水利水电行业计量认证检测参数常用标

TipologiediAuditelorocaratteristicheRiunionesottogruppoGCP-GIQAR21Marzo2006FrancescaBucchi喷灌机

PROCEDURES1

-PreparingfortheAudit2-ConductingtheAudit3-ReportingtheAudit

15workingdaysDraftReportIssued

15workingdaysResponsesProvided

ResponsesReviewed/AcceptedFinalReportIssuedResponsibilitiesLeadAuditor:Willfacilitateorganising,conductingandreportingoftheaudit.He/shewillleadtheauditactivitiesandwillpreparetheauditreportPSA(ProjectSpecificAuditor)InlinewithLineManagementisresponsiblefor:-Developmentoftheauditprogramme-Beingthefocalpointofcontactwiththeclinicalteamsforaudits-EnsuringthatauditorsconductingauditsareawareofprojectrelatedauditissuesResponsibilities(cont’d)ProcessOwner:He/sheisresponsibleforHarmonisationofalloperationalactivitiesoftheprocess,includingitsdevelopmentandimprovementSYSTEMSAUDITSWhatareGlobalSystemsAudits?

Asystemsauditisareviewoftheorganisation,proceduresanddocumentationrelatedtoaselectedsystem,oranexaminationofaprocessorgroupofprocessesthatresultinanendproduct.Whya“systems〞approach?AllworkisprocessdrivenandthesystemsapproachfocusesonauditingtheprocessItcanactaskeyfactfindingtoolforprocessimprovementItcanprovideanevaluationofinterfaceswithinSponsor,andbetweenSponsorandpreferredprovidersItcanassessofcross-functionalconsistencyinaglobalorganisationSomeofthekeyareasforwhichasystemsapproachwouldbeadoptedinclude:ProcessManagementandTrainingTrialManagementMonitoringDataManagementSafetyManagementInvestigationalProduct(IP)ManagementArchivingofEssentialDocumentsComputerisedsystemsHowaretheyperformed?

Systemsauditsmayconsistofvisit-basedauditscoveringanumberoflocationsordesk-basedfromtheCQAoffices.

Theauditsmaybeconductedasacombinationofdocumentationreview,questionnairesand/orInterviewAuditProcedurePreparationAssignAuditTeamIdentifyAuditSponsor(global/local)DefinescopeoftheauditDefineauditreferencesandstandardsDevelopauditplan&tools(e.g.auditmethodquestionnaires,checklists,agenda)IdentifyauditsampleNotification–earlyenoughtoensurethatpersonnelinvolvedareavailableRequestfordocumentationAuditProcedure(cont’d)ConductingtheAuditAuditmayinvolvevisitstooneormore

SponsorsitesormaybeconductedviatelephonediscussionsandreviewofdocumentsonlyDuration–between2and4dayspersiteBalancebetweendiscussions,reviewofdocumentsandreviewoffacilitiesDiscussions–encouragingstafftoexplaintheirdailywork,understandingtheissue&rootcauseFocusisnotontheindividualReviewofdocuments–e.g.procedures,trainingrecords,CVs,jobdescriptions,documentsrelatedtothesystemauditedReviewoffacilities–e.g.archiveAuditProcedure(cont’d)ReportingandFollow-upInitialfeedbackattheendoftheauditDraftauditreportissuedtoAuditSponsorforrespondingFinalreportincludesresponsesandactionsAuditSponsorresponsibleforfollow-upauditfindingsInvestigatorSiteAuditsABCHOSPITALWhyInvestigatorSites?ObligationtoensurethatstudiesareconductedtotherelevantnationalandinternationallawsObligationtoensurethatstudiesareconductedtoGCPAssurancethatthecompanyandinvestigatorsiteswouldstanduptoaregulatoryinspectionWhichstudies?regulatorysubmissionstatuspriority

oftheprojectinR&Dportfoliopivotal

statusofstudyWhichcentres?1-15%InvestigatorSiteAuditsInvestigatorSiteAuditsSelectionofinvestigatorsitesisbasedon:RecruitmentSiteworkloadSitewithnewinvestigator,monitoringstafforusingnewsystemsCoordinatinginvestigatorsitesRequestsfromstudyteams/complianceconcerns(“Forcause〞)Howaretheyperformed?Examinationof3basicaspectsNatureoftheinvestigator’sconductofthestudyThe

interaction

betweenthemonitorandtheinvestigatorPatientsourcedata

thatsupportsentriesontheCRFIn2stepsAtmonitor’sofficeAtstudysiteInvestigatorSiteAuditsWhathappensattheinvestigatorsite?OPENINGMEETINGIntroductionsObjectivesAuditprocedureInvestigatorinterviewRoleofstaffINVESTIGATORFILEAUDITSOURCEDATAVERIFICATIONDRUGSTORAGE/DISPENSINGACCOUNTABILITYEXITMEETINGVerbalfeedback-keyauditobservationsClarifyanyoutstandingissuesAuditornotesinvestigator’scommentsThanksitestaffTOUROFSTUDYRELATEDFACILITIES/EQUIPMENTDOCUMENTAUDITSScopeofDocumentAuditsThedocumentauditsreferbutarenotlimitedto:HighLevelDocuments(HLDs)(integratedsummaryofdataacrossstudiesforaparticularsectionofaregulatorysubmission)Investigator’sBrochures(IBs)ClinicalStudyProtocols(CSPs)ClinicalStudyReports(CSRs)Thequalityofthedocumentisassessedforinternalconsistencyandagainstappropriatesourcedocuments,furthertoGCPandapplicableregulatoryrequirementsHowaretheyperformed?ReviewagainstrelevantclinicalSOPs,guidelines,templates,etc.CheckforcompletenessandlogicAreviewofthetextforaccuracyandconsistencyAreviewagainstthesourceDATABASEAUDITSSCOPEItislimitedtotheinformationintheclinicalstudydatabaseandthesupportingdocumentationfortheprocessfromdatabasesetuptocleanfileTheauditofonedatabaseisdividedintoblocksandmaybestagedovertimePROCEDUREAuditStructureItwillbeconductedin3blocks:ToverifypresenceandapprovalofaselectionofDMdocumentationforthestudyToverifydatawithcleandatastatusfromdataentrysiteToverifydatathathavecompletedcentralvalidationandtoverifyselectedDMdocumentationPROCEDUREElectronicDataCaptureForstudiesusingWebBasedDataCapturetheprocedurewillbea