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Copyright © 2016 Akana and Intelent Inc. All rights reserved. Powering the API Economy
How a Metadata Repository enables dynamism & automation in SDTM-like dataset generation
PhUSE 2016 – DH05 Judith Goud, Akana Priya Shetty, Intelent
Copyright © 2016 Akana and Intelent Inc. All rights reserved. Powering the API Economy
Outline
• Trends-Dynamismandautoma1onindataintegra1on
• BusinessProcesses-Tradi1onalandEnhancedApproaches
• Transforma1onalMetadataManagement
• MetadataDrivenClinicalDataFlow
• UseCaseDemo• MetadataStorageandExtrac1on• DynamicProgramExecu1on• TargetDatasetGenera1on• SourcetoTargetTransforma1ons
• Conclusion
Copyright © 2016 Akana and Intelent Inc. All rights reserved. Powering the API Economy
Trends - Dynamism and Automation in Integration
Drivers Dynamism
Automation
• Source, target and transformation metadata vary across studies
• Physical storage, data transfer mechanism and relevant data dictionaries may vary across studies
• Important to minimize code change, transformation pre-processing in ingestion layer
• Dynamic transformation rules needed
• Cost and time efficiency, adoption within enterprise
• Key is to minimize code change
• Key is to automate data delivery in usable format with minimal manual intervention
• Store structures in appropriate hierarchy and data lifecycle stages
• Plan either by leveraging existing metadata or manufactured metadata
• A robust user interface or means of configuration can address gaps
• High availability of data to points of analysis • From disparate sources: raw, integrated,
cleansed/ not cleansed, reconciled, aggregated, etc.
• Based on use cases: interim analysis, submission, central monitoring, etc.
Copyright © 2016 Akana and Intelent Inc. All rights reserved. Powering the API Economy
Traditional Business Process
Sta$s$cianorSta$s$cal
Programmer Sta$s$cal
Programmers Tabula$onDatasetand
Valida$onSpecifica$ons
PriorStudy
Datasets
SDTMStandard
Protocol/SAP
ValidatedTabula$onDatasets
Copyright © 2016 Akana and Intelent Inc. All rights reserved. Powering the API Economy
Enhanced Business Process
Sta$s$cianorSta$s$cal
Programmer Sta$s$cal
Programmers Tabula$onDatasetand
Valida$onSpecifica$ons
PriorStudy
Datasets
SDTMStandard
Protocol/SAP
ValidatedTabula$onDatasets
MetadataRepository
StandardsIndustryDefinedSeman1cs
CDISCSDTMStandardCDISCADaMStandard
InternalDataTabula1onStandardStudySpecificMetadataProtocolStructureTime&EventsScheduleSta1s1calAnalysisPlanPrior&CurrentStudyDatasetSpecsPrior&CurrentStudyValida1onSpecs
Export/Rendering
Integra1on/Import
Integra1on/Export
Copyright © 2016 Akana and Intelent Inc. All rights reserved. Powering the API Economy
Transformational Metadata Management
Copyright © 2016 Akana and Intelent Inc. All rights reserved. Powering the API Economy
TARGETDATA(SAS)
MetadataViews(Oracle)(Global,TA,Product,Study)
ODSandDATAPROCESSINGLAYER(SAS)
METADATAMANAGEMENTSYSTEM(AKANASeman1csManager)
DataValida1onIssues
SourceDataStructure
TargetDataStructure
ReferenceDataStructure
MasterDataStructure
Transforma1onRules
SDTM+/-
ADaM
OTHER
SOURCEDATA(SAS)
EDC/CDMSData
PARTNERS/CRO/LABData
ReferenceData
MasterData
OtherData
Metadata Driven Clinical Data Flow
Copyright © 2016 Akana and Intelent Inc. All rights reserved. Powering the API Economy
Source and Target Metadata extracted from Semantics Manager
StructuralandTransforma1onalMetadataextractedfromSMdrivesdynamicprogramforgenera1ngtargetdatasets
Deriva1onTypes
Deriva1onorderofexecu1on
Copyright © 2016 Akana and Intelent Inc. All rights reserved. Powering the API Economy
Dynamic Program Execution to generate Target Datasets
SASMacroscorrespondingtoSMtransforma1onalmetadata
ExecuteDynamicProgramasBatchorIndividualMode
Copyright © 2016 Akana and Intelent Inc. All rights reserved. Powering the API Economy
Metadata driven Source to Target Transformation Examples
MergewithMedDRAdic1onarypopula1ngrequiredsubmissionvariablesintarget
Updatetransforma1onmetadatainSM(Addahyphen)forUSUBJIDrule–automatedupdateintargetdata
SourceDateUpdatereflectedISO8601formatinTarget
Copyright © 2016 Akana and Intelent Inc. All rights reserved. Powering the API Economy
Conclusion
• Highavailabilityofdata(source,integrated,andstandardized)facilitatesrapidinsightsandaccelerated1melinesforsubmissions
• Dynamicandautomatedgenera1onofdatasetsacrossstudieswithminimalcustomiza1onnecessaryresultsincostand1mesavings
• Acceleratedresponsetometadataupdatedriverslikenewversionsofstandardsand/ornewregula1onsfacilitateregulatorycompliance
• Reusabilityofstandardalgorithmsresultinenhancedefficienciesforvalida1on
• Dynamicandautomatedprocessesdrivenbymetadatalimittheneedofchangecontrol
• Fulltraceabilityforaudittrackingprovidescontrolledstandardsmanagement
Theuseofacentralizedrepositorytomanageandgovernmetadataandstandardsinaflexiblesourceagnos1cdataintegra1onplaaormprovidesthefollowingadvantages:
Copyright © 2016 Akana and Intelent Inc. All rights reserved. Powering the API Economy
Q&A and Contact
Powering the API Economy
JudithGoudSeniorSolu1onArchitectBioPharmaEurope6-9TheSquare,StockleyPark,Uxbridge,UB111FW,[email protected]:+31612417026www.akana.com
PriyaShe7yDirector500AlexanderPark,Princeton,[email protected]:+16466378583www.intelent.com