ICH-CN

GuidanceforIndustryE6GoodClinicalPractice:ConsolidatedGuidanceICHApril1996GuidanceforIndustryE6GoodClinicalPractice:ConsolidatedGuidanceAdditionalcopiesareavailablefrom:theDrugInformationBranch(HFD-210),CenterforDrugEvaluationandResearch(CDER),5600FishersLane,Rockville,MD20857(Tel)301-827-4573(HFM-40)CenterforBiologicsEvaluationandResearch(CBER)1401RockvillePike,Rockville,MD20852-1448,(Fax)888-CBERFAXor301-827-3844(VoiceInformation)800-835-4709or301-827-1800U.S.DepartmentofHealthandHumanServicesFoodandDrugAdministrationCenterforDrugEvaluationandResearch(CDER)CenterforBiologicsEvaluationandResearch(CBER)April1996ICHTableofContentsINTRODUCTION..........................................................11.2.3.4.5.GLOSSARY.........................................................1THEPRINCIPLESOFICHGCP.........................................8INSTITUTIONALREVIEWBOARD/INDEPENDENTETHICSCOMMITTEE(IRB/IEC)..........................................................103.1Responsibilities.................................................103.2Composition,Functions,andOperations..............................113.3Procedures....................................................123.4Records......................................................13INVESTIGATOR....................................................134.1Investigator'sQualificationsandAgreements..........................134.2AdequateResources.............................................144.3MedicalCareofTrialSubjects.....................................144.4CommunicationwithIRB/IEC.....................................154.5CompliancewithProtocol........................................154.6InvestigationalProduct(s).........................................164.7RandomizationProceduresandUnblinding............................164.8InformedConsentofTrialSubjects..................................174.9RecordsandReports............................................214.10ProgressReports...............................................224.11SafetyReporting................................................224.12PrematureTerminationorSuspensionofaTrial........................234.13FinalReport(s)byInvestigator/Institution.............................23SPONSOR..........................................................245.1QualityAssuranceandQualityControl...............................245.2ContractResearchOrganization(CRO)..............................245.3MedicalExpertise...............................................245.4TrialDesign...................................................255.5TrialManagement,DataHandling,Recordkeeping,andIndependentDataMonitoringCommittee...........................................255.6InvestigatorSelection............................................275.7AllocationofDutiesandFunctions..................................275.8CompensationtoSubjectsandInvestigators...........................285.9Financing.....................................................285.10Notification/SubmissiontoRegulatoryAuthority(ies)....................28i6.7.8.5.11ConfirmationofReviewbyIRB/IEC................................285.12InformationonInvestigationalProduct(s).............................295.13Manufacturing,Packaging,Labeling,andCodingInvestigational...........295.14SupplyingandHandlingInvestigationalProduct(s)......................305.15RecordAccess.................................................315.16SafetyInformation..............................................315.17AdverseDrugReactionReporting..................................315.18Monitoring....................................................325.19Audit........................................................365.20Noncompliance.................................................375.21PrematureTerminationorSuspensionofaTrial........................375.22ClinicalTrial/StudyReports.......................................375.23MulticenterTrials...............................................37CLINICALTRIALPROTOCOLANDPROTOCOL.........................386.1GeneralInformation.............................................386.2BackgroundInformation..........................................396.3TrialObjectivesandPurpose......................................396.4TrialDesign...................................................396.5SelectionandWithdrawalofSubjects................................406.6TreatmentofSubjects............................................406.7AssessmentofEfficacy...........................................416.8AssessmentofSafety............................................416.9Statistics......................................................416.10DirectAccesstoSourceData/Documents.............................426.11QualityControlandQualityAssurance...............................426.12Ethics........................................................426.13DataHandlingandRecordkeeping..................