ICH-GCP E6

INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSEICHHARMONISEDTRIPARTITEGUIDELINEGUIDELINEFORGOODCLINICALPRACTICEE6(R1)CurrentStep4versiondated10June1996(includingthePostStep4corrections)ThisGuidelinehasbeendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.E6(R1)DocumentHistoryFirstCodificationHistoryDateNewCodificationNovember2005E6ApprovalbytheSteeringCommitteeunderStep2andreleaseforpublicconsultation.27April1995E6E6ApprovalbytheSteeringCommitteeunderStep4andrecommendedforadoptiontothethreeICHregulatorybodies.1May1996E6CurrentStep4versionE6ApprovalbytheSteeringCommitteeofPost-Step4editorialcorrections.10June1996E6(R1)GUIDELINEFORGOODCLINICALPRACTICEICHHarmonisedTripartiteGuidelineHavingreachedStep4oftheICHProcessattheICHSteeringCommitteemeetingon1May1996,thisguidelineisrecommendedforadoptiontothethreeregulatorypartiestoICH(ThisdocumentincludesthePostStep4correctionsagreedbytheSteeringCommitteeon10June1996)TABLEOFCONTENTSINTRODUCTION.............................................................................................................11.GLOSSARY.............................................................................................................22.THEPRINCIPLESOFICHGCP........................................................................83.INSTITUTIONALREVIEWBOARD/INDEPENDENTETHICSCOMMITTEE(IRB/IEC).......................................................................................93.1Responsibilities.........................................................................................................93.2Composition,FunctionsandOperations...............................................................113.3Procedures..............................................................................................................113.4Records....................................................................................................................124.INVESTIGATOR..................................................................................................124.1Investigator'sQualificationsandAgreements......................................................124.2AdequateResources...............................................................................................124.3MedicalCareofTrialSubjects...............................................................................134.4CommunicationwithIRB/IEC...............................................................................134.5CompliancewithProtocol......................................................................................134.6InvestigationalProduct(s)......................................................................................144.7RandomizationProceduresandUnblinding.........................................................154.8InformedConsentofTrialSubjects.......................................................................154.9RecordsandReports...............................................................................................184.10ProgressReports.....................................................................................................194.11SafetyReporting.....................................................................................................194.12PrematureTerminationorSuspensionofaTrial................................................194.13FinalReport(s)byInvestigator..............................................................................205.SPONSOR..............................................................................................................205.1QualityAssuranceandQualityControl................................................................205.2ContractResearchOrganization(CRO)................................................................205.3MedicalExpertise...................................................................................................215.4TrialDesign............................................................................................................215.5TrialManagement,DataHandling,andRecordKeeping....................................21iGuidelineforGoodClinicalPractice5.6InvestigatorSelection............................................................................................225.7AllocationofResponsibilities................................................................................235.8CompensationtoSubjectsandInvestigators.......................................................235.9Financing................................................................................................................235.10Notification/SubmissiontoRegulatoryAuthority(ies).........................................235.11ConfirmationofReviewbyIRB/IEC................................