/onrecordasawhole

(ratherthandescribingapar/cularvariablewithinarecord).

E.g.REASND,AESLIFE,

BLFL,POSandLOC.

VariableQualiers

areusedtofurthermodifyordescribeaspecicvariablewithin

anobserva/onandisonlymeaningfulinthecontextofthe

variabletheyqualify.

E.g.ORRESU,ORNHI,andORNLO

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Variables

Roles Core/Being




RequiredVariables

Variablesneedtobeinthedomains

Theirvaluescannotbenull

ExpectedVariables

Variablesneedtobeinthedomains

Theirvaluescanbenull

PermissibleVariables

Variablesmaybepresentinthedomains

canbeincludedasneeded

5/3/10 18Copyright2010,CytelSta7s7calSo:ware&ServicesPvt.Ltd.

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AnExampleObserva7on

Qualifier

Unique Subject Identifier

Timing

Topic

Subject 123 had a serious and severe headache starting on study day 2



AllRightsReserved.

DatasetStructureSubject Identifier Topic Qualifier

Timing


AETERM USUBJID AESTDY AESEV AESER Unique Subject

Identifier

HEADACHE 123 2 SEVERE

Severity/ Intensity

Study Day of Start of Event

Reported Term for the Adverse Event

Serious Event

YES


AllRightsReserved.

DatasetStructure


AETERM USUBJID AESTDY AESEV AESER Unique Subject

Identifier

HEADACHE 123 2 SEVERE

Severity/ Intensity

Study Day of Start of Event

Reported Term for the Adverse Event

Serious Event

YES

Required Permissible Expected


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ExampleEventsData(MH)

Topic Identifiers

Timing

Qualifiers



AllRightsReserved.

Characteris/csofSDTMDomains

Domains

1.Domain:Collec7onofobserva7onswithcommontopic.Generallyeachdomainisrepresentedbyadataset.

2.Eachdomainhasauniquetwocharacterdomainname(e.g.,AE,CM,VS)

3.Variablesindomainbeginwiththedomainprex:(e.g.,VSTESTCD)


AllRightsReserved.

Characteris/csofSDTMVariables

Variables

1.VariableName:limitedto8chars2.Date/7meformatISO8601isatextstringYYYYMMDDThh:mm:ss(notaSASformat)

3.Controlledterminology1.CT(**)publishedexternally(ex:MedDRAorfollowCDISCspecicterminology)

2.CT(*)valuefromasponsordenedcodelist

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ConceptsofDataMapping


MappingProcess

SourceDatasets:StandardAe.g.:Clientslegacystandarddatasets

TargetDatasets:StandardBe.g.:CDISCSDTMCDISCADaMClientsnewstandards

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DataMappingStep1MappingDomains


DEMODM

TargetDomains SourceDomains

AE

CM

AEV

COMVAR

CONMED

..

..

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DataMappingStep2MappingVariables


DEMODM

TargetDomainVariables SourceDomainVariables

COMVAR

STUDYID COMVAR.STUDYID

DOMAIN

USUBJID COMVAR.USUBJID

SUBJID DM.SUBJID

RFSTDTC COMVAR._RFSTDT

RFENDTC COMVAR._RFENDTC

SITEID DM.SITEID

INVID

INVNAM

BRTHDTC DM.BRTHDTC

AGE DM.AGE

AGEU DM.AGEU

SEX DM.SEX

5/3/10 27

DataMappingStep3MappingVariablesLogic


DEMODMMappingLogic

COMVAR

STUDYID COMVAR.STUDYID Direct

DOMAIN Compute

USUBJID COMVAR.USUBJID Direct

SUBJID DM.SUBJID Direct

RFSTDTC COMVAR._RFSTDT DateConversion

RFENDTC COMVAR._RFENDTC Direct

SITEID DM.SITEID Direct

INVID Notmapping

INVNAM Notmapping

BRTHDTC DM.BRTHDTC Direct

AGE DM.AGE Direct

AGEU DM.AGEU Direct

SEX DM.SEX ValueConversion

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TypesofMapping


OnetoOneMapping

Dateofbirth

SourceCRFVariables SDTMVariables

BRTHDTC

SEX SEX

Weight VSORRES

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TypesofMapping


OnetoManyMapping

VISITDATE


DTC

DTC

DTC

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TypesofMapping


ManytoOneMapping

FUVisitDate


STUDYDAY

BaselineVisitDate

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AutomatedTool


MapGenie

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References


1. Prac7calMethodsforCrea7ngCDISCSDTMDomainDataSetsfromExis7ngDataRobertW.Graebner,Quin7les,Inc.,OverlandPark,KS

2. SDTM3.1.1Implementa7onGuide.pdf

3. StudyDataTabula7onModelv1.1.pdf


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5/3/10 34

EmailAddress

AninditaBhabacharjee

[email protected]


Documents

Mapping