process chart - med...2018/05/18 · risk and contingency plan understand real needs clarify what...
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Copyright:臨床研究の品質向上ツール作成WG&日本医師会,2018Allrightsreserved
PROCESSCHART臨床研究の品質向上ツール作成WG
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Copyright:臨床研究の品質向上ツール作成WG&日本医師会,2018Allrightsreserved
本研究の⽬的• 現時点において品質管理システムあるいは品質管理計画に基づく、Goal志向のデザインアプローチとなるQualitybyDesign(QbD)において、プロトコルに必須の領域あるいは実臨床に関連する領域での品質管理指標として、何を基準にどのように推奨するかについて、まだ汎⽤的なツールがないのが現状である。• 本研究では、被験者保護、データの質確保を⽬標として、QbDによる実施計画書の作成に必要なツールを検討及び作成し臨床研究の品質向上を⽬指す。
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Copyright:臨床研究の品質向上ツール作成WG&日本医師会,2018Allrightsreserved
本研究で整備⽬標としたQbDツール
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QbD概念に対する教育コン
テンツ
QbDによるプロトコル開発
プロセスチャート
品質管理項⽬を組み込んだ実施計画書
フローチャート提⽰PPT提⽰
次期活動で検討(H30年度)
Copyright:臨床研究の品質向上ツール作成WG&日本医師会,2018Allrightsreserved
WholeProcessofQbDprotocolplanning
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ClinicalQuestionDrugSeeds
ResearchQuestionTPP/CDP
SynopsisProjectCharter
Protocoldraft
QMplanPMplan
ProtocolRMP
SpecificationofClinicalQuestionResearchyourtopicStructureofPICO/PECOBrushupusingFINERmethod
MissionProfiling(TPP/CDP)SetupthegoaloftheStudyProtocolSynopsisConsiderationofProjectScope,Time,CostMakeProjectCharter
QualitymanagementplanSynopsisbrushupDraftcostestimationRiskmanagementandMitigationplanFinalizeProjectmanagementplan
ProtocolfeasibilityassessmentDetailscostestimationConstructionofdraftRMPFinalizationofProtocolFinalizationofRMP
InvestigateRQs ProjectDesign QualitybyDesign FeasibilityAssessment
ScientificOutcome
ManagementOutcome
*
*:TPP:TargetProductProfile,CDP:ClinicalDevelopmentPlan,QM:QualityManagement,PM:ProjectManagement,RMP:Risk-basedMonitoringPlan
Copyright:臨床研究の品質向上ツール作成WG&日本医師会,2018Allrightsreserved
INVESTIGATERQS
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Copyright:臨床研究の品質向上ツール作成WG&日本医師会,2018Allrightsreserved
WholeProcessofQbDprotocolplanning
18/03/31 ProcessChart_臨床研究の品質向上ツール作成WG 6
ClinicalQuestionDrugSeeds
ResearchQuestionTPP/CDP
SynopsisProjectCharter
Protocoldraft
QMplanPMplan
ProtocolRMP
SpecificationofClinicalQuestionResearchyourtopicStructureofPICO/PECOBrushupusingFINERmethod
MissionProfiling(TPP/CDP)SetupthegoaloftheStudyProtocolSynopsisConsiderationofProjectScope,Time,CostMakeProjectCharter
QualitymanagementplanSynopsisbrushupDraftcostestimationRiskmanagementandMitigationplanFinalizeProjectmanagementplan
ProtocolfeasibilityassessmentDetailscostestimationConstructionofdraftRMPFinalizationofProtocolFinalizationofRMP
InvestigateRQs ProjectDesign QualitybyDesign FeasibilityAssessment
Copyright:臨床研究の品質向上ツール作成WG&日本医師会,2018Allrightsreserved
InvestigateResearchQuestions
SpecificationofClinicalQuestion
Researchyourtopic
StructureofPICO/PECO
BrushupusingFINERmethod
7
ClinicalQuestion
ResearchQuestion
Output
input
18/03/31 ProcessChart_臨床研究の品質向上ツール作成WG
Copyright:臨床研究の品質向上ツール作成WG&日本医師会,2018Allrightsreserved
SpecificationofClinicalQuestion
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Input Process Output
ClinicalQuestion Wants/Needsspecification ResearchTopic
• clinicalquestionfrombedside
• Realunmetneeds• Clinicalwants• Stateoftheart• ClinicalGuideline• Casereport• EHRdata• Reputationsurvey
• Researchhypothesis• Thesaurus• Searchword
Copyright:臨床研究の品質向上ツール作成WG&日本医師会,2018Allrightsreserved
Researchyourtopic
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Input Process Output
ResearchTopic Literaturereview ClinicalQuestion(detail)
• Researchhypothesis• Thesaurus• Searchword
• Clinicalguideline• Pubmed• MEDLINE• CochraneDatabase/SystematicReview• Scopus• GoogleScholar• Criticalappraisalofselectedpapers
• Researchhypothesis(detail)• ClinicalQuestion(detail)
Copyright:臨床研究の品質向上ツール作成WG&日本医師会,2018Allrightsreserved
StructureofPICO/PECO
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Input Process Output
ClinicalQuestion(Detail)
SpecificationofPICO/PECO
ResearchQuestions(draft)
ConsiderStudyDesign
• Researchhypothesis(detail)• ClinicalQuestion(detail)• Compound
• PICO/PECOP(Patient)I(Intervention)/E(Exposure)C(Comparison)O(Objective)• StudyDesign(draft)
• ResearchQuestions(draft)• TrialGoal(draft)• Researchbenchmark
DrugSeeds
Copyright:臨床研究の品質向上ツール作成WG&日本医師会,2018Allrightsreserved
RQsbrushupusingFINERmethod
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Input Process Output
ResearchQuestions(draft)
ResearchQuestions(RQs)
EvaluateRQsbasedonFINER
• ResearchQuestions(draft)• TrialGoal(draft)• Researchbenchmark
• FINERevaluationF:FeasibleI:InterestN:NovelE:EthicalR:Relevant
• ResearchQuestionsTrialGoal(draft)• Researchbenchmark
Copyright:臨床研究の品質向上ツール作成WG&日本医師会,2018Allrightsreserved
PROJECTDESIGN
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Copyright:臨床研究の品質向上ツール作成WG&日本医師会,2018Allrightsreserved
WholeProcessofQbDprotocolplanning
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ClinicalQuestionDrugSeeds
ResearchQuestionTPP/CDP
SynopsisProjectCharter
Protocoldraft
QMplanPMplan
ProtocolRMP
SpecificationofClinicalQuestionResearchyourtopicStructureofPICO/PECOBrushupusingFINERmethod
MissionProfiling(TPP/CDP)SetupthegoaloftheStudyProtocolSynopsisConsiderationofProjectScope,Time,CostMakeProjectCharter
QualitymanagementplanSynopsisbrushupDraftcostestimationRiskmanagementandMitigationplanFinalizeProjectmanagementplan
ProtocolfeasibilityassessmentDetailscostestimationConstructionofdraftRMPFinalizationofProtocolFinalizationofRMP
InvestigateRQs ProjectDesign QualitybyDesign FeasibilityAssessment
Copyright:臨床研究の品質向上ツール作成WG&日本医師会,2018Allrightsreserved
ProjectDesign
MissionProfiling(TPP/CDP)
SetupthegoaloftheStudy
ProtocolSynopsis
ConsiderationofProjectScope,Time,Cost
MakeProjectCharter
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ResearchQuestion
SynopsisProjectChater
Output
input
18/03/31 ProcessChart_臨床研究の品質向上ツール作成WG
Copyright:臨床研究の品質向上ツール作成WG&日本医師会,2018Allrightsreserved
MissionProfiling
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Input Process Output
DrugSeeds
CompoundPatentHealthcareenvironmentHypothesisoftheStudyP:PatientI/E:Intervention/ExposureC:ComparisonO:Outcome
Efficacy/SafetybenchmarkDrugProductDosingRegimenPatentScientificInterestNoveltySocialImpactMedicalRealNeedsPositioninginthemedicalfieldCompetingproductResearchRegulatoryResearchMarketingResearchRiskassessmentDefineCriteriaforGo/Nogo
IdentifyTargetProductProfile
Environmentalfactor
ClinicalDevelopmentPlan(Draft)
ResearchQuestion(RQ)
MissionProfiling
TPPPositioningCompetingproductDevelopmentStrategyRegulatoryStrategyMarketingStrategyPatentInformationDecision-makingapproachRiskestimation
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MissionProfiling(contd.)
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Asis
Tobe
ResearchQuestionProjectValue
Intangiblevalue
Gapanalysis
CDP
Tangiblevalue
StudyGoal
FINER Relevant
NewTreatment
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MissionProfiling 概念図
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現状
実⾏シナリオ
課題①
課題②
課題③
プロジェクト①
プロジェクト②
プロジェクト③
現状を正しく理解する ⽬指す状態
ギャップを理解し、プロジェクトを定義、シナリオを作り実⾏する
関係性分析課題の明確化プロジェクトの検討体制の検討
ミッション表現成果物の価値を表現シナリオ展開
実⾏性を検証しシナリオを作成
到達レベル
時間
開発シーズ医療ニーズ
新しい医療の提供
CDPTrialPlan
ThegoalofStudy
特許
安全性
薬事規制
TPPTrialProfile
プログラム
Copyright:臨床研究の品質向上ツール作成WG&日本医師会,2018Allrightsreserved
SetupthegoaloftheStudy
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Input Process Output
ClinicalDevelopmentPlan(Draft)Environmental
factorTPPFinancialplanResourceplanDevelopmentScheduleStudyplanThegoalofthestudyStudyDurationDefinitepositioningQualityPolicyRegulatoryStrategyMarketingStrategyPatentInformationDecision-makingapproachRiskandContingencyplan
UnderstandRealNeeds
Clarifywhattoverify
FeasibilityEthicalityMedicalRealNeedsStudyGoalQualityGoalPositioninginthemedicalfieldEstimatecostEstimateResourceEstimatescheduleWhattoverifyAppropriatePICO/PECO
TPPPositioningCompetingproductDevelopmentStrategyRegulatoryStrategyPatentInformationDecision-makingapproachRiskestimationFinancialrequirementsResourcerequirementsDevelopmentScheduleNumberofPatient
Setupthegoalofstudy
EstimateCost,Resource,Schedule
ClinicalDevelopmentPlan
Copyright:臨床研究の品質向上ツール作成WG&日本医師会,2018Allrightsreserved
TargetProductProfile(TPP)• TPP:承認申請に必要な開発プログラム全体の意図が記載され、その時点での適切な情報が記載されているもの。開発のゴールが明記されている。(2007年3⽉FDAガイダンス)
• TPPに記載すべき項⽬(例)• 製品の概要• 疾患セグメント• Keyとなる項⽬• 有効性:有効性のベンチマーク、Go/Nogoの判断基準• 安全性:安全性のベンチマーク、Go/Nogoの判断基準• 製剤:規格・安定性や扱いやすさ(保管条件)• 投与計画:経路・⽤法⽤量
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ClinicalDevelopmentPlan(CDP)• 臨床開発計画(ClinicalDevelopmentPlan、CDP)• どのようなターゲットに対して、どういう試験を実施するかにつ
いてまとめたもの
• CDPの項⽬の例• 開発の経緯• 薬効・薬理の概略• 臨床的な位置づけ• 類薬の開発状況• ⽤量探索・有効性及び安全性評価計画(I相〜III相、⻑期試験等)• リスクとその対応策• ⼈員、資⾦計画• タイムスケジュール• 意思決定⽅法
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ProtocolSynopsis
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Input Process Output
ThegoaloftheStudy
ConsidertheStudyDesign
ProtocolSynopsis
Determinethestudysubject
StudyrealObjectiveStudyDurationAppropriatePICO/PECOP:PatientI/E:Intervention/ExposureC:ComparisonO:OutcomeDefinitepositioningWhattoverifyQualityPolicy
StudyObjectiveTargetSubjectInclusionCriteriaExclusionCriteriaStudyDesignEndpointComparativeControlledTherapyTargetnumberofsubjectsStatisticalAnalysis
QualitygoalTargetSubjectCriteriaNumberofSubjectComparisonEndpointAnalyticalmethodofendpointStudyMethodInvestigationItem
DetermineQualitygoal
Designthenumberofsubject
ObjectifyRQClarifyRQ
ClinicalDevelopmentPlan
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ConsiderationofProjectScope,Time,Cost
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Input Process Output
ProtocolSynopsis
EstimatetheprojectSchedule
Estimatetheprojectcost
DefinitetheQualitygoal
StudyObjectiveStudySubjectInclusionCriteriaExclusionCriteriaStudyDesignEndpointComparativeControlledTherapyTargetnumberofsubjectsStatisticalAnalysisPastCasesOrganizationalKnowledge
StudyScheduleRequisiteDurationtoconductstudyRequisiteQualitygoalRequisitecostRequisiteResourceRegulatoryRequirement
EstimateResource
ProjectCharter
(Draft)
ProjectObjectiveQualitygoalProjectDurationProjectCostDeliverableStudyOrganizationStudyMethod
DeterminetheDeliverable
Referpastcases
OrganizationalKnowledge
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MakeProjectCharter
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Input Process Output
ProjectCharter
(Draft)DecidePriorityofProject
Scope,Time,Cost ProjectCharter
AssesstheProjectRisk
IdentifytheStakeholder
ProjectObjectiveQualitygoalProjectDurationProjectCostDeliverableStudyOrganizationStudyMethodSummaryofStudy
ProjectObjectiveProjectGoalProjectRiskMilestoneScheduleBudgetaryEstimateStakeholderProjectExitcriteriaProjectsuccesscriteriaProjectDurationAssumptionConstraintProjectRequirement(Scope)
Priority(Quality(Scope),Time,Cost)ProjectRiskRegulatoryRequirementOrganizationalneedsCustomerRequestQualitygoalProjectmemberProjectResource
AssesstheStudycircumstance
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QUALITYBYDESIGN
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Copyright:臨床研究の品質向上ツール作成WG&日本医師会,2018Allrightsreserved
WholeProcessofQbDprotocolplanning
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ClinicalQuestionDrugSeeds
ResearchQuestionTPP/CDP
SynopsisProjectCharter
Protocoldraft
QMplanPMplan
ProtocolRMP
SpecificationofClinicalQuestionResearchyourtopicStructureofPICO/PECOBrushupusingFINERmethod
MissionProfiling(TPP/CDP)SetupthegoaloftheStudyProtocolSynopsisConsiderationofProjectScope,Time,CostMakeProjectCharter
QualitymanagementplanSynopsisbrushupDraftcostestimationRiskmanagementandMitigationplanFinalizeProjectmanagementplan
ProtocolfeasibilityassessmentDetailscostestimationConstructionofdraftRMPFinalizationofProtocolFinalizationofRMP
InvestigateRQs ProjectDesign QualitybyDesign FeasibilityAssessment
Copyright:臨床研究の品質向上ツール作成WG&日本医師会,2018Allrightsreserved
QualitybyDesign
Qualitymanagementplan
Synopsisbrushup
Draftcostestimation
RiskmanagementandMitigationplan
FinalizeProjectmanagementplan
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SynopsisProjectChater
ProtocoldraftQMplanPMplan
input
Output
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Copyright:臨床研究の品質向上ツール作成WG&日本医師会,2018Allrightsreserved
Qualitymanagementplan
18/03/31 ProcessChart_臨床研究の品質向上ツール作成WG 27
Input Process Output
ProjectCharterIdentifytheProjectRisk
QualityManagementPlan
Definethequalitypolicies,measurements
ProjectObjectiveProjectGoalProjectRiskMilestoneScheduleBudgetaryEstimateStakeholderProjectExitcriteriaProjectsuccesscriteriaProjectDurationAssumptionConstraintProjectRequirement
1.Qualitypolicyofthetrial2.Requirementsofthetrial(customer,lawsandregulations,implementationsystem)3.Scopeandauthority4.Riskidentificationandriskmanagementplan5.Qualitymanagementplan6.Qualitymanagement(monitoringmethods,monitoringmethods)7.Qualityassurance(thepresenceorabsenceofaudit,systemoftheaudit)8.Changemanagement9.Educationandtraining
ClarifythegoaloftheclinicaltrialDefinethequalitypolicyDefinethequalityobjectivesRiskassessment
ProtocolSynopsis
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QualityManagementPlanp Clarifythegoaloftheclinicaltrialp Definethequalitypolicyp Definethequalityobjectivesp Riskassessment
QualityManagementPlan
TrialProtocol
SOPs,WorkingInstruction
manuals
Preparationforthequalitymanagementplan
Preparationfortheoperatingprocedureorinstructionsfortrial
monitoringandauditing
Planningtheprotocolwell-behavedfromthequalitymanagementplan
• QualityManagementSystem(SOPs,Computerizedsystems,humanresources,outsourcing,infrastructure)
• Clinicaltrialprotocol (investigationalnewdrugs,trialdesign,datacollectingprocess,monitoringprocess,documentsorrecords)
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Copyright:臨床研究の品質向上ツール作成WG&日本医師会,2018Allrightsreserved
Synopsisbrushup
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Input Process Output
ProtocolSynopsis Protocoldraft
StudyObjectiveTargetSubjectInclusionCriteriaExclusionCriteriaStudyDesignEndpointComparativeControlledTherapyTargetnumberofsubjectsStatisticalAnalysisIndicationStudyDurationQualityrequirementTrialtimeline
QualitygoalTargetSubjectCriteriaNumberofSubjectComparisonEndpointAnalyticalmethodofendpointStudyMethodInvestigationItem
StudyObjectiveTargetSubjectInclusionCriteriaExclusionCriteriaStudyDesignEndpointComparativeControlledTherapyTargetnumberofsubjectsStatisticalAnalysis
ConsidertheQMP
Determinethestudyoutcome
DetermineTrialTimeline
ConsiderthepolicyofRiskManagement
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Draftcostestimation
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Input Process Output
ProtocolDraft ConsiderProtocoldraft
ProjectCostPlan
ProjectObjectiveQualitygoalProjectDurationProjectCostDeliverableStudyOrganizationStudyMethod
ProjectObjectiveQualitygoalProjectDurationProjectCostDeliverableStudyOrganizationStudyMethod
Considerprotocoldraft,includingtimeline,outcomes,qualitygoals,duration,studyresourceCostestimationQualityrequirements
Estimatetheprojectcost
EstimateResource
DeterminetheDeliverable
Referpastcases
ProjectCharter
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RiskManagementandMitigationplan
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Input Process Output
QualityManagementPlan ConsiderRiskand
AssessmentRiskManagementandMitigationPlan
ConsiderCAPAplan
ConsiderRiskMitigationPlan
1. RiskManagement2. RiskQuantitative
Analysis3. RiskQualitative
Analysis4. RiskMitigation
plan5. RiskControl6. CAPAplan
ConsiderRiskManagementplanIdentifyRiskRiskanalysis:QuantitativeandQualitativeanalysisConsiderRiskMitigationandRiskControlConsiderCAPAplan
1.Qualitypolicyofthetrial2.Requirementsofthetrial(customer,lawsandregulations,implementationsystem)3.Scopeandauthority4.Riskidentificationandriskmanagementplan5.Qualitymanagementplan6.Qualitymanagement(monitoringmethods,monitoringmethods)7.Qualityassurance(thepresenceorabsenceofaudit,systemoftheaudit)8.Changemanagement9.Educationandtraining
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FinalizeProjectmanagementplan
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Input Process Output
RiskManagementandMitigationPlan
DefineProjectActivity
ProjectManagementPlan
ConsiderRiskManagement
plan
Considerresource,cost,
duration,stakeholders
ProjectObjectiveQualitygoalProjectDurationProjectCostDeliverableStudyOrganizationStudyMethod
1.ScopeManagement2.ProjectRequirements3.ScheduleManagement4.CostManagement5.QualityManagement6.ResourceManagement7.CommunicationManagement8.RiskManagement9.ProcureManagement10.StakeholderEngagement11.ChangeManagement12.ConfigurationManagement13.Scopebaseline14.Schedulebaseline15.Costbaseline16.Performancebaseline17.ProjectLifecycle18.DevelopmentMethod
CorrectiveandPreventiveActionConsiderQualityManagementplanDefineprojectactivityandscopeDefineprojectdevelopmentandchangemanagementmethodConsiderRiskManagementplanConsiderProtocolDraft
ProjectCostPlan
QualityManagementPlan
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FEASIBILITYASSESSMENT
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Copyright:臨床研究の品質向上ツール作成WG&日本医師会,2018Allrightsreserved
WholeProcessofQbDprotocolplanning
18/03/31 ProcessChart_臨床研究の品質向上ツール作成WG 34
ClinicalQuestionDrugSeeds
ResearchQuestionTPP/CDP
SynopsisProjectCharter
Protocoldraft
QMplanPMplan
ProtocolRMP
SpecificationofClinicalQuestionResearchyourtopicStructureofPICO/PECOBrushupusingFINERmethod
MissionProfiling(TPP/CDP)SetupthegoaloftheStudyProtocolSynopsisConsiderationofProjectScope,Time,CostMakeProjectCharter
QualitymanagementplanSynopsisbrushupDraftcostestimationRiskmanagementandMitigationplanFinalizeProjectmanagementplan
ProtocolfeasibilityassessmentDetailscostestimationConstructionofdraftRMPFinalizationofProtocolFinalizationofRMP
InvestigateRQs ProjectDesign QualitybyDesign FeasibilityAssessment
Copyright:臨床研究の品質向上ツール作成WG&日本医師会,2018Allrightsreserved
FeasibilityAssessment
Protocolfeasibilityassessment
Detailscostestimation
ConstructionofdraftRMP
FinalizationofProtocol
FinalizationofRMPProtocolRMP
ProtocoldraftQMplanPMplan
input
Output
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Copyright:臨床研究の品質向上ツール作成WG&日本医師会,2018Allrightsreserved
Protocolfeasibilityassessment
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Input Process Output
Protocoldraft Reviewprotocoldraft
Protocolfinaldraft
IdentifycandidatesitesPMplan
QMplanDesignPatientpopulationIndicationI/EcriteriaSamplesizeEndpointsDurationQualityrequirementTrialtimeline
KeyRoleIntroductionObjectiveStudyDesign,EndpointsEnrollmentInvestigationaldrugStudyProcedureStudyScheduleAssessmentofSafetyClinicalMonitoringStatisticalConsiderationsSDV,SourceDataEthicsDataHandlingStudyadministrationCOI,Publication
EnsureclinicalfeasibilityEnsurescientificfeasibilityEnsureethicalfeasibilityEnsureoperationalfeasibilityEnsureregulatoryfeasibilityEnsurelegalfeasibilityDiscusswithPIs,Regulatory
DiscusswithPIs,regulatory
Identifydifficulty
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Detailscostestimation
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Input Process Output
Protocolfinaldraft
Sharewithvendors
Finalcostestimation
Obtainestimatefromvendors
PMplanQMplanDesignTimelineSamplesizeTrialorganizationRegulatoryrequirementProtocolrequirementQualityrequirementCriticaltoQuality(CTQ)Riskmitigationplan
Discussaboutresource(people,materials,cost)ShareprotocolwithvendorsCollectallcostestimationsEstimatedirect,passthrough,fixesandvariablecost
Estimateperpatientcost
Estimatedirectcost
DirectcostPassthroughcostFixescostVariablecostSitecostVendor(EDC/CRF,IXRS,Centrallab,CRO,SMO,Medicalwriting,DM/Stat,Audit)cost
ProjectManagementPlan
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ConstructionofdraftRMP
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Input Process Output
Protocolfinaldraft
Discussmonitoringplan
DiscussPMplan
PMplanQMplanEndpointsCandidatepatientsBudgetestimateTrialcostTrialorganizationTrialcomplexityPotentialriskFixedtimelineQualityrequirements
AcceptableprotocolfinaldraftMonitoringtypeMonitoringfrequencyMonitoringteamKeyriskindicatorsRiskmitigationplanDraftauditplan
ConfirmacceptanceofproceduresDiscusskeyriskindicatorsDiscussqualityrequirementsDecidemonitoringtype(central,onsite)DecidemonitoringfrequencyUpdateprotocoldraftPreparemonitoringplan
Risk-based MonitoringPlan(draft)DiscussQM
plan
Updateprotocolfinal
draft
ProjectManagementPlan
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FinalizationofProtocol
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Input Process Output
Finalcostestimation
Finalizeprotocol Fullprotocol
DesignPatientpopulationIndicationI/EcriteriaSamplesizeEndpointsAnalysismethodsTrialtimelineTrialcostTrialorganizationTrialcomplexityTrialdifficultyPotentialriskMonitoringplan
FixedfullinformationforprotocolFixedtrialcostCRFindex
InputfeasibilityresultintodraftprotocolRe-confirmvoiceofcustomerRe-confirmcustomerrequirementsDiscussoutputdata(Table,Figure,Listetc)UpdatedraftprotocolProtocolreviewbyteamProtocolreviewbyexpert
DraftRMP
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FinalizationofRMP
18/03/31 ProcessChart_臨床研究の品質向上ツール作成WG 40
Input Process Output
FinalProtocol Discussmonitoringplan
PMplanQMplanEndpointsAnalysismethodsTrialtimelineTrialorganizationTrialcomplexityMonitoringtypeMonitoringfrequencyMonitoringteamKeyriskindicatorsRiskmitigationplanDraftauditplan
AcceptablefinalmonitoringplanMonitoringtypeMonitoringfrequencyMonitoringteamKeyriskindicatorsRiskmitigationplanAuditplan
ConfirmacceptanceofproceduresDiscusskeyriskindicatorsDiscussqualityrequirementsDecidemonitoringtype(central,onsite)DecidemonitoringfrequencyUpdateprotocoldraftPreparemonitoringplan
Risk-based MonitoringPlan(Final)DraftRMP