cdisc migraon - cytel · • target structure flexible, not restricted to sdtm • data driven...
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CDISCMigra+on
PhUSE2010‐Berlin
47ofthetop50biopharmaceu+calfirmsuseCytelsoFwaretodesign,simulateandanalyzetheirclinicalstudies.
Source: The Pharm Exec 50—the world’s top 50 pharmaceutical companies according to PHARMACEUTICAL EXECUTIVE
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Presentation Objectives
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• Introduc+ons• CDISCMigra+onStrategies
• BenefitsofDeployingaMigra+onU+lity
• Ques+ons&Answers
CytelPresenters Title
IrvingDark VicePresident,ClinicalResearchServices
JimNigrelli PrincipalSta+s+calProgrammer
AjaySathe CEO,CytelIndia
Introductions
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CDISC Experience
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• Converteddatafrommorethan50trialstoSDTMcompliantdatasets
• Prac+celeaderswithextensiveCDISCexperience• RecentFDAApprovalusingdatamigratedtoCDISCbyCytel
• LicensedWebSDM™forcheckingSDTMcompliance
CDISCMIGRATIONSTRATEGIES
IrvingDark,VicePresidentClinicalResearchServices
JimNigrelli,PrincipalSta+s+calProgrammer
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Migration practices – Key components
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GapAnalysisTrialDesignAnnotatedCRFsDataMigra+onDefine.xmlQCWebSDM™
GAP Analysis
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• Itemiza+onandevalua+onoffilestosupportmigra+onac+vi+es
• Ini+atedpriortocommencingmigra+onac+vi+es• Documentinventory
• ReconcilesampleCRFsversussourcedata
• Comparisonofprotocolamendments/versionsagainstCRFversions
• Advantages:– Proac+veapproachratherthanreac+ve– Clarifiesthescopeandchallengesofmigra+onac+vi+es
– Iden+fiesdifferencesindatacollec+onformats
Trial Design
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• Domainthatcontainsaclearrepresenta+onofthedesignofaclinicaltrial– CreatedpriortoCRFannota+onanddatamigra+on
– Experienceneededtocreatethetrialdesigndataset:• SDTMTrialDesignConcepts
• Experiencewithkeyclinicaldocuments(e.g.Protocol,SAP,DataSets,CSR)
– Examples:• Standardiza+onacrossstudies• Iden+fyingtrialARMSandtrialVISITS
• Plannedperprotocolversusactual
CRF Annotation
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• TheannotatedCRFprovidesthemigra+onteamwithaclearpresenta+onofSDTMvariables
• CompletedfollowingtheGAPanalysisandpriortomigra+on• ExperienceneededtocreatetheannotatedCRF:
– KnowledgeoftheSDTMImplementa+onGuideandMetadataSubmissionGuidelines(chapter4–GuidelinesforAnnota+ngCRFs)
– Standarddatamanagementprinciples
Data Migration
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• CurrentlyusingSASprogramstomigratedata:– UseSASandExcel– Mappingspecifica+onsgenerated(Excel)
– SASMacrostoassistinstandardizingthemigra+onprocess(e.g.ISOdateconversion,SDTMtemplates,ControlTerminologyLook‐ups)
DEFINE.XML
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• Metadatadescribingtheformatandcontentofthedatasets
• In‐HouseU+lity:– SASGenerated– Metadata/Code‐listdriven
– CRFpagelinks– Commentsinser+on
Migration QC
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• QCofMigra+onofClinicalData
• Deriva+onofSDTMvariables
• Genera+onofDefine.xml• CompliancetoSDTMstandards
• KeyComponents:– DataAccountability– Sourcedatachecks– Define.xml
– Addi+onalQCchecks– SDTMCompliance
WebSDM™
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• Datareviewtoolusedtovalidatethecomplianceofdatasetsanddefine.xmltoSDTMstandards
• Iden+fies:– Trueerrors– Datarelatederrors(e.g.start/enddates)– Falseerrors(e.g.un+l‐lesstestresults)
BENEFITSOFDEPLOYINGAMIGRATIONUTILITY
AjaySathe,CEOCytelIndia
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Automate – What and how
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• Metadataapproach
• Tasksmostamenabletoautoma+on:
– Mappingofvariables(mappingspecsdocument)
– MappingCodeGenera+on
– Valida+ngthemappeddatasets
Automate – What and how
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• AccountforallofSourceData• LoadTargetDatadefini+on(SDTMorother)
• CreateCustomDomains
• Defineglobalterminology
• Definepre‐processinglogic,e.g.,TRANSPOSE• Supplymappinglogic
– Talkabouttheseventypesofmappinglogic?
• Pushthebukon!– (no,it’snotthatsimple,ofcourse.Verbalexplana+on)
So, what’s new in this approach?
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• TargetStructureflexible,notrestrictedtoSDTM
• DataDrivenapproach–thelogicresidesindata
– Logicstoredinmappingdescrip+ondatasets.
• Self‐documen+ng.Generatemappingspecifica+oninparallel
• Meta‐programming.GenerateSAS®codethatdoesthejob
• Transforma+ontypes–versa+le&comprehensive– Automa/c–matchnameandtype– DataTypeconversion– RenameVariables– ValueConversions,usingControlledTerminology– DateConversions(e.g.ISODATE)– Concatena/onorParsing/spliHng– Compute–userdefinedSAS®statements
The Outputs
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• AccountforallofSourceData• MappingSpecifica+onsDocument
• SAS®codeforMapping
• MigratedDatasets
Step 1: Project-level settings
©2010CytelInc.Private&Confiden+alwww.cytel.com 19
SelectSDTMVersionhere
Setvariousfolderpathshere
Step 2: Dataset level settings
©2010CytelInc.Private&Confiden+alwww.cytel.com 20
Pickasourcedataset
Pickatargetdataset(inthiscaseSDTM)
Mappingdefini+onbeginstoappear.
No+cethe“WHERE”
Step 3 – Global controlled terminology
©2010CytelInc.Private&Confiden+alwww.cytel.com 21
Loadcontrolledterminologyfroman
Excelfile…
…and/or,addittomappingmetadata
manually
Step 4 – Mapping the variables
©2010CytelInc.Private&Confiden+alwww.cytel.com 22
“Auto”mappingusingsmartrules
Therulesappearhere;Useroverridepossible
Step 4 – Auto-mapping rules
©2010CytelInc.Private&Confiden+alwww.cytel.com 23
“Auto”mappingusingsmartrules
Therulesappearhere;Useroverridepossible
Step 5 – Mapping the variables
©2010CytelInc.Private&Confiden+alwww.cytel.com 24
Selectthedomain
CorrespondingSource&Targetsappear
Usersetspre‐processingandtransforma+onlogic
Mappingsspecsaresaved.Self‐documen+ng!
Transformation types
©2010CytelInc.Private&Confiden+alwww.cytel.com 25
• Auto
• Convert Data Types
• Rename
• Drop
• Convert Values
• Convert ISODate
• Concatenate
• Extract
• Compute (any user-defined SAS® code logic)
The generated code
©2010CytelInc.Private&Confiden+alwww.cytel.com 26
The generated code
©2010CytelInc.Private&Confiden+alwww.cytel.com 27
Thankyou.
QuesCons?
Euro/UKcontact:LaurentSpiess,Ph.D.GeneralManagerEuropelaurent@cytel.comPhone:+33673861254
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Innova+onsinAdap+veClinicalTrialDesigns
www.cytel.com
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