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ICH三方协调指导原则E6ICHGCP指导原则INTRODUCTION前言GoodClinicalPractice(GCP)isaninternationalethicalandscientificqualitystandardfordesigning,conducting,recordingandreportingtrialsthatinvolvetheparticipationofhumansubjects.Compliancewiththisstandardprovidespublicassurancethattherights,safetyandwell-beingoftrialsubjectsareprotected,consistentwiththeprinciplesthathavetheiroriginintheDeclarationofHelsinki,andthattheclinicaltrialdataarecredible.临床试验管理规范（GCP）是设计、实施、记录和报告设计人类对象参加的试验国际性伦理和科学质量标准。遵循这一标准为保护对象的权利、安全性和健康，为与源于赫尔辛基宣言的原则保持一致以及临床试验数据的可信性提供了公众保证。TheobjectiveofthisICHGCPGuidelineistoprovideaunifiedstandardfortheEuropeanUnion(EU),JapanandtheUnitedStatestofacilitatethemutualacceptanceofclinicaldatabytheregulatoryauthoritiesinthesejurisdictions.ICH-GCP指导原则的目的是为欧盟、日本和美国提供统一的标准，以促进这些管理当局在其权限内相互接受临床数据。TheguidelinewasdevelopedwithconsiderationofthecurrentgoodclinicalpracticesoftheEuropeanUnion,Japan,andtheUnitedStates,aswellasthoseofAustralia,Canada,theNordiccountriesandtheWorldHealthOrganization(WHO).本指导原则的发展考虑了欧盟、日本、美国，以及澳大利亚、加拿大、北欧国家和世界卫生组织（WHO）的现行GCP。Thisguidelineshouldbefollowedwhengeneratingclinicaltrialdatathatareintendedtobesubmittedtoregulatoryauthorities.在产生打算提交给管理当局的临床数据时应当遵循本指导原则。Theprinciplesestablishedinthisguidelinemayalsobeappliedtootherclinicalinvestigationsthatmayhaveanimpactonthesafetyandwell-beingofhumansubjects.本指导原则中确立的原则也可应用于可能影响人类对象安全和健康的其他临床研究。1.GLOSSARY1.术语1.1AdverseDrugReaction(ADR)药品不良反应（ADR）Inthepre-approvalclinicalexperiencewithanewmedicinalproductoritsnewusages,particularlyasthetherapeuticdose(s)maynotbeestablished:allnoxiousandunintendedresponsestoamedicinalproductrelatedtoanydoseshouldbeconsideredadversedrugreactions.Thephraseresponsestoamedicinalproductmeansthatacausalrelationshipbetweenamedicinalproductandanadverseeventisatleastareasonablepossibility,i.e.therelationshipcannotberuledout.在一个新的药品或药品的新用途在批准之前的临床实践，尤其是治疗剂量尚未确定前，ADR是指与药物任何剂量有关的所有有害的和非意求的反应都应被考虑为药物不良反应。该术语用于药品是指在药品与不良反应之间的因果关系至少有一个合理的可能性，即不能排除这种关系。Regardingmarketedmedicinalproducts:aresponsetoadrugwhichisnoxiousandunintendedandwhichoccursatdosesnormallyusedinmanforprophylaxis,diagnosis,ortherapyofdiseasesorformodificationofphysiologicalfunction(seetheICHGuidelineforClinicalSafetyDataManagement:DefinitionsandStandardsforExpeditedReporting).对已上市药品，ADR指人对用于预防、诊断或治疗疾病或改善生理功能的药物在常用剂量出现的有害和非意求反应（参见ICH临床安全性数据管理指导原则：快速报告的定义和标准）。1.2AdverseEvent(AE)不良事件（AE）Anyuntowardmedicaloccurrenceinapatientorclinicalinvestigationsubjectadministeredapharmaceuticalproductandwhichdoesnotnecessarilyhaveacausalrelationshipwiththistreatment.Anadverseevent(AE)canthereforebeanyunfavourableandunintendedsign(includinganabnormallaboratoryfinding),symptom,ordiseasetemporallyassociatedwiththeuseofamedicinal(investigational)product,whetherornotrelatedtothemedicinal(investigational)product(seetheICHGuidelineforClinicalSafetyDataManagement:DefinitionsandStandardsforExpeditedReporting).在用药病人或临床研究对象中发生的任何不幸医疗事件，他不一定要与治疗有因果关系。因此，一个不良事件（AE）可以是与使用（研究）药物在时间上相关的任何不利的和非意求的征兆（包括异常的实验室发现）、症状或疾病，而不管其是否与药物有关（参见ICH临床安全性数据管理指导原则：快速报告的定义和标准）。1.3Amendment(totheprotocol)修改（试验方案）SeeProtocolAmendment.见试验方案修改1.4ApplicableRegulatoryRequirement(s)适用的管理要求Anylaw(s)andregulation(s)addressingtheconductofclinicaltrialsofinvestigationalproducts.有关实施试验用药品临床试验的任何法律和法规。1.5Approval(inrelationtoInstitutionalReviewBoards)批准（机构审评委员会）TheaffirmativedecisionoftheIRBthattheclinicaltrialhasbeenreviewedandmaybeconductedattheinstitutionsitewithintheconstraintssetforthbytheIRB,theinstitution,GoodClinicalPractice(GCP),andtheapplicableregulatoryrequirements.IRB表示赞成的决定：指对一项临床试验已经进行审评，并可在IRB、研究机构、GCP和适用管理要求的约束下由研究机构方实施。1.6Audit稽查Asystematicandindependentexaminationoftrialrelatedactivitiesanddocumentstodeterminewhethertheevaluatedtrialrelatedactivitieswereconducted,andthedatawererecorded,analyzedandaccuratelyreportedaccordingtotheprotocol,sponsor'sstandardoperatingprocedures(SOPs),GoodClinicalPractice(GCP),andtheapplicableregulatoryrequirement(s).对试验相关活动和文件进行系统和独立的监察，以判定试验的实施和数据的记录、分析与报告是否符合试验方案、申办者的标准操作程序（SOP）、临床试验管理规范（GCP）以及适用的管理要求。1.7AuditCertificate稽查证书Adeclarationofconfirmationbytheauditorthatanaudithastakenplace.稽查员确认已进行稽查的声明。1.8AuditReport稽查报告Awrittenevaluationbythesponsor'sauditoroftheresultsoftheaudit.申办者方稽查关于稽查结果的书面评价1.9AuditTrail稽查轨迹Documentationthatallowsreconstructionofthecourseofevents.允许重复出现事件过程的文件。1.10Blinding/Masking设盲Aprocedureinwhichoneormorepartiestothetrialarekeptunawareofthetreatmentassignment(s).Single-blindingusuallyreferstothesubject(s)beingunaware,anddouble-blindingusuallyreferstothesubject(s),investigator(s),monitor,and,insomecases,dataanalyst(s)beingunawareofthetreatmentassignment(s).一种使试验的一个或几个部分的人员不知道治疗分配的程序。单盲通常指对象不知道；双盲通常指对象、研究人员、监察员以及在某些情况下数据分析人员也不知道治疗分配。1.11CaseReportForm(CRF)病例报告表（CRF）Aprinted,optical,orelectronicdocumentdesignedtorecordalloftheprotocolrequiredinformationtobereportedtothesponsoroneachtrialsubject.设计用来记录试验方案要求向申办者报告的有关每一例对象的全部信息的印刷的、光学的或电子的文件。1.12ClinicalTrial/Study临床试验/研究Anyinvestigationinhumansubjectsintendedtodiscoverorverifytheclinical,pharmacologicaland/orotherphar