ICH-GCP中英文對(duì)照(完整)

實(shí)用文檔ICH三方協(xié)調(diào)指導(dǎo)原則E6ICHGCP指導(dǎo)原則INTRODUCTION前言GoodClinicalPractice(GCP)isaninternationalethicalandscientificqualitystandardfordesigning,conducting,recordingandreportingtrialsthatinvolvetheparticipationofhumansubjects.Compliancewiththisstandardprovidespublicassurancethattherights,safetyandwell-beingoftrialsubjectsareprotected,consistentwiththeprinciplesthathavetheiroriginintheDeclarationofHelsinki,andthattheclinicaltrialdataarecredible.臨床試驗(yàn)管理規(guī)范(GCP)是設(shè)計(jì)、實(shí)施、記錄和報(bào)告設(shè)計(jì)人類對(duì)象參加的試驗(yàn)國際性倫理和科學(xué)質(zhì)量標(biāo)準(zhǔn)。遵循這一標(biāo)準(zhǔn)為保護(hù)對(duì)象的權(quán)利、安全性和健康,為與源于赫爾辛基宣言的原則保持一致以及臨床試驗(yàn)數(shù)據(jù)的可信性提供了公眾保證。TheobjectiveofthisICHGCPGuidelineistoprovideaunifiedstandardfortheEuropeanUnion(EU),JapanandtheUnitedStatestofacilitatethemutualacceptanceofclinicaldatabytheregulatoryauthoritiesinthesejurisdictions.ICH-GCP指導(dǎo)原則的目的是為歐盟、日本和美國提供統(tǒng)一的標(biāo)準(zhǔn),以促進(jìn)這些管理當(dāng)局在其權(quán)限內(nèi)相互接受臨床數(shù)據(jù)。TheguidelinewasdevelopedwithconsiderationofthecurrentgoodclinicalpracticesoftheEuropeanUnion,Japan,andtheUnitedStates,aswellasthoseofAustralia,Canada,theNordiccountriesandtheWorldHealthOrganization(WHO).本指導(dǎo)原則的發(fā)展考慮了歐盟、日本、美國,以及澳大利亞、加拿大、北歐國家和世界衛(wèi)生組織(WHO)的現(xiàn)行GCP。Thisguidelineshouldbefollowedwhengeneratingclinicaltrialdatathatareintendedtobesubmittedtoregulatoryauthorities.在產(chǎn)生打算提交給管理當(dāng)局的臨床數(shù)據(jù)時(shí)應(yīng)當(dāng)遵循本指導(dǎo)原則。Theprinciplesestablishedinthisguidelinemayalsobeappliedtootherclinicalinvestigationsthatmayhaveanimpactonthesafetyandwell-beingofhumansubjects.本指導(dǎo)原則中確立的原則也可應(yīng)用于可能影響人類對(duì)象安全和健康的其他臨床研究。1.GLOSSARY1.術(shù)語1.1AdverseDrugReaction(ADR)藥品不良反應(yīng)(ADR)Inthepre-approvalclinicalexperiencewithanewmedicinalproductoritsnewusages,particularlyasthetherapeuticdose(s)maynotbeestablished:allnoxiousandunintendedresponsestoamedicinalproductrelatedtoanydoseshouldbeconsideredadversedrugreactions.Thephraseresponsestoamedicinalproductmeansthatacausalrelationshipbetweenamedicinalproductandanadverseeventisatleastareasonablepossibility,i.e.therelationshipcannotberuledout.在一個(gè)新的藥品或藥品的新用途在批準(zhǔn)之前的臨床實(shí)踐,尤其是治療劑量尚未確定前,ADR是指與藥物任何劑量有關(guān)的所有有害的和非意求的反應(yīng)都應(yīng)被考慮為藥物不良反應(yīng)。該術(shù)語用于藥品是指在藥品與不良反應(yīng)之間的因果關(guān)系至少有一個(gè)合理的可能性,即不能排除這種關(guān)系。Regardingmarketedmedicinalproducts:aresponsetoadrugwhichisnoxiousandunintendedandwhichoccursatdosesnormallyusedinmanforprophylaxis,diagnosis,ortherapyofdiseasesorformodificationofphysiologicalfunction(seetheICHGuidelineforClinicalSafetyDataManagement:DefinitionsandStandardsforExpeditedReporting).對(duì)已上市藥品,ADR指人對(duì)用于預(yù)防、診斷或治療疾病或改善生理功能的藥物在常用劑量出現(xiàn)的有害和非意求反應(yīng)(參見ICH臨床安全性數(shù)據(jù)管理指導(dǎo)原則:快速報(bào)告的定義和標(biāo)準(zhǔn))。1.2AdverseEvent(AE)不良事件(AE)Anyuntowardmedicaloccurrenceinapatientorclinicalinvestigationsubjectadministeredapharmaceuticalproductandwhichdoesnotnecessarilyhaveacausalrelationshipwiththistreatment.Anadverseevent(AE)canthereforebeanyunfavourableandunintendedsign(includinganabnormallaboratoryfinding),symptom,ordiseasetemporallyassociatedwiththeuseofamedicinal(investigational)product,whetherornotrelatedtothemedicinal(investigational)product(seetheICHGuidelineforClinicalSafetyDataManagement:DefinitionsandStandardsforExpeditedReporting).在用藥病人或臨床研究對(duì)象中發(fā)生的任何不幸醫(yī)療事件,他不一定要與治療有因果關(guān)系。因此,一個(gè)不良事件(AE)可以是與使用(研究)藥物在時(shí)間上相關(guān)的任何不利的和非意求的征兆(包括異常的實(shí)驗(yàn)室發(fā)現(xiàn))、癥狀或疾病,而不管其是否與藥物有關(guān)(參見ICH臨床安全性數(shù)據(jù)管理指導(dǎo)原則:快速報(bào)告的定義和標(biāo)準(zhǔn))。1.3Amendment(totheprotocol)修改(試驗(yàn)方案)SeeProtocolAmendment.見試驗(yàn)方案修改1.4ApplicableRegulatoryRequirement(s)適用的管理要求Anylaw(s)andregulation(s)addressingtheconductofclinicaltrialsofinvestigationalproducts.有關(guān)實(shí)施試驗(yàn)用藥品臨床試驗(yàn)的任何法律和法規(guī)。1.5Approval(inrelationtoInstitutionalReviewBoards)批準(zhǔn)(機(jī)構(gòu)審評(píng)委員會(huì))TheaffirmativedecisionoftheIRBthattheclinicaltrialhasbeenreviewedandmaybeconductedattheinstitutionsitewithintheconstraintssetforthbytheIRB,theinstitution,GoodClinicalPractice(GCP),andtheapplicableregulatoryrequirements.IRB表示贊成的決定:指對(duì)一項(xiàng)臨床試驗(yàn)已經(jīng)進(jìn)行審評(píng),并可在IRB、研究機(jī)構(gòu)、GCP和適用管理要求的約束下由研究機(jī)構(gòu)方實(shí)施。1.6Audit稽查Asystematicandindependentexaminationoftrialrelatedactivitiesanddocumentstodeterminewhethertheevaluatedtrialrelatedactivitieswereconducted,andthedatawererecorded,analyzedandaccuratelyreportedaccordingtotheprotocol,sponsor'sstandardoperatingprocedures(SOPs),GoodClinicalPractice(GCP),andtheapplicableregulatoryrequirement(s).對(duì)試驗(yàn)相關(guān)活動(dòng)和文件進(jìn)行系統(tǒng)和獨(dú)立的監(jiān)察,以判定試驗(yàn)的實(shí)施和數(shù)據(jù)的記錄、分析與報(bào)告是否符合試驗(yàn)方案、申辦者的標(biāo)準(zhǔn)操作程序(SOP)、臨床試驗(yàn)管理規(guī)范(GCP)以及適用的管理要求。1.7AuditCertificate稽查證書Adeclarationofconfirmationbytheauditorthatanaudithastakenplace.稽查員確認(rèn)已進(jìn)行稽查的聲明。1.8AuditReport稽查報(bào)告Awrittenevaluationbythesponsor'sauditoroftheresultsoftheaudit.申辦者方稽查關(guān)于稽查結(jié)果的書面評(píng)價(jià)1.9AuditTrail稽查軌跡Documentationthatallowsreconstructionofthecourseofevents.允許重復(fù)出現(xiàn)事件過程的文件。1.10Blinding/Masking設(shè)盲Aprocedureinwhichoneormorepartiestothetrialarekeptunawareofthetreatmentassignment(s).Single-blindingusuallyreferstothesubject(s)beingunaware,anddouble-blindingusuallyreferstothesubject(s),investigator(s),monitor,and,insomecases,dataanalyst(s)beingunawareofthetreatmentassignment(s).一種使試驗(yàn)的一個(gè)或幾個(gè)部分的人員不知道治療分配的程序。單盲通常指對(duì)象不知道;雙盲通常指對(duì)象、研究人員、監(jiān)察員以及在某些情況下數(shù)據(jù)分析人員也不知道治療分配。1.11CaseReportForm(CRF)病例報(bào)告表(CRF)Aprinted,optical,orelectronicdocumentdesignedtorecordalloftheprotocolrequiredinformationtobereportedtothesponsoroneachtrialsubject.設(shè)計(jì)用來記錄試驗(yàn)方案要求向申辦者報(bào)告的有關(guān)每一例對(duì)象的全部信息的印刷的、光學(xué)的或電子的文件。1.12ClinicalTrial/Study臨床試驗(yàn)/研究Anyinvestigationinhumansubjectsintendedtodiscoverorverifytheclinical,pharmacologicaland/orotherpharmacodynamiceffectsofaninvestigationalproduct(s),and/ortoidentifyanyadversereactionstoaninvestigationalproduct(s),and/ortostudyabsorption,distribution,metabolism,andexcretionofaninvestigationalproduct(s)withtheobjectofascertainingitssafetyand/orefficacy.Thetermsclinicaltrialandclinicalstudyaresynonymous.在人類對(duì)象進(jìn)行的任何意在發(fā)現(xiàn)或證實(shí)一種試驗(yàn)用藥品的臨床、藥理學(xué)和/或其他藥效學(xué)作用;和/或確定一種試驗(yàn)用藥品的任何不良反應(yīng);和/或研究一種試驗(yàn)用藥品的吸收、分布、代謝和排泄,以確定藥物的安全性和/或有效性的研究。術(shù)語臨床試驗(yàn)和臨床研究同義。1.13ClinicalTrial/StudyReport臨床試驗(yàn)/研究報(bào)告Awrittendescriptionofatrial/studyofanytherapeutic,prophylactic,ordiagnosticagentconductedinhumansubjects,inwhichtheclinicalandstatisticaldescription,presentations,andanalysesarefullyintegratedintoasinglereport(seetheICHGuidelineforStructureandContentofClinicalStudyReports).在人類對(duì)象進(jìn)行的任何治療、預(yù)防或診斷劑的試驗(yàn)/研究的書面描述。臨床和統(tǒng)計(jì)描述、陳述和分析全部列入該單份報(bào)告(見ICH臨床研究報(bào)告的結(jié)構(gòu)和內(nèi)容指導(dǎo)原則)。1.14Comparator(Product)對(duì)照(藥物)Aninvestigationalormarketedproduct(i.e.,activecontrol),orplacebo,usedasareferenceinaclinicaltrial.臨床試驗(yàn)中用做對(duì)照的試驗(yàn)用藥品或市售藥物(即陽性對(duì)照)或安慰劑。1.15Compliance(inrelationtotrials)依從性(關(guān)于試驗(yàn)的)Adherencetoallthetrial-relatedrequirements,GoodClinicalPractice(GCP)requirements,andtheapplicableregulatoryrequirements.遵循與試驗(yàn)有關(guān)的所有要求、臨床試驗(yàn)管理規(guī)范(GCP)要求和適用的管理要求。1.16Confidentiality保密性Preventionofdisclosure,tootherthanauthorizedindividuals,ofasponsor'sproprietaryinformationorofasubject'sidentity.不得向未經(jīng)授權(quán)的個(gè)人泄漏申辦者所有的資料或?qū)ο蟮纳矸荨?.17Contract合同Awritten,dated,andsignedagreementbetweentwoormoreinvolvedpartiesthatsetsoutanyarrangementsondelegationanddistributionoftasksandobligationsand,ifappropriate,onfinancialmatters.Theprotocolmayserveasthebasisofacontract.在兩個(gè)或幾個(gè)有關(guān)方之間的一份書面的、有日期和簽字的協(xié)議,其中陳述了關(guān)于工作和責(zé)任和分派的安排,以及關(guān)于財(cái)務(wù)問題的安排。試驗(yàn)方案可以作為合同的基礎(chǔ)。1.18CoordinatingCommittee協(xié)調(diào)委員會(huì)Acommitteethatasponsormayorganizetocoordinatetheconductofamulticentretrial.申辦者組織的協(xié)調(diào)實(shí)施多中心試驗(yàn)的委員會(huì)。1.19CoordinatingInvestigator協(xié)調(diào)研究者Aninvestigatorassignedtheresponsibilityforthecoordinationofinvestigatorsatdifferentcentresparticipatinginamulticentretrial.被指定負(fù)責(zé)協(xié)調(diào)參加一項(xiàng)多中心試驗(yàn)的各中心研究者工作的一名研究者。1.20ContractResearchOrganization(CRO)合同研究組織Apersonoranorganization(commercial,academic,orother)contractedbythesponsortoperformoneormoreofasponsor'strial-relateddutiesandfunctions.與申辦者訂立契約完成一個(gè)或多個(gè)有關(guān)申辦者方的試驗(yàn)任務(wù)和功能的個(gè)人或組織(商業(yè)性的,學(xué)術(shù)的或其他)。1.21DirectAccess直接訪問Permissiontoexamine,analyze,verify,andreproduceanyrecordsandreportsthatareimportanttoevaluationofaclinicaltrial.Anyparty(e.g.,domesticandforeignregulatoryauthorities,sponsor'smonitorsandauditors)withdirectaccessshouldtakeallreasonableprecautionswithintheconstraintsoftheapplicableregulatoryrequirement(s)tomaintaintheconfidentialityofsubjects'identitiesandsponsor’sproprietaryinformation.允許監(jiān)察、分析、核對(duì)和復(fù)制任何對(duì)于評(píng)價(jià)臨床試驗(yàn)有重要意義的記錄和報(bào)告。直接訪問的任何一方(如國內(nèi)和國外的管理當(dāng)局,申辦者方的監(jiān)察員和稽查員)應(yīng)當(dāng)受適用管理要求的缺書,采取一切合理的預(yù)防措施維護(hù)對(duì)象身份和申辦者資料的保密性。1.22Documentation文件Allrecords,inanyform(including,butnotlimitedto,written,electronic,magnetic,andopticalrecords,andscans,x-rays,andelectrocardiograms)thatdescribeorrecordthemethods,conduct,and/orresultsofatrial,thefactorsaffectingatrial,andtheactionstaken.描述或記錄試驗(yàn)的方法、實(shí)施和/或結(jié)果,影響試驗(yàn)的因素,以及采取的措施等的任何形式的記錄(包括但不限于書面、電子、磁性和光學(xué)的記錄,以及掃描、X射線和心電圖)。1.23EssentialDocuments必需文件Documentswhichindividuallyandcollectivelypermitevaluationoftheconductofastudyandthequalityofthedataproduced(see8.EssentialDocumentsfortheConductofaClinicalTrial).指各自和合在一起允許評(píng)價(jià)一個(gè)研究的執(zhí)行情況和所得數(shù)據(jù)的質(zhì)量文件(見8.實(shí)施臨床試驗(yàn)的必需文件)。1.24GoodClinicalPractice(GCP)臨床試驗(yàn)管理規(guī)范(GCP)Astandardforthedesign,conduct,performance,monitoring,auditing,recording,analyses,andreportingofclinicaltrialsthatprovidesassurancethatthedataandreportedresultsarecredibleandaccurate,andthattherights,integrity,andconfidentialityoftrialsubjectsareprotected.是臨床試驗(yàn)設(shè)計(jì)、實(shí)施、執(zhí)行、監(jiān)察、稽查、記錄、分析和報(bào)告的標(biāo)準(zhǔn),它為數(shù)據(jù)和所報(bào)告結(jié)果的可信性和準(zhǔn)確性提供了保證,并保護(hù)試驗(yàn)對(duì)象的權(quán)利、完整性和機(jī)密性。1.25IndependentData-MonitoringCommittee(IDMC)(DataandSafetyMonitoringBoard,MonitoringCommittee,DataMonitoringCommittee)獨(dú)立的數(shù)據(jù)監(jiān)察委員會(huì)(IDMC)(數(shù)據(jù)和安全監(jiān)察委員會(huì),監(jiān)察委員會(huì),數(shù)據(jù)監(jiān)察委員會(huì))Anindependentdata-monitoringcommitteethatmaybeestablishedbythesponsortoassessatintervalstheprogressofaclinicaltrial,thesafetydata,andthecriticalefficacyendpoints,andtorecommendtothesponsorwhethertocontinue,modify,orstopatrial.由申辦者設(shè)立一個(gè)獨(dú)立的數(shù)據(jù)監(jiān)察委員會(huì),它定期對(duì)研究進(jìn)展、安全性數(shù)據(jù)和有效性終點(diǎn)進(jìn)行評(píng)估,向申辦者建議是否繼續(xù)、調(diào)整或停止試驗(yàn)。1.26ImpartialWitness公平的見證人Aperson,whoisindependentofthetrial,whocannotbeunfairlyinfluencedbypeopleinvolvedwiththetrial,whoattendstheinformedconsentprocessifthesubjectorthesubject’slegallyacceptablerepresentativecannotread,andwhoreadstheinformedconsentformandanyotherwritteninformationsuppliedtothesubject.獨(dú)立與臨床試驗(yàn)、不受與試驗(yàn)有關(guān)人員的不公正影響的個(gè)人。如果對(duì)象或?qū)ο蟮暮戏ń邮艽砣瞬荒荛喿x,他/她將參與知情同意過程,并向?qū)ο箝喿x提供給她們的知情同意書和其他書面資料。1.27IndependentEthicsCommittee(IEC)獨(dú)立的倫理委員會(huì)(IEC)Anindependentbody(areviewboardoracommittee,institutional,regional,national,orsupranational),constitutedofmedicalprofessionalsandnon-medicalmembers,whoseresponsibilityitistoensuretheprotectionoftherights,safetyandwell-beingofhumansubjectsinvolvedinatrialandtoprovidepublicassuranceofthatprotection,by,amongotherthings,reviewingandapproving/providingfavourableopinionon,thetrialprotocol,thesuitabilityoftheinvestigator(s),facilities,andthemethodsandmaterialtobeusedinobtaininganddocumentinginformedconsentofthetrialsubjects.一個(gè)由醫(yī)學(xué)專業(yè)人員和非醫(yī)學(xué)專業(yè)人員組成的獨(dú)立機(jī)構(gòu)(研究機(jī)構(gòu)的、地區(qū)的、國家的或超國家的審評(píng)機(jī)構(gòu)或委員會(huì)),其職責(zé)是保證參加試驗(yàn)對(duì)象的權(quán)益、安全性和健康;并通過對(duì)試驗(yàn)方案、研究人員、設(shè)施以及用于獲得和記錄試驗(yàn)對(duì)象知情同意的方法和材料的合理性進(jìn)行審評(píng)和批準(zhǔn)/提供起促進(jìn)作用的意見以對(duì)這種保護(hù)提供公眾保證Thelegalstatus,composition,function,operationsandregulatoryrequirementspertainingtoIndependentEthicsCommitteesmaydifferamongcountries,butshouldallowtheIndependentEthicsCommitteetoactinagreementwithGCPasdescribedinthisguideline.在不同的國家,獨(dú)立的倫理委員會(huì)的法律地位、組成、職責(zé)、操作和適用的管理要求可能不用,但是應(yīng)當(dāng)如本指導(dǎo)原則所述,允許獨(dú)立的倫理委員會(huì)按GCP進(jìn)行工作。1.28InformedConsent知情同意Aprocessbywhichasubjectvoluntarilyconfirmshisorherwillingnesstoparticipateinaparticulartrial,afterhavingbeeninformedofallaspectsofthetrialthatarerelevanttothesubject'sdecisiontoparticipate.Informedconsentisdocumentedbymeansofawritten,signedanddatedinformedconsentform.一個(gè)對(duì)象在被告知與其作出決定有關(guān)的所有試驗(yàn)信息后,資源確認(rèn)他或她參加一個(gè)特定試驗(yàn)的意愿過程。知情同意采用書面的、簽字并注明日期的知情同意書。1.29Inspection視察Theactbyaregulatoryauthority(ies)ofconductinganofficialreviewofdocuments,facilities,records,andanyotherresourcesthataredeemedbytheauthority(ies)toberelatedtotheclinicaltrialandthatmaybelocatedatthesiteofthetrial,atthesponsor'sand/orcontractresearchorganization’s(CRO’s)facilities,oratotherestablishmentsdeemedappropriatebytheregulatoryauthority(ies).管理當(dāng)局在試驗(yàn)單位、申辦者和/或合同研究組織或管理當(dāng)局認(rèn)為何時(shí)的其他機(jī)構(gòu)對(duì)其認(rèn)為與臨床試驗(yàn)有關(guān)的文件、設(shè)備、記錄和其他資源進(jìn)行的官方審查的活動(dòng)。1.30Institution(medical)(醫(yī)學(xué))研究機(jī)構(gòu)Anypublicorprivateentityoragencyormedicalordentalfacilitywhereclinicaltrialsareconducted.實(shí)施臨床試驗(yàn)任何或私人的實(shí)體、代理機(jī)構(gòu)、醫(yī)學(xué)或齒科設(shè)施。1.31InstitutionalReviewBoard(IRB)機(jī)構(gòu)審評(píng)委員會(huì)(IRB)Anindependentbodyconstitutedofmedical,scientific,andnon-scientificmembers,whoseresponsibilityistoensuretheprotectionoftherights,safetyandwell-beingofhumansubjectsinvolvedinatrialby,amongotherthings,reviewing,approving,andprovidingcontinuingreviewoftrialprotocolandamendmentsandofthemethodsandmaterialtobeusedinobtaininganddocumentinginformedconsentofthetrialsubjects.由醫(yī)學(xué)、科學(xué)和非科學(xué)成員組成的一個(gè)獨(dú)立機(jī)構(gòu),其職責(zé)是通過對(duì)試驗(yàn)方案及其修訂本,獲得受試對(duì)象知情同意所用的方法和資料進(jìn)行審評(píng)、批準(zhǔn)和繼續(xù)審評(píng),確保一項(xiàng)試驗(yàn)的受試對(duì)象的權(quán)利、安全和健康得到保護(hù)。1.32InterimClinicalTrial/StudyReport臨床試驗(yàn)/研究中期報(bào)告Areportofintermediateresultsandtheirevaluationbasedonanalysesperformedduringthecourseofatrial.根據(jù)試驗(yàn)進(jìn)行過程中所做的分析寫出的中期結(jié)果和評(píng)價(jià)的報(bào)告1.33InvestigationalProduct試驗(yàn)用藥品Apharmaceuticalformofanactiveingredientorplacebobeingtestedorusedasareferenceinaclinicaltrial,includingaproductwithamarketingauthorizationwhenusedorassembled(formulatedorpackaged)inawaydifferentfromtheapprovedform,orwhenusedforanunapprovedindication,orwhenusedtogainfurtherinformationaboutanapproveduse.一種在臨床試驗(yàn)中供試驗(yàn)的或作為對(duì)照的活性成分或安慰劑的藥物制劑。包括一個(gè)已上市藥品以不同于所批準(zhǔn)的方式適用或組合(制劑或包裝),或用于一個(gè)未經(jīng)批準(zhǔn)的適應(yīng)證,或用于收集一個(gè)已批準(zhǔn)用法的更多資料。1.34Investigator研究者Apersonresponsiblefortheconductoftheclinicaltrialatatrialsite.Ifatrialisconductedbyateamofindividualsatatrialsite,theinvestigatoristheresponsibleleaderoftheteamandmaybecalledtheprincipalinvestigator.SeealsoSubinvestigator.負(fù)責(zé)在一個(gè)試驗(yàn)單位實(shí)施臨床試驗(yàn)的人。如果在一個(gè)試驗(yàn)單位是由一組人員實(shí)施試驗(yàn),研究者指這個(gè)組的負(fù)責(zé)人,也稱為主要研究者。見次級(jí)研究人員。1.35Investigator/Institution研究者/研究機(jī)構(gòu)Anexpressionmeaning"theinvestigatorand/orinstitution,whererequiredbytheapplicableregulatoryrequirements".表示“符合適用管理要求的研究者和/或研究機(jī)構(gòu)”1.36Investigator'sBrochure研究者手冊(cè)Acompilationoftheclinicalandnonclinicaldataontheinvestigationalproduct(s)whichisrelevanttothestudyoftheinvestigationalproduct(s)inhumansubjects(see7.Investigator’sBrochure).與試驗(yàn)藥品在人類對(duì)象中的研究有關(guān)的臨床和非臨床資料的匯編(見7.研究者手冊(cè))1.37LegallyAcceptableRepresentative法律上可接受的代表Anindividualorjuridicalorotherbodyauthorizedunderapplicablelawtoconsent,onbehalfofaprospectivesubject,tothesubject'sparticipationintheclinicaltrial.在適用法律下被授權(quán)代表一位未來的對(duì)象同意參加臨床試驗(yàn)的個(gè)人,或司法人員或其他機(jī)關(guān)。1.38Monitoring監(jiān)察Theactofoverseeingtheprogressofaclinicaltrial,andofensuringthatitisconducted,recorded,andreportedinaccordancewiththeprotocol,StandardOperatingProcedures(SOPs),GoodClinicalPractice(GCP),andtheapplicableregulatoryrequirement(s).監(jiān)督一個(gè)臨床試驗(yàn)的進(jìn)展,保證臨床試驗(yàn)按照試驗(yàn)方案、標(biāo)準(zhǔn)操作程序(SOP)、臨床試驗(yàn)管理規(guī)范(GCP)和適用的管理要求實(shí)施、記錄和報(bào)告的活動(dòng)。1.39MonitoringReport監(jiān)察報(bào)告Awrittenreportfromthemonitortothesponsoraftereachsitevisitand/orothertrial-relatedcommunicationaccordingtothesponsor’sSOPs.監(jiān)察員在每一次現(xiàn)場(chǎng)訪問和/或其他與試驗(yàn)有關(guān)的交流后,根據(jù)申辦者的SOP寫給申辦者的書面報(bào)告。1.40MulticentreTrial多中心試驗(yàn)Aclinicaltrialconductedaccordingtoasingleprotocolbutatmorethanonesite,andtherefore,carriedoutbymorethanoneinvestigator.按照一個(gè)試驗(yàn)方案,在一個(gè)以上試驗(yàn)單位實(shí)施,因此由一名以上研究者完成的臨床試驗(yàn)。1.41NonclinicalStudy非臨床試驗(yàn)Biomedicalstudiesnotperformedonhumansubjects.不是在人類對(duì)象進(jìn)行的生物醫(yī)學(xué)研究。1.42Opinion(inrelationtoIndependentEthicsCommittee)意見(與獨(dú)立的倫理委員會(huì)相關(guān))Thejudgementand/ortheadviceprovidedbyanIndependentEthicsCommittee(IEC).由獨(dú)立的倫理委員會(huì)(IEC)給出的評(píng)價(jià)和/或建議1.43OriginalMedicalRecord原始醫(yī)學(xué)記錄SeeSourceDocuments.見源文件1.44Protocol試驗(yàn)方案Adocumentthatdescribestheobjective(s),design,methodology,statisticalconsiderations,andorganizationofatrial.Theprotocolusuallyalsogivesthebackgroundandrationaleforthetrial,butthesecouldbeprovidedinotherprotocolreferenceddocuments.ThroughouttheICHGCPGuidelinethetermprotocolreferstoprotocolandprotocolamendments.一個(gè)闡明試驗(yàn)的目的、設(shè)計(jì)、方法學(xué)、統(tǒng)計(jì)學(xué)考慮和組織的文件。試驗(yàn)方案通常也給出試驗(yàn)的背景和理論基礎(chǔ),但者這可以寫在與方案有關(guān)的其他參考文件中。在ICH指導(dǎo)原則中,試驗(yàn)方案這一術(shù)語指試驗(yàn)方案和方案的修改。1.45ProtocolAmendment試驗(yàn)方案的修改Awrittendescriptionofachange(s)toorformalclarificationofaprotocol.對(duì)試驗(yàn)方案的改變或澄清的書面描述。1.46QualityAssurance(QA)質(zhì)量保證(QA)Allthoseplannedandsystematicactionsthatareestablishedtoensurethatthetrialisperformedandthedataaregenerated,documented(recorded),andreportedincompliancewithGoodClinicalPractice(GCP)andtheapplicableregulatoryrequirement(s).為保證試驗(yàn)的進(jìn)行和數(shù)據(jù)產(chǎn)生、記錄以及報(bào)告都符合臨床試驗(yàn)管理規(guī)范(GCP)和適用管理要求所建立的有計(jì)劃的系統(tǒng)活動(dòng)。1.47QualityControl(QC)質(zhì)量控制(QC)Theoperationaltechniquesandactivitiesundertakenwithinthequalityassurancesystemtoverifythattherequirementsforqualityofthetrial-relatedactivitieshavebeenfulfilled.在質(zhì)量保證系統(tǒng)內(nèi)所采取的操作技術(shù)和活動(dòng),以查證與試驗(yàn)相關(guān)的活動(dòng)都符合質(zhì)量要求。1.48Randomization隨機(jī)化Theprocessofassigningtrialsubjectstotreatmentorcontrolgroupsusinganelementofchancetodeterminetheassignmentsinordertoreducebias.為了減少偏倚,采用機(jī)遇決定分配的原理將試驗(yàn)對(duì)象分配倒治療組或?qū)φ战M的過程。1.49RegulatoryAuthorities管理當(dāng)局Bodieshavingthepowertoregulate.IntheICHGCPguidelinetheexpressionRegulatoryAuthoritiesincludestheauthoritiesthatreviewsubmittedclinicaldataandthosethatconductinspections(see1.29).Thesebodiesaresometimesreferredtoascompetentauthorities.有權(quán)進(jìn)行管理的基構(gòu)。在ICHGCP指導(dǎo)原則中,管理當(dāng)局一詞包括審評(píng)所提交的臨床數(shù)據(jù)和實(shí)施視察的機(jī)構(gòu)(見1.29)。這些機(jī)構(gòu)有時(shí)指主管當(dāng)局。1.50SeriousAdverseEvent(SAE)orSeriousAdverseDrugReaction(SeriousADR)嚴(yán)重不良事件(SAE)或嚴(yán)重藥品不良反應(yīng)Anyuntowardmedicaloccurrencethatatanydose:發(fā)生在任何劑量的任何不幸醫(yī)學(xué)事件:●resultsindeath,●-導(dǎo)致死亡●islife-threatening,●-危及生命●requiresinpatienthospitalizationorprolongationofexistinghospitalization,●-需要住院治療或延長住院時(shí)間resultsinpersistentorsignificantdisability/incapacity,or●-導(dǎo)致永久或嚴(yán)重的殘疾/能力喪失,或●isacongenitalanomaly/birthdefect●-先天性異常/出生缺陷(seetheICHGuidelineforClinicalSafetyDataManagement:DefinitionsandStandardsforExpeditedReporting).(見ICH臨床安全性數(shù)據(jù)管理指導(dǎo)原則,快速報(bào)告的定義和標(biāo)準(zhǔn))1.51SourceData源數(shù)據(jù)Allinformationinoriginalrecordsandcertifiedcopiesoforiginalrecordsofclinicalfindings,observations,orotheractivitiesinaclinicaltrialnecessaryforthereconstructionandevaluationofthetrial.Sourcedataarecontainedinsourcedocuments(originalrecordsorcertifiedcopies).臨床試驗(yàn)中的臨床發(fā)現(xiàn)、觀察或其他活動(dòng)的原始記錄及其可靠副本中的全部資料,他們對(duì)于重建和評(píng)價(jià)試驗(yàn)是必要的。源數(shù)據(jù)包含在源文件中(原始記錄或可靠副本)。1.52SourceDocuments源文件Originaldocuments,data,andrecords(e.g.,hospitalrecords,clinicalandofficecharts,laboratorynotes,memoranda,subjects'diariesorevaluationchecklists,pharmacydispensingrecords,recordeddatafromautomatedinstruments,copiesortranscriptionscertifiedafterverificationasbeingaccuratecopies,microfiches,photographicnegatives,microfilmormagneticmedia,x-rays,subjectfiles,andrecordskeptatthepharmacy,atthelaboratoriesandatmedico-technicaldepartmentsinvolvedintheclinicaltrial).原始文件、數(shù)據(jù)和記錄(如醫(yī)院記錄,臨床和辦公室圖標(biāo),實(shí)驗(yàn)室筆記,備忘錄,對(duì)象日記卡或評(píng)價(jià)表,藥房發(fā)藥記錄,自動(dòng)儀器的記錄數(shù)據(jù),在核對(duì)后做為準(zhǔn)確副本的可靠復(fù)印件或抄件,顯微膠片,攝影負(fù)片,縮微膠卷或磁介質(zhì),X線,對(duì)象文件,以及保存在藥房、實(shí)驗(yàn)室和與參與臨床試驗(yàn)的醫(yī)學(xué)技術(shù)部門中的記錄。1.53Sponsor申辦者Anindividual,company,institution,ororganizationwhichtakesresponsibilityfortheinitiation,management,and/orfinancingofaclinicaltrial.對(duì)一個(gè)臨床試驗(yàn)的發(fā)起、管理和/或財(cái)務(wù)負(fù)責(zé)的個(gè)人、公用、機(jī)構(gòu)或組織。1.54Sponsor-Investigator申辦者-研究者Anindividualwhobothinitiatesandconducts,aloneorwithothers,aclinicaltrial,andunderwhoseimmediatedirectiontheinvestigationalproductisadministeredto,dispensedto,orusedbyasubject.Thetermdoesnotincludeanypersonotherthananindividual(e.g.,itdoesnotincludeacorporationoranagency).Theobligationsofasponsor-investigatorincludeboththoseofasponsorandthoseofaninvestigator.單獨(dú)與其他人一起,發(fā)起并實(shí)施一個(gè)臨床試驗(yàn)的個(gè)人。在他(們)的直接指示下,給對(duì)象服用、發(fā)給對(duì)象或由對(duì)象使用試驗(yàn)藥品。該術(shù)語并不包括除了個(gè)人以外的任何人(如不包括一個(gè)公司或一個(gè)機(jī)構(gòu))。一個(gè)申辦者-研究者的義務(wù)包括一個(gè)申辦者和一個(gè)研究者兩者的義務(wù)。1.55StandardOperatingProcedures(SOPs)標(biāo)準(zhǔn)操作程序(SOP)Detailed,writteninstructionstoachieveuniformityoftheperformanceofaspecificfunction.為達(dá)到均一性完成一個(gè)特定職責(zé)指定的詳細(xì)書面說明。1.56Subinvestigator次級(jí)研究人員Anyindividualmemberoftheclinicaltrialteamdesignatedandsupervisedbytheinvestigatoratatrialsitetoperformcriticaltrial-relatedproceduresand/ortomakeimportanttrial-relateddecisions(e.g.,associates,residents,researchfellows).SeealsoInvestigator.在一個(gè)試驗(yàn)單位,在主要研究者指定和監(jiān)督下的臨床試驗(yàn)組中完成與試驗(yàn)有關(guān)的重要程序和/或作出與有關(guān)試驗(yàn)的重大決定的成員(如同事,住院醫(yī)生,特別是研究生)。見研究者。1.57Subject/TrialSubject對(duì)象/試驗(yàn)對(duì)象Anindividualwhoparticipatesinaclinicaltrial,eitherasarecipientoftheinvestigationalproduct(s)orasacontrol.參加一個(gè)臨床試驗(yàn)作為試驗(yàn)藥品的接受者或作為對(duì)照的個(gè)人。1.58SubjectIdentificationCode對(duì)象識(shí)別編碼Auniqueidentifierassignedbytheinvestigatortoeachtrialsubjecttoprotectthesubject'sidentityandusedinlieuofthesubject'snamewhentheinvestigatorreportsadverseeventsand/orothertrialrelateddata.研究者為每一名受試對(duì)象指定的獨(dú)特識(shí)別號(hào)碼,以保護(hù)對(duì)象的身份并在研究者報(bào)告不良事件和/或其他與試驗(yàn)有關(guān)數(shù)據(jù)時(shí)代替對(duì)象姓名。1.59TrialSite試驗(yàn)單位Thelocation(s)wheretrial-relatedactivitiesareactuallyconducted.真正開展與臨床試驗(yàn)有關(guān)活動(dòng)的地方。1.60UnexpectedAdverseDrugReaction非預(yù)期的藥品不良反應(yīng)Anadversereaction,thenatureorseverityofwhichisnotconsistentwiththeapplicableproductinformation(e.g.,Investigator'sBrochureforanunapprovedinvestigationalproductorpackageinsert/summaryofproductcharacteristicsforanapprovedproduct)(seetheICHGuidelineforClinicalSafetyDataManagement:DefinitionsandStandardsforExpeditedReporting).一種不良反應(yīng),其性質(zhì)或嚴(yán)重程度與現(xiàn)有的產(chǎn)品資料(如一種未批準(zhǔn)試驗(yàn)用藥品的研究者手冊(cè),或包裝插入頁/一個(gè)已經(jīng)批準(zhǔn)藥物的產(chǎn)品性能摘要)不符的不良反應(yīng)(見ICH臨床安全性數(shù)據(jù)管理指導(dǎo)原則:快速報(bào)告的定義和標(biāo)準(zhǔn))。1.61VulnerableSubjects弱勢(shì)對(duì)象Individualswhosewillingnesstovolunteerinaclinicaltrialmaybeundulyinfluencedbytheexpectation,whetherjustifiedornot,ofbenefitsassociatedwithparticipation,orofaretaliatoryresponsefromseniormembersofahierarchyincaseofrefusaltoparticipate.Examplesaremembersofagroupwithahierarchicalstructure,suchasmedical,pharmacy,dental,andnursingstudents,subordinatehospitalandlaboratorypersonnel,employeesofthepharmaceuticalindustry,membersofthearmedforces,andpersonskeptindetention.Othervulnerablesubjectsincludepatientswithincurablediseases,personsinnursinghomes,unemployedorimpoverishedpersons,patientsinemergencysituations,ethnicminoritygroups,homelesspersons,nomads,refugees,minors,andthoseincapableofgivingconsent.指受到不正當(dāng)?shù)挠绊懚Q為一個(gè)臨床志愿者的人,他們可能由于期望(無論正當(dāng)與否)參加試驗(yàn)而伴隨的利益,或者拒絕參加會(huì)受到等級(jí)中資深成員的報(bào)復(fù)。有等級(jí)結(jié)構(gòu)的團(tuán)體的成員,如醫(yī)學(xué)、藥學(xué)、齒科或護(hù)理專業(yè)的學(xué)生,附屬醫(yī)院和實(shí)驗(yàn)室人員,制藥公司的雇員,軍人,以及被監(jiān)禁的人。其他弱勢(shì)對(duì)象包括無可救藥的患者,住在福利院利的人,失業(yè)者或窮人,處于危急狀況的病人,少數(shù)民族,無家可歸者,流浪者,未成年者,和那些無能力給出知情同意的人1.62Well-being(ofthetrialsubjects)健康(試驗(yàn)對(duì)象的)Thephysicalandmentalintegrityofthesubjectsparticipatinginaclinicaltrial.參加臨床試驗(yàn)對(duì)象的體格和精神的完整性。2.THEPRINCIPLESOFICHGCPICH-GCP的原則2.1ClinicaltrialsshouldbeconductedinaccordancewiththeethicalprinciplesthathavetheiroriginintheDeclarationofHelsinki,andthatareconsistentwithGCPandtheapplicableregulatoryrequirement(s).2.1臨床試驗(yàn)的實(shí)施應(yīng)符合源自赫爾辛基宣言的倫理原則,與GCP和適用管理要求一致。2.2Beforeatrialisinitiated,foreseeablerisksandinconveniencesshouldbeweighedagainsttheanticipatedbenefitfortheindividualtrialsubjectandsociety.Atrialshouldbeinitiatedandcontinuedonlyiftheanticipatedbenefitsjustifytherisks.2.2在開始一個(gè)試驗(yàn)之前,應(yīng)當(dāng)權(quán)衡個(gè)體試驗(yàn)對(duì)象和社會(huì)的可預(yù)見風(fēng)險(xiǎn)、不方便和預(yù)期的受益。只有當(dāng)預(yù)期的受益大于風(fēng)險(xiǎn)時(shí),才開始和繼續(xù)一個(gè)臨床試驗(yàn)。2.3Therights,safety,andwell-beingofthetrialsubjectsarethemostimportantconsiderationsandshouldprevailoverinterestsofscienceandsociety.2.3試驗(yàn)對(duì)象的權(quán)利、安全和健康是最重要的考慮,應(yīng)當(dāng)勝過科學(xué)和社會(huì)的利益。2.4Theavailablenonclinicalandclinicalinformationonaninvestigationalproductshouldbeadequatetosupporttheproposedclinicaltrial.2.4關(guān)于試驗(yàn)用藥品可得到的非臨床和臨床資料應(yīng)足以支持所提議的臨床試驗(yàn)。2.5Clinicaltrialsshouldbescientificallysound,anddescribedinaclear,detailedprotocol.2.5臨床試驗(yàn)應(yīng)當(dāng)有堅(jiān)實(shí)的科學(xué)基礎(chǔ),有明確、詳細(xì)描述的試驗(yàn)方案。2.6Atrialshouldbeconductedincompliancewiththeprotocolthathasreceivedpriorinstitutionalreviewboard(IRB)/independentethicscommittee(IEC)approval/favourableopinion.2.6臨床試驗(yàn)的實(shí)施應(yīng)當(dāng)遵循事先已經(jīng)得到研究機(jī)構(gòu)審查委員會(huì)(IRB)/獨(dú)立的倫理委員會(huì)(IEC)批準(zhǔn)/贊成的試驗(yàn)方案。2.7Themedicalcaregivento,andmedicaldecisionsmadeonbehalfof,subjectsshouldalwaysbetheresponsibilityofaqualifiedphysicianor,whenappropriate,ofaqualifieddentist.2.7一名合格醫(yī)生或合格牙醫(yī)的職責(zé)永遠(yuǎn)是給予對(duì)象醫(yī)療保健,代表對(duì)象作出醫(yī)學(xué)決定。2.8Eachindividualinvolvedinconductingatrialshouldbequalifiedbyeducation,training,andexperiencetoperformhisorherrespectivetask(s).2.8參與實(shí)施臨床試驗(yàn)個(gè)每一個(gè)人應(yīng)當(dāng)在受教育、培訓(xùn)和經(jīng)驗(yàn)方面都有資格完成他或她的預(yù)期任務(wù)。2.9Freelygiveninformedconsentshouldbeobtainedfromeverysubjectpriortoclinicaltrialparticipation.2.9應(yīng)當(dāng)在參加臨床試驗(yàn)前每一個(gè)對(duì)象獲得自由給出的知情同意書。2.10Allclinicaltrialinformationshouldberecorded,handled,andstoredinawaythatallowsitsaccuratereporting,interpretationandverification.2.10所有臨床試驗(yàn)資料被記錄、處理和儲(chǔ)存的方式應(yīng)當(dāng)允許資料的準(zhǔn)確報(bào)告、解釋和核對(duì)。2.11Theconfidentialityofrecordsthatcouldidentifysubjectsshouldbeprotected,respectingtheprivacyandconfidentialityrulesinaccordancewiththeapplicableregulatoryrequirement(s).2.11可能鑒別對(duì)象身份的記錄的保密性應(yīng)當(dāng)?shù)玫奖Ｗo(hù),依照適用的管理要求尊重隱私和保密規(guī)定。2.12Investigationalproductsshouldbemanufactured,handled,andstoredinaccordancewithapplicablegoodmanufacturingpractice(GMP).Theyshouldbeusedinaccordancewiththeapprovedprotocol.2.12試驗(yàn)用藥品應(yīng)當(dāng)按照適用的藥品生產(chǎn)質(zhì)量管理規(guī)范(GMP)生產(chǎn)、處理和儲(chǔ)存。試驗(yàn)用藥品應(yīng)按照已批準(zhǔn)的方案使用。2.13Systemswithproceduresthatassurethequalityofeveryaspectofthetrialshouldbeimplemented.2.13應(yīng)當(dāng)建立保證試驗(yàn)各方面質(zhì)量的程序系統(tǒng)。3.INSTITUTIONALREVIEWBOARD/INDEPENDENTETHICSCOMMITTEE(IRB/IEC)機(jī)構(gòu)審查委員會(huì)/獨(dú)立的倫理委員會(huì)3.1Responsibilities職責(zé)3.1.1AnIRB/IECshouldsafeguardtherights,safety,andwell-beingofalltrialsubjects.Specialattentionshouldbepaidtotrialsthatmayincludevulnerablesubjects.3.1.1IRB/IEC應(yīng)當(dāng)保護(hù)所有試驗(yàn)對(duì)象的權(quán)利、安全和健康。應(yīng)當(dāng)特別注意那些可能包括有弱勢(shì)對(duì)象的試驗(yàn)。3.1.2TheIRB/IECshouldobtainthefollowingdocuments:3.1.2IRB/IEC應(yīng)當(dāng)?shù)玫揭韵挛募?trialprotocol(s)/amendment(s),writteninformedconsentform(s)andconsentformupdatesthatthe