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1、INTERNATIONALCONFERENCEONHARMONISATIONOFTECHNICALREQUIREMENTSFORREGISTRATIONOFPHARMACEUTICALSFORHUMANUSEICHHARMONISEDTRIPARTITEGUIDELINEGUIDELINEFORGOODCLINICALPRACTICEE6(R1)CurrentStep4versiondated10June1996(includingthePostStep4corrections)ThisGuidelinehas
2、beendevelopedbytheappropriateICHExpertWorkingGroupandhasbeensubjecttoconsultationbytheregulatoryparties,inaccordancewiththeICHProcess.AtStep4oftheProcessthefinaldraftisrecommendedforadoptiontotheregulatorybodiesoftheEuropeanUnion,JapanandUSA.E6(R1)DocumentHi
3、storyNewFirstCodificationHistoryDateCodificationNovember2005E6ApprovalbytheSteeringCommitteeunderStep227E6andreleaseforpublicconsultation.April1995E6ApprovalbytheSteeringCommitteeunderStep41E6andrecommendedforadoptiontothethreeICHMayregulatorybodies.1996Curr
4、entStep4versionE6ApprovalbytheSteeringCommitteeofPost-Step410E6(R1)editorialcorrections.June1996GUIDELINEFORGOODCLINICALPRACTICEICHHarmonisedTripartiteGuidelineHavingreachedStep4oftheICHProcessattheICHSteeringCommitteemeetingon1May1996,thisguidelineisrecomme
5、ndedforadoptiontothethreeregulatorypartiestoICH(ThisdocumentincludesthePostStep4correctionsagreedbytheSteeringCommitteeon10June1996)TABLEOFCONTENTSINTRODUCTION...................................................................................................
6、..........11.GLOSSARY.............................................................................................................22.THEPRINCIPLESOFICHGCP........................................................................83.INSTITUTIONALREVIEWBOARD/INDE
7、PENDENTETHICSCOMMITTEE(IRB/IEC).......................................................................................93.1Responsibilities.........................................................................................................93.2Composition
8、,FunctionsandOperations...............................................................113.3Procedures.............................................................................................
