Real Time under an IDE - Food and Drug Administration：IDE -食品和药物管理局在的时间.ppt

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1、RealTimeunderanIDE–CDC’sPCRandELISAInvestigationalProtocolsRealTimeUnderanIDE:CDCSARSLaboratoryResponsePhaseI:AgentIdentificationPhaseII:AssayDevelopmentPhaseIII:AssayDeploymentCDCSARSLaboratoryResponse–PhaseI:March200312345678910111213141516171819202122232425262

2、728293031March14:OutbreakinvestigationorganizedMarch15-16-17:SamplesarrivedfromToronto,ThailandMarch18-22:Virusisolatedbycellculture,identifiedbyEMandIFAassayMarch23-24:VirusverifiedbyPCRandsequencing;prototypeELISAdevelopedCDCSARSLaboratoryResponse–PhaseII:April

3、2003123456789101112131415161718192021222324252627282930April3:Initiateddiscussionsfordevelopmentofreal-timePCRassaytobedeployedtoLRNlaboratoriesApril3–8:DiscussionswithFDAregardingfilingIDEforreal-timePCRassayApril7-18:AdditionalPCR“signatures”selectedandassayopt

4、imizedLRN“protocols”developed,written,approvedinternallyCDCSARSLaboratoryResponse–PhaseII:April2003123456789101112131415161718192021222324252627282930Synthesizeprimersandprobes,optimizeconditions,evaluateperformanceofassayLargescaleproductionprimersandprobes,disp

5、enseandlabel,QCforperformanceAlertLRNmembersofreagentsthatwillneedtobepurchasedApril21:LargescaleproductionEIAantigencompleteApril28:FDAdeterminesthatELISAassayis“lowrisk”;abbreviatedIDEappropriateIDEProcess–RealTimePCRPublishedreportsUnpublishedreportsInvestigat

6、ionalPlanPurposeProtocolRiskAnalysisDescriptionoftheDeviceMonitoringProceduresManufacturingInformationInvestigatorInformationIRBInformationLabelingInformedConsentMaterialsIRBDocumentationforRealTimePCRAssay–April30SARSCoronavirusPCRAssayProtocolAttachmentA-Publis

7、hedReportsAttachmentB-HealthcareprovidersinformationAttachmentC-InformedconsentAttachmentD1-SpecimenSubmissionFormAttachmentD2-SpecimenSubmissionForm-PlannedAmendmentsAttachmentE-ParticipantInformationSheetAttachmentF-LaboratoryResponseNetwork(LRN)ProcedureCovers

8、heetAttachmentF1-F3-LaboratoryResponseNetwork(LRN)“Protocols”AttachmentG-SARSAssayHistoryAttachmentH-PrimersandProbesPackageInformationAttachmentI-SARSPrimersa