GCP培训专业知识讲座

GCPTrainingWhatcanwedotoensurehighdataquality?2023Jun1Pooq第1页GCP:StrivingforDataQuality第2页OverviewFarHighqualitydataLesstimeandeffort-----FewerqueriesNewtreatmentsLackPatientselectionSitemanagementProjectManagementDatamanagementFocusSite/PISelection;Training;ManagementExecutionMonitoringTopicsExperienceGoals第3页MonitorProblems

Monitor

traininginsufficiency

Monitor

NOTSiteManager

MonitorCommunicationSkillslack

Monitordifferentiate&Requirements

MVRtoosimple第4页PatientscometomajormedicalcentersfromsurroundingtownsandvillagesTripResultFindLostFu/WithdrawconsentDissatisfytreatmentTravelIssueRefusaltests

Fullyunderstandstudyrequirements

MeetTravelrequirements

CommittofullparticipationMedicalCare/InterventionNotAppropriatedHighRatesNon-ComplianceIssues…..Patientselection第5页

PotentialIndicationsFoundedPatientPopulationsComplywithProtocolWrittenICFparticipatedinStudyConfirmationSubjects第6页Protocol-specificeligibilitycriteria

FOLLOWprotocoldefinedfactorsErrorsCANNOTMONITORINGSiteEnrollmentPatientspopulationsdefinedClearlyOutcomeMeasuresrefineinstudyCallthestudystaffbeforerandomizationifIssueabouttheeligibilitycriteriaEligibilityrelatedtoDataIntegrity,Safety,EC,Scheduling,Cost..AnineligiblesubjectqualifiesasamajorprotocoldeviationAsubjectassignedwrongDevicecannotbechanged第7页Sitemanagement第8页

Challenges&MajorIssues(I):

SponsoroversightManagementinterfere;

InvestigatorlackinGCPknowledge&Agreementsense;

IECProceedingNOTReviewing;

ICNOTProcedure;

ProtocolNon-Compliance;

SourceDocumentDeficiency;

DatarevisionnotappropriateanddatedCause/Explain;

第9页

Challenges&MajorIssues(II):

InvestigationalMaterialsMisconduct;

OptionalNOTRandomizeSubject/replenishforWithdrawnsubjects;

NOClinicalOperationSOPOrNon-Compliance;

AEorSAEreportingNOTinclock;

DataNOTconsistencywithCRFandRADossier;

TMFISFarchivedelay;

CSRsubmissionMissed;

第10页11MonitoringVisitIntervals

Theabovemonitoringvisitintervalsaregivenasanexample.Actualmonitoringvisitinternalsshallbedefinedinthemonitoringplan.SDV:sourcedataverificationwillbeperformedaftersitepersonnelhastranscribeddataintoCRFMonitoringPeriodRecommendedTargetSiteInitiationVisitWithin1-2weekspriortofirstpatientvisit.1stMonitoringVisitAssoonaspractical,butnolaterthan2weeksafterthefirstpatientvisit.BetweenFirstandLastSubjectVisitEvery2weeks,includingonedosingdayandonepharmacokineticsamplingday.LastMonitoringVisitWithin2weeksafterthesite’slastsubjectvisitCloseoutVisitAfterresolutionofalldataqueriessenttothesite第11页12Pre-study

visitPre-studyPost-studyCloseout

visitMonitoringPlan2.MonitoringReports1.QueryLogStudyMonitoringProcessOutlineLivePhaseStudyPeriodScreeningStudyEntryFirstInterventionMultipleVisitCheckCheckFirstGivenPerformsourcedataverificationFollowUp

visit第12页

CRARoles

AssignedbySponsor;

Appropriatetraining

FamiliarwithCurrentRules,GCP&Regulations;

KnowledgeaboutIPPre-Clinical&Clinicalinformation;

SkilledintheProtocolProcedure&EssentialDocuments;

Communication&InterpersonalSkill

第13页

CRAResponsibility

BridgeLinkedInvestigatorandSponsor;

Qualification,Select,TrainInvestigator;

Pre-,During,AfterTrial,Visitsite&MeetStaffregularly(ProceedingasStudy,ICFed;RecordingCompleteness,CRFsourcing,Progress,AE,PD)

ReturnIP,TMF&ISFArchive

第14页●Sitetraining

●GCPverification

●SDV

●CRFsourcedoc

●SourcedocCRF

●BiggestissueinSomeTrials

第15页

Learnwhatyouneedtoknow

Meettheclinicians

Meetthesitestudystaff

CallthecliniciansWhatyouneedWhatYouNeed第16页MustFollowSOPsandMonitoringGuidelinesCompleteDocumentwhatwasdoneDocumentwhatwasopenfromlastvisitandstillremainsopenorifresolved,howresolvedRoutineMVReports第17页TrainingReal-timereviewofMVRIssueescalationSenseofurgencyandactionEstablishCAPAsDocumenteverythingWhatdidyouidentifytheissues?Whendidyouescalatetheissues?HowdoyouknowtheCAPAsareworking?HowtodealwithPD18第18页ClicktoedittitlestyleEfficacyAssessmentSafetyAssessment第19页Datamanagement第20页DataQuality-MonitoringObjectiveComplywithProtocol;Accuracywithrecordingretained;CompletenesswithSourcinglines;RightsSafetyWelfare-Subjectprotectivefromhurt;AccordingtoRules&Regulatories.第21页ReviewandsubmitReviewCheckthedataforCorrectnessCompletenessConsistencySubmitWhenyouaresatisfiedwiththecompleteness,correctnessandconsistencyofthedata第22页PlanbeforeyoustartIdentifycrucialdatafieldsWhowillberesponsibleforrecordingdataintheCRF?NurseFellowDatamanagerWhoresponsibleforcheckingthedatabeforesubmission?Whoisresponsibleforapprovingthesubmissionofdata?ThePrincipalInvestigatorisultimatelyresponsibleifthesiteisinspected第23页IdentifycrucialdatafieldsPrimaryendpointDoseDosemodificationreasonconsistentwithprotocolReasonfordiscontinuationconsistentwithprotocolAEsleadingtodosemodification/discontinuationproperlydocumentedManyhealthauthorityquestionsarisefromthesedata第24页DemographicsObviouserrorsHeightandweightthesameDiscontinuationdateReasonvsAEfieldsEfficacyForInvestigatorConfirmationMeasurementsEndPointConfirmationEffectiveAlldataavailablefordateIntegrityDeath第25页LookforobviousoddballsReconcileadverseeventdataUsequeriestoidentifyareasforimprovement第26页“Male”onoralcontraceptive“Female”onsildenafilGrade3alopeciaGrade2isbaldObviousmistakesPatientwhoweighs60kgandis60cmtallAlbumin=400第27页MustmakesensemedicallyReasonfordiscontinuationCauseofdeathAEsresultingindiscontinuation/death第28页HowtoqueryProvideenoughdetailstomakethequerybriefbutclear

BigreasonforopenqueriesisvaguequeriesAskforclinicalreviewofquery/response,ifnotcertainthatDCFshouldbeclosedExample:radiologistrefusedtoprovideRECISTmeasurementsInfact,patientwasallergictocontrast,makingaccuratemeasurementimpossible第29页EfficacyCompleteness