A Brief Introducon to CDISC – SDTM and Data · PDF fileThe set of controlled terminology for the value or the presentaon

ABriefIntroduc/ontoCDISC–SDTM

andDataMapping

5/3/10 2

Agenda

Copyright©2010,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


5/3/10 6

Introduc/ontoCDISC


Non‐profitorganiza7onin2000

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/onDataDefini/onSpecifica/on(CRTDDS)–(define.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:HumanClinicalTrials–V3.1.1

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

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BeforeandAPer‐SDTM


Before APer

Domains√

StandardDomainNames

Χ

StandardVariables

StandardVariableNames

Domains√

StandardDomainNames

√

StandardVariables√

StandardVariableNames

√

Χ

Χ

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Before APer

•Reviewershadtofamiliarizethemselveswithuniquedomainnames,variablesandvariablenamesusedinanapplica7on‐TIMECONSUMING

•Goodpor7onofreview7mespent“cleaningupthedata”

•Inefficient,error‐prone

•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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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

Ques’aire

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)eitherasspecifiedbythestudyprotocol(e.g.,.exposure.),orprecedingorcoincidentwiththestudyassessmentperiod(e.g.,.concomitantmedica/ons.).

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

TheFindingsclass,capturestheobserva7onsresul7ngfromplannedevalua7onstoaddressspecificques7onssuchasobserva7onsmadeduringaphysicalexamina7on,laboratorytests,histopathology,ECGtes7ng,andques7onslistedonques7onnaires.

Inaddi7ontothethreegeneralobserva7onclasses,asubmissionwillgenerallyincludeasetofotherspecialpurposedatasetsofspecificstandardizedstructurestorepresentaddi7onalimportantinforma7on.

GeneralObserva/on

Classes

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Categoriza/onOfVariablesinSDTM


Variables

Roles Core/Being

GroupingQualifiersResultQualifiersSynonymQualifiersRecordQualifiersVariableQualifiers

1. Iden7fier2. Topic3. Timing4. Rule5. Qualifier‐

1. Required2. Expected3. Permissible

Iden/fier–

Iden/fiesthesubjectoftheobserva/on

Topic–

Iden/fiesthefocusoftheobserva/on

Timing–

Describesthestartandendofthe

observa/on

Qualifier–

Describesthetraitoftheobserva/on

Rule–

expressanalgorithmintheTrialDesign

model.

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Variables

Roles Core/Being




GroupingQualifiers–

areusedtogrouptogetheracollec/on

ofobserva/onswithinthesamedomain.

E.g.‐‐CAT,‐‐SCAT,‐‐GRPID,‐‐SPEC

ResultQualifiers–

describethespecificresultsassociatedwiththetopicvariable

forafinding.E.g.‐‐ORRES,‐‐STRESC,and

‐‐STRESN.

SynonymQualifiers–

specifyanalterna/venameforapar/cularvariableinanobserva/on.

E.g.‐‐MODIFYand‐‐DECOD,whichareequivalenttermsfora‐‐TRTor

‐‐TERMtopicvariable

RecordQualifiers–

defineaddi/onalaZributesoftheobserva/onrecordasawhole

(ratherthandescribingapar/cularvariablewithinarecord).

E.g.‐‐REASND,AESLIFE,

‐‐BLFL,‐‐POSand‐‐LOC.

VariableQualifiers–

areusedtofurthermodifyordescribeaspecificvariablewithin

anobserva/onandisonlymeaningfulinthecontextofthe

variabletheyqualify.

E.g.‐‐ORRESU,‐‐ORNHI,and‐‐ORNLO

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Variables

Roles Core/Being




RequiredVariables–

– Variablesneedtobeinthedomains

– Theirvaluescannotbenull

ExpectedVariables–

– Variablesneedtobeinthedomains

– Theirvaluescanbenull

PermissibleVariables–

– Variablesmaybepresentinthedomains–

canbeincludedasneeded

5/3/10 18Copyright©2010,CytelSta7s7calSo:ware&ServicesPvt.Ltd.

AllRightsReserved.

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


AllRightsReserved.

ExampleEventsData(MH)

Topic Identifiers

Timing

Qualifiers



AllRightsReserved.

Characteris/csofSDTMDomains

Domains–

1. Domain:Collec7onofobserva7onswithcommontopic.Generallyeachdomainisrepresentedbyadataset.

2. Eachdomainhasauniquetwo‐characterdomainname(e.g.,AE,CM,VS)

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


AllRightsReserved.

Characteris/csofSDTMVariables

Variables–

1. VariableName:limitedto8‐chars

2. Date/7meformat–ISO8601isatextstringYYYY‐MM‐DDThh:mm:ss(notaSASformat)

3. Controlledterminology–

1. CT(**)publishedexternally(ex:MedDRAorfollowCDISC‐specificterminology)

2. CT(*)valuefromasponsor‐definedcodelist

5/3/10 24

ConceptsofDataMapping


MappingProcess

SourceDatasets:StandardAe.g.:Client’slegacystandarddatasets

TargetDatasets:StandardBe.g.:CDISCSDTMCDISCADaMClient’snewstandards

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DataMapping–Step1MappingDomains


DEMODM

TargetDomains SourceDomains

AE

CM

AEV

COMVAR

CONMED

…..

…..

5/3/10 26

DataMapping–Step2MappingVariables


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

DataMapping–Step3MappingVariables‐Logic


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

5/3/10 28

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

5/3/10 31

AutomatedTool‐


MapGenie

5/3/10 32

References


1.  Prac7calMethodsforCrea7ngCDISCSDTMDomainDataSetsfromExis7ngData‐RobertW.Graebner,Quin7les,Inc.,OverlandPark,KS

2.  SDTM‐‐3.1.1Implementa7onGuide.pdf

3.  StudyDataTabula7onModelv1.1.pdf


AllRightsReserved.

5/3/10 34

EmailAddress

AninditaBhabacharjee–

[email protected]


Documents

A Brief Introducon to CDISC – SDTM and Data · PDF fileThe set of controlled terminology for the value or the presentaon