SDA-2003-GCP-药物临床试验质量管理规范英文版

1GoodClinicalPracticeofPharmaceuticalProducts[SFDAorderNo.3,EffectiveonSeptember1,2003]Chapter1:GeneralProvisionsArticle1:ThisGoodClinicalPracticeofPharmaceuticalProducts(hereinafter“GCP”)ispromulgatedinaccordancewiththeDrugAdministrationLawofPRCandImplementingRegulationofDrugAdministrationLawofPRC,makingreferencetointernationallyrecognizedprinciplestoensurethestandardizationofclinicaltrialsofdrugswhichwillresultinscientificreliability,andtheprotectionoftheinterestsandsafetyofthehumansubject.Article2:ThisGCPisaregulationforthestandardizationofthewholeprocessofaclinicaltrial,includingprotocoldesign,organizingimplementation,monitoring,auditing,recording,analysis,summarizationandreporting.Article3:ThisGCPistobeobservedinallphasesofaclinicaltrial,thebioavailabilitytrialorbiologicalequivalencetrialonthehumanbody.Article4:AllresearchinvolvinghumansubjectsmustconformtotheDeclarationofHelsinkiofWorldMedicalAssociation(Appendix1)i.e.fairness,respectofhumanintegrity,maximizethebenefitsandminimizeanyharmtothehumansubject.Chapter2:PreparationsandPrerequisitesforConductingaClinicalTrialArticle5:Sufficientscientificbasismustbeprovidedforconductingclinicaltrialsofdrugs.Thepurposeofaclinicaltrial,theproblemstobesolved,mustbeconsideredbeforeconductingatrialonhumansubjects.Theanticipatedbenefitsandrisksforthehumansubjectsandpublichealthmustbebalanced.Theanticipatedbenefitsmustexceedthepossibleharm.Theselectionofclinicaltrialmethodsmustconformtoscientificandethicalcriteria.Article6:Thedrugstobeusedinaclinicaltrialshallbepreparedandsuppliedbythesponsor.Beforeconductingaclinicaltrial,thesponsormustprovidethepre-clinicalstudydocuments,includingtheformulation,manufacturingprocessandthequalityinspectionresultsofthedrug.Allpre-clinicalstudyinformationsuppliedbythesponsormustconformtotherequirementsoftherespectivecorrespondingphase(s)oftheclinicaltrial.Thesponsorshallalsoprovidethedocumentsrelatingtotheeffectivenessandsafetyofthedrugobtainedfromclinicaltrialsalreadycompletedorbeingconductedinotherplaces.GMPshallbeconformedformanufacturingtheinvestigationalproduct.Article7:Theequipmentandconditionsoftheinstitutionwheretheclinicaltrialwillbeconductedshallmeetrequirementsforsafetyandefficacy..Allinvestigatorsshallbequalifiedforundertakingthetrialbytheirspecialtyandability,andhavereceivedtraining.Beforestartingaclinicaltrial,awrittenagreementshallbereachedbetweentheinvestigatorandthesponsorupontrialprotocol,monitoring,auditingandstandardoperatingprocedures,aswellastheresponsibilitiesofeachpartyinthetrial.2Chapter3:ProtectionofaHumanSubject’sInterestsArticle8:Inadrugclinicaltrial,thehumansubject’sinterestsmustbefullyprotectedandthetrialshallbescientificandreliable.Thehumansubject’sinterests,safetyandhealthmustbehigherthantheconsiderationforscienceandsocialinterests.TheuseofanEthicsCommitteeandinformedconsentformareimportantmethodstoprotectthehumansubject.Article9:Inordertoprotecttheinterestsofhumansubjects,anindependentEthicsCommitteeshallbeformedandsuchinformationfiledwithSFDA.TheEthicsCommitteeshallconsistofatleastfivepeopleofdifferentgendersincludingthoseworkinginthemedicalprofession,notworkinginthemedicalprofession,lawexperts,andmembersfromotherunits.ThestructureandworkoftheEthicsCommitteeshallnotbeinfluencedbythoseparticipatinginthetrial.Article10:TheprotocolofthetrialmustbereviewedandapprovedbytheEthicsCommittee.Whenconductingaclinicaltrial,anyamendmentoftheprotocolmaynotbeimplementedwithoutapprovalfromtheEthicsCommittee.AnyseriousadverseeventsthatoccurduringthetrialshallbereportedtotheEthicsCommittee..Article11:ThedecisionsregardingreviewandapprovaloftheprotocolbytheEthicsCommitteeshallbedecidedthroughdiscussionandvoting.EthnicsCommitteemembersshallavoidparticipatingintheclinicaltrial.Expertswhoarenotmembersofthecommitteemaybeinvitedtoattendthemeetingwhennecessary,butmaynotvote.TheEthicsCommitteeshallestablishitsworkingprocedures.Writtenrecordsforallmeetingsandtheresolutionsadoptedduringmeetingsshallbekeptforfiveyearsafterthecompletionofaclinicaltrial.Article12:TheEthicsCommitteeshallstrictlyexaminethefollowingaspectsoftheprotocolinordertoprotecttheinterestsofhumansubjects:1.thequalificationsandexperienceofinvestigatorsandwhethertheywillhaveenoughtimetoparticipateintheclinicaltrial,andwhetherthestaffandequipmentconformwiththerequirementsofthetrial;2.whethertheethicalprinciplesarefullyconsideredintheprotocol,includingthepurposeoftheinvestigation,theanticipatedrisksandbenefitstothehumansubjectandotherpeople,andwhetherthetrialisscientificallydesigned;3.whetherthemethodofhumansubjectadmissionandtheinformationaboutthetrialprovidedtothehumansubject,ortheirfamiliesorlegalguardiansorlegalrepresentatives,iscompleteandeasytounderstand,andwhetherthemethodusedtoobtaininformedconsentformisproper;4.thetreatmentorinsuranceprovidedtoahumansubjectwhoisharmedorevendiesduetohisparticipationintheclinicaltrial.5.whethertherecommendationstomodifytheprotocolareacceptable;and,6.periodicexaminationofthedegreeofriskstohumansubjectsparticipatingintheclinica