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2020-03-18

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TheEuropeanAgencyfortheEvaluationofMedicinalProducts7WestferryCircus,CanaryWharf,London,E144HB,UKTel.(44-20)74188400Fax(44-20)74188613E-mail:mail@emea.eu.intEMEA2002Reproductionand/ordistributionofthisdocumentisauthorisedfornoncommercialpurposesonlyprovidedtheEMEAisacknowledgedICHTopicE6GuidelineforGoodClinicalPracticeStep5,ConsolidatedGuideline1.5.96NOTEFORGUIDANCEONGOODCLINICALPRACTICE(CPMP/ICH/135/95)*TRANSMISSIONTOCPMPJuly1996FINALAPPROVALBYCPMP17July1996DATEFORCOMINGINTOOPERATION(STUDIESCOMMENCINGAFTER)17January1997POSTSTEPERRATA(linguisticminorcorrections)July2002*includingpostStep4errataStatus:September1997CPMP/ICH/135/95,Jan.97EMEA2002iGUIDELINEFORGOODCLINICALPRACTICEICHHarmonisedTripartiteGuidelineTABLEOFCONTENTSTABLEOFCONTENTS......................................................................................................iINTRODUCTION................................................................................................................11.GLOSSARY...............................................................................................................12.THEPRINCIPLESOFICHGCP..........................................................................93.INSTITUTIONALREVIEWBOARD/INDEPENDENTETHICSCOMMITTEE(IRB/IEC)......................................................................103.1Responsibilities.........................................................................................................103.2Composition,FunctionsandOperations...................................................................113.3Procedures.................................................................................................................123.4Records......................................................................................................................134.INVESTIGATOR...................................................................................................134.1Investigator'sQualificationsandAgreements..........................................................134.2AdequateResources..................................................................................................134.3MedicalCareofTrialSubjects.................................................................................144.4CommunicationwithIRB/IEC.................................................................................144.5CompliancewithProtocol.........................................................................................144.6InvestigationalProduct(s).........................................................................................154.7RandomizationProceduresandUnblinding.............................................................154.8InformedConsentofTrialSubjects..........................................................................164.9RecordsandReports.................................................................................................194.10ProgressReports.......................................................................................................204.11SafetyReporting.......................................................................................................204.12PrematureTerminationorSuspensionofaTrial......................................................204.13FinalReport(s)byInvestigator.................................................................................215.SPONSOR................................................................................................................215.1QualityAssuranceandQualityControl....................................................................215.2ContractResearchOrganization(CRO)...................................................................215.3MedicalExpertise.....................................................................................................215.4TrialDesign...............................................................................................................225.5TrialManagement,DataHandling,andRecordKeeping.........................................225.6InvestigatorSelection................................................................................................235.7AllocationofResponsibilities...................................................................................24CPMP/ICH/135/95,Jan.97EMEA2002ii5.8CompensationtoSubjectsandInvestigators............................................................245.9Financing...................................................................................................................245.10Notification/SubmissiontoRegulatoryAuthority(ies).............................................245.11ConfirmationofReviewbyIRB/IEC.......................................................................245.12InformationonInvestigationalProduct(s)................................................................255.13Manufacturing,Packaging,Labelling,andCodingInvestigationalProduct(s)......