OverviewFDAsBioresearchMonitoringProgramPreparationforResponseExamplesViolationsOverviewFDAsProgramProgramsprotectrightssafetywelfareinvolvedFDAregulatedclinicalverifyaccuracyreliabilityclinicaldatasu ID: 866908
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1 J.D.AssociateChancellor,FDA Inspections:
J.D.AssociateChancellor,FDA Inspections: OverviewFDAsBioresearchMonitoringProgramPreparationforResponseExamplesViolations OverviewFDAsPr
2 ogram Programsprotectrights,safety,welf
ogram Programsprotectrights,safety,welfareinvolvedFDAregulatedclinicalverifyaccuracyreliabilityclinicaldatasubmittedFDAresearchmarketingapp
3 lications;complianceFDA'sregulationsgove
lications;complianceFDA'sregulationsgoverningconductclinical ProgramsFocus*mayroutineforcause.verifyingaccuracyreliabilitydata,mayconduct
4 ed:resultcomplaintconcernterminationclin
ed:resultcomplaintconcernterminationclinicalsiteproviderealassessmentongoingrequestFDAreviewPerFDAsworkfortargetedhttp://www.fda.gov/downlo
5 ads/RegulatoryInformation/Guidances/UCM1
ads/RegulatoryInformation/Guidances/UCM126 likelihoodmayincreaseEnrollmentlastProtocolviolationsAdverseEventsdeathsstudiessite/PI (FDAMetric
6 sFY14) Preparationfor WhatBeforeStartCo
sFY14) Preparationfor WhatBeforeStartContactFDA,notifydesignatedresearchadministrationofficeKUMCRIKUCC,sponsor.FDAChecklist.FDAinvestigator
7 expectrecordsavailableorganized.Identify
expectrecordsavailableorganized.Identifyappropriateroomcopier WhatBeforeStartDeterminedesignatedescort.personkeepquestionsaskeddocumentsrequ
8 ested.availablethroughout.Determineprese
ested.availablethroughout.Determinepresentstartmeeting.arrival,FDAinvestigatorpresentFormFDA Conduct answeringquestions:clear,concise,polite
9 honestvolunteerinformationyouanswer,writ
honestvolunteerinformationyouanswer,writequestionreferquestionappropriateargueFDAInvestigator FDAInvestigatorReview:Regulatorydocuments,prot
10 ocol,enrollmentDatesapprovals,screening,
ocol,enrollmentDatesapprovals,screening,consenting,firstadministrationinvestigationalproduct,etc.CRFssourcedocumentationConsentformsIntervi
11 ewstaff FDAinvestigatorConfirm:Whetherre
ewstaff FDAinvestigatorConfirm:Whetherreviewwasobtained(protocol,ICFs,amendments)WherestudywereperformedWhetherinclusion/exclusioncriteriaw
12 eremetWhetherinformedconsentwasobtainedp
eremetWhetherinformedconsentwasobtainedperformancestudyrelatedprocedures FDAInvestigatorEvaluate:Whetherprotocolwasfollowedwhetherprotocolde
13 viationsweredocumentedreportedWhethercon
viationsweredocumentedreportedWhetherconductstudywasdelegatednatureclinicalinvestigatoroversightWhetheradverseexperienceswereproperlyreporte
14 d FDAInvestigatorEvaluate:Whethersourced
d FDAInvestigatorEvaluate:WhethersourcedocumentationmatchesCRFs,(whereapplicable)whetherdatasubmittedmatchesCRFs/sourcedocumentsWhetherdocu
15 mentationinvestigationalproductaccountab
mentationinvestigationalproductaccountabilitycomplete(receipt,storage,return) FDAInvestigatorconductexitinterviewdeficienciesarefound,writte
16 nFormFDADocumentobservations,comments,et
nFormFDADocumentobservations,comments,etc.Determinedesignatedresearchadministrationofficepresentforexitinterview.designatedHRPP/Officecontac
17 t. Response ResponseFormFDADeficiencies/
t. Response ResponseFormFDADeficiencies/deviationsfromregulationsareidentifiedFormFDAFormFDAmustprovidedHRPP.writtenresponserequired,encoura
18 ged.ContactOfficeforbestpracticeinformat
ged.ContactOfficeforbestpracticeinformation.Generally, EstablishmentReportEstablishmentReportsent,collectedmaterialsinvestigatorsresponseFD
19 ACenterforevaluationclassification:indic
ACenterforevaluationclassification:indicatedVoluntaryIndicated(VAI)OfficialIndicated(OAI) FDALetterClinicalInvestigatorAfterreviewclassifica
20 tionlettersentclinicalinvestigator.  Â
tionlettersentclinicalinvestigator.   couldletterobservingcompliancepertinentregulationsInformationalUntitledLetterWarningLetterInitiatio
21 nDisqualificationProceedings Classificat
nDisqualificationProceedings Classifications(FDAMetricsFY14) ExamplesViolations ExamplesViolationsconsentdocumentsrequiredelementsobtaining
22 consentRecordsfailureappropriatelydelega
consentRecordsfailureappropriatelydelegatepersonnel(e.g.,physicalexams,SAEevaluations),resultingexposureunreasonablesignificantinjury,unreli
23 abilitydata ExamplesViolationsCRFsforstu
abilitydata ExamplesViolationsCRFsforstudyexistparticipatestudyFalsifiedconsents(signaturesmatch)CRFsresultsprotocolrequiredproceduresdocume
24 ntationthattheywereand/orresultscharacte
ntationthattheywereand/orresultscharacterizedfromthatwere ExamplesViolationsEnrollingmeetentrancecriteriaAdministrationtestpersonsauthorized
25 receiveFailureperformprotocolrequiredpro
receiveFailureperformprotocolrequiredproceduresdocumentationrequiredreviewstudychanges ExamplesViolationsdocumentationcontinuingreviewIncomp
26 leterecords,e.g.,evidencerecordsdiscarde
leterecords,e.g.,evidencerecordsdiscardeddestroyedinvestigationalproductunauthorizedinadequaterecordsre:receipt,preparation,returninvestigat
27 ionalproduct MostDeficienciesFailurefoll
ionalproduct MostDeficienciesFailurefollowinvestigationaland/orregulationsProtocoldeviationsInadequaterecordkeepingInadequateaccountabilityf
28 orinvestigationalproductInadequatecommun
orinvestigationalproductInadequatecommunicationInadequateprotectionfailurereportinformedconsent FDAClinicalInvestigators,U.S.Dept.Servicesh
29 ttp://www.fda.gov/downloads/RegulatoryIn
ttp://www.fda.gov/downloads/RegulatoryInformation/Guid FDAProgramClinicalInvestigatorsInvestigators,ProgramForinvestigators,FDAProgramSponso
30 rs,ContractResearchOrganizationsMonitors
rs,ContractResearchOrganizationsMonitors,Program(MarchforClinicalPractice KUMCResourcesKUMCResearchInstituteCenterKUMCChecklistKUMCResearchP