TMFReferenceModelDIATrialMasterFileReferenceModelEDMReferenceModelDIADocumentandRecordsManagementSpecialInterestAreaCommunityinitiativesince2008StandardizationeffortfortheindustrywitheCTDbackboneVersion1launchedin2008,updateintheworksExtensionsofthemodelareindevelopmentInterco...
DIATrialMasterFileReferenceModelEDMReferenceModelDIADocumentandRecordsManagementSpecialInterestAreaCommunityinitiativesince2008StandardizationeffortfortheindustrywitheCTDbackboneVersion1launchedin2008,updateintheworksExtensionsofthemodelareindevelopmentInterconnectswithTMFReferenceModelintrialrelatedsubmissiondocumentationEnsuremappingoftaxonomyandalignmentofmetadataICHGCPSection8.2–8.4“Theminimumlistofessentialdocumentsthathasbeendeveloped.....”ICHGCPdoesNOTprovideacomprehensivecontentslistfortheTMFExamplesofmissingdocumentation:ElectronicsystemsDatamanagementandstatisticalmethodologySafetymonitoringWhyaTMFReferenceModel?OtherbusinessrecordsTheTrialMasterFileSupportingfilese.g.computerSDLCfiles;GMPmanufacturingfiles;vendorselectionfilesUsuallyconsideredoutsidethescopeoftheTMFOthertrial-relatedrecordsthat“permitevaluationoftheconductofthetrialandqualityofdataproduced”Minimumlistofessentialdocuments,asdefinedbyICHGCP,Chapter8TheTrialMasterFileTMFReferenceModelGoalsStandardcontentsIndustryopiniononwhatiskeptinaTMFStandardnamingBasedofftheICHE6Section8terminologyandindustryacceptedterminologyStandardstructureItdoesn’thavetobefolder-basedordepartmentalizedlikeinapapersystemStandardmetadataIfTMFisanEDMS,whatwouldbethebasics–atsystemandartifactlevel?1.5yearsofAccomplishmentsMar09InauguralmeetingandchartercreatedHowWorkontheModelisOrganized?11Zonesand222ArtifactsTrialManagementCentralTrialDocumentsRegulatoryIRB/IECandotherApprovalsSiteManagementIPandTrialSuppliesSafetyReportingCentralizedTestingThirdPartiesDataManagementStatisticsWho’sBeenInvolved?139membersonteam55%US,45%EU98CompaniesPharmaCROVendorRegulatoryagencyreviewMHRAFDATMFReferenceModelVersion1.0OverviewArtifactDefinitionCore/Recommended,ICH&EDMMetadataOverallModelUsingtheTMFReferenceModelforpaperFuturePlansLinkedingroup(TMFReferenceModel)ContinuedconnectionwithindustryrepresentativesCoordinatedfeedbackontheutilizationofthemodelbysponsors,CROs,andvendorsVersion1.1expectedbyDec2010/early2011TechnicalguidetothemodelVersion2.0ofmodelexpectedbyJune2011mayinclude:DeviceStudiesEarlyphasestudiesInvestigatorInitiatedStudiesRegionalexpansiveview
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