醫(yī)院實施臨床試驗合約書(中英文)

HUMANCLINICALTRIALAGREEMENTWITHHOSPITALThisAgreementismadebetweenHospital(hereinafter“PartyA”)andthetrialsponsor(hereinafter“PartyB”).(PartyB'sName)hasanofficeinandisgovernedbythelawsoftheRepublicofChina.PartyAisamedicalinstitutionsituatedinTaipeiCity,Taiwan,theRepublicofChinaandisgovernedbythelawsoftheRepublicofChina.此合約是由臺北市醫(yī)院委托財團法人私立臺北醫(yī)學大學(以下簡稱“甲方”)，以及試驗委托者(以下簡稱“乙方”)雙方所簽訂。PartyAacceptsPartyB'srequesttoimplementtheclinicaltrialprotocolnamed“ProtocolName”.(ProtocolNumber:.PrincipleInvestigator:Dr..ExpectedCommencementandEndDatesoftheTrial:).甲方接受乙方委托，實施臨床試9。(試驗編號：。試驗主持人：=。試驗預計起迄期間：—)。ThePartiesagreetothefollowingtermsandconditions:特立約遵照條款如下：Undertaking聲明PartyB(includingthedelegatedtrialinstitutionsub-delegatedbyPartyB)shallmakereasonableeffortstoprovideacompleteclinicaltrialprojectbasedonthedateandtitleoftheclinicaltrialprotocolandinaccordancewiththe“GoodClinicalPractice).AcopyoftheClinicalTrialProtocol(Attachment1)isattachedtothisAgreementforreference.Thecontentsoftheclinicaltrialshallbeguidedbythe[PrincipleInvestigator],whoshallbethe“PrincipleInvestigator”asagreedunderthisAgreement.IncaseofanydiscrepancybetweenthisAgreementandtheClinicalTrialProtocol,thisAgreementshallprevail.TheClinicalTrialProtocolcanonlybeamendedafterpriorwrittenagreementsbybothParties.乙方(及乙方復委托之受托研究機構(gòu))應合理盡力的依照優(yōu)良臨床試驗各項相關(guān)規(guī)范及準則于期間內(nèi)執(zhí)行并完成試驗。試驗內(nèi)容應接受試驗主持人____之指導，即本合約中所同意的"主要試驗主持人。若在本合約及計劃書中發(fā)生任何不一致時，以本合約內(nèi)容為準。計劃書只有在事先經(jīng)由甲乙雙方書面同意后才可進行更動。ImplementationPeriod執(zhí)行期間InaccordancewiththisAgreement,unlessthescopeofthisAgreementisextendedbyamendment,orthisAgreementisterminatedinaccordancewithArticle14,theimplementationperiodoftheclinicaltrialshallbefrom(CommencementDate)to(EndDate).ThisclinicaltrialshallonlybeimplementedaftertheapprovalfromPartyA'sInstitutionalReviewBoard(“IRB”)and/ortheapprovalfromtheDepartmentofHealthoftheExecutiveYuan.根據(jù)本合約，除非因本合約修正而擴大，或因第14條而終止，本合約有效期間應為開始日期至結(jié)束日期。此試驗將依據(jù)現(xiàn)行法規(guī)于收到甲方之人體試驗委員會("IRB”)同意及/或行政院衛(wèi)生署通過后才開始執(zhí)行。Fees費用PartyBshallpaytoPartyAthebudgedfeesunderAttachment2.BasedonbothParties'estimates,theamountofthebudgetwillbesufficientforthisclinicaltrial.However,PartyAmayreasonablyincurfeesexceedingthebudget,inwhichcasePartyAshallsubmitaMemorandumofUnderstandingforthepurposeofamendingandincreasingthebudget.UnlessotherwisestipulatedunderthisAgreement,PartyBshallnotbeobligedtopayanyfeeexceedingbudgetwhichhasnotbeenpreviouslyapprovedbyawrittenMemorandumofUnderstanding.乙方應根據(jù)附件二中列出的預算支付費用給甲方。由各方估算，預算規(guī)定的金額將足以支付此試驗，但甲方可合理的預期超支的費用，則甲方需提交一份備忘錄以要求修訂增加的預算。除非本合約另有規(guī)定，否則乙方不必支付任何未經(jīng)事先以書面?zhèn)渫浐藴实某ьA算。ThetotalresearchbudgetisNewTaiwanDollars(NT$)includingtax.PartyBmaychoosetopaythefullamounttoPartyAuponsignatureofthisAgreement.FollowingnegotiationbybetweentheParties,PartyAmaydisposeofthisamountatitsowndiscretion.TheamountmaybeincreasedordecreasedbasedonactualneedsfollowingnegotiationsbetweentheParties.PartyBmayalsochoosetomakethepaymentsinaccordancewiththefollowingbasedonactualneeds.研究經(jīng)費合計新臺幣元整含稅。乙方可選擇于合約簽訂后全額匯款付予甲方，甲方可經(jīng)由雙方協(xié)商后全權(quán)支配此經(jīng)費，并得視實際需求經(jīng)雙方議定后增減之?；蛞曳娇梢晫嶋H需求選擇下列支付方式。WithinoneweekfromsigningthisAgreement,PartyBshallpaytoPartyAone-thirdofthetotalamountoftheExpense-BasedCostslistedinAttachment2一ClinicalTrialBudgetTable一aswellastheMedicalManagementFees,totalingNewTaiwanDollars(NT$).UnlessstipulatedinthisAgreementwithregardtobudget,thefeesshallbepaidinfullwithinthirty(30)daysfromthedateofthisAgreement.乙方應根據(jù)附件二臨床試驗預算表中「消耗費用」總金額，于合約簽訂后一周內(nèi)先撥三分之一經(jīng)費，并同藥品管理費，共計新臺幣元整，付予甲方，且除本合約另有預算規(guī)定外，應于合約日期的三十(30)天之內(nèi)繳納費用。Followingthecommencementofthetrial,variousExpense-BasedCostsincurred,theEmployeeSalaryExpensesandotherrelatedexpensesshallbecalculatedandpaidatonceonaquarterlybasisbasedonactualconsumptionandpaymentsituationsinaccordaneewithAttachment2一ClinicalTrialBudgetTableandEmployeeSalaryExpensesSchedule.PartyBunderstandsandagreesthatthesubmissionfeebyPartyA'sInstitutionalReviewBoardcannotbereimbursed,whetherithasbeenincludedinthebudgetornot.PartyBchoosestopaythefeesby:installmentpayment/fullpayment.試驗開始后，所產(chǎn)生之各項消耗費用，研究護士工資及其它相關(guān)費用，將依據(jù)附件二臨床試驗預算表與研究護士工資付款期程表，依實際消耗支付狀況，以每季結(jié)算一次方式給付之。無論是否被納入預算，乙方都了解并同意支付甲方之人體試驗委員會審查費用是不可退還的。乙方選擇經(jīng)費撥付方式為：。(全額匯款或分撥匯款)FeestobepaidtoPartyAshallbewiredintothefollowingbankaccount:ChinaTrustCommercialBankTunNanBranch163538122106AccountName“TaipeiMedicalUniversity-MunicipalWanFangHospital"Inordertoconfirmtheamountwired,eachpaymentshallbeaccompaniedbythenameofthepayinginstitutionandthenameofthemaininvestigatorofthetrial.應支付給甲方之費用，將匯入下列賬戶：為確認款項，每次的支付應注明簽賬單位名稱以及主要試驗主持人的姓名。4.Supply供應PartyBshallsupplyPartyA,freeofcharge,withsufficientvolumesofinvestigationalproducts(orequipment)inordertoimplementtheclinicaltrial.Itshallalsoprovideothercompoundsubstances,rawmaterials,instruments,equipmentandinformationthataredesignatedinotherprotocolsorthosedeemednecessarybyPartyB.Unlessotherwisestipulated,theownershipofallsuchinvestigationalproducts(orequipment),compoundedsubstances,rawmaterials,instrumentsandequipmentshallbelongtoPartyB.Suchinvestigationalproducts(orequipment)shallbelimitedtobeusedonsubjectsofthisClinicalTrialProtocolbyPartyA's(human)principleinvestigatorandshallnotbeusedforanyotherpurposes.乙方應免費提供甲方足夠量的研究用產(chǎn)品、耗材、儀器設(shè)備以及信息以進行臨床試驗。除非另有規(guī)定，上述物品及信息之所有權(quán)仍歸于乙方。本試驗之研究用產(chǎn)品限于甲方之試驗主持人使用于本試驗之受試者，不得他用。PrincipleInvestigator'sUndertaking試驗主持人的保證PartyA'sprincipleinvestigatorguaranteestoundertakeallrelevantobligationsrequiredundertheprovisionsoftheClinicalTrialProject(Attachment1)andtocomplywithappropriategovernmentlawsandregulations.PartyBundertakestocomplywithandtoperformtherelevantrequirementsbytheinvestigatorandbytheDepartmentofHealthoftheExecutiveYuanundertheprovisionsoftheClinicalTrialProtocol(Attachment1).甲方之試驗主持人承諾負擔本試驗計劃書(附件一)條款中所要求的相應義務，并符合適當?shù)恼ㄒ?guī)。乙方承諾遵守并履行本試驗計劃書(附件一)條款中，試驗主持人及行政院衛(wèi)生署所要求的相關(guān)規(guī)定。Notice通知AnynoticeorrequestinrelationtothisAgreementshallbedoneinwritingandshallbemailedorfaxedtothefollowingaddressesbyexpresspre-paidcourier:任何與本合約有關(guān)的通知或要求，都應以書面、快遞郵件、已付郵資的方式郵寄到：IndependentContractor獨立簽約者PartyAisanindependentcontractorandisnotanagent,partner,orasponsor.該甲方是一個獨立的簽約者，而非乙方的代理人、合伙人或贊助者。IndependentClinicalTrial獨立臨床試驗Whethertheemployeesreceiveasalaryornot,thisAgreementmaynotbeconstruedtorestrictthefreedomoftheinvestigatorsandPartyA'semployeestoengageinothersimilarcasesoutsidethisAgreementandforentitiesotherthanPartyB.無論人員受薪與否，本合約均不得被解釋為可限制試驗主持人及甲方中的雇員去從事非本合約、乙方以外之團體，所進行之其它類似案件之自由。Confidentiality保密資料Allinformationwhichhasbeendesignatedasconfidentialshallbe,priortotheirpublicdivulgation,deemedasconfidentialinformationinthemannerofwrittenconfidentialityundertakings.TheconfidentialinformationmaynotbeusedbyanyotherentityforanypurposeotherthanthisAgreement.UponreceiptofconfidentialinformationprovidedbytheotherParties,eachPartyagreestohandlethemasiftheyareitsownconfidentialinformation,andshallnotdivulgesuchconfidentialinformationtoanythirdpartywithinthree(3)yearsuniesspriorwrittennotificationissenttotheotherParty.Theabovementionedconfidentialityobligationsshallnotapplytothefollowing:Informationofthepublicdomainatthetimeofdivulgation;Informationknowntootherspriortoitsdivulgation;Informationobtainedfromthirdpartywithoutconfidentialityobligations;orDivulgationrequiredbylaws.所有指定需保密的數(shù)據(jù)在其應被公開之時間以前，均應以書面保密協(xié)議之方式被視為機密數(shù)據(jù)，除了此合約所要達成的目的外，不得被其它團體任意使用。甲乙雙方同意當收到由對方提供的機密數(shù)據(jù)時，將視同己方的機密數(shù)據(jù)一樣妥善管理，并進一步同意若沒有事先以書面方式通知對方，將于三(3)年內(nèi)不向第三方揭露這些機密資料。前述的保密義務不適用于：揭露時屬于公共領(lǐng)域；在揭露前已被他人得知；資料來自于對乙方?jīng)]有保密義務的第三方；或被法律要求揭露。DataOwnershipandIntellectualPropertyRights數(shù)據(jù)的所有權(quán)及智能財產(chǎn)權(quán)(a)PartyBshallretainownershipoverthecasereportforms(CRF)andthedatageneratedastheresultofthepurposeoftheClinicalTrialProtocol.However,PartyAshallretainownershipoverthemedicalhistoryinformationandsourcedata(exceptthedailyrecordofthesubjects).However,PartyAanditsprincipleinvestigatorhavetherighttokeepaphotocopyoftheclinicaltrialdatageneratedastheresultoftheclinicaltrialforeducationaland/oracademicresearchpurposes,anditmaypublicizetheresultsoftheclinicaltrialinaccordancewithArticle11.乙方提供之個案報告表及由本試驗計劃書研究目的而產(chǎn)生的數(shù)據(jù)結(jié)果，其所有權(quán)歸乙方所有。但病歷數(shù)據(jù)及原始文件之所有權(quán)(受試者日志除外)歸屬甲方所有。但甲方及甲方之試驗主持人有權(quán)保留此試驗產(chǎn)生的數(shù)據(jù)結(jié)果復印件以作為教育及/或?qū)W術(shù)探討之用，并可如第十一(11)條所述公開發(fā)表其臨床試驗結(jié)果。(b)UnlessstipulatedinthisAgreement,theintellectualpropertyrightsoftheinventions,discovered,improvementofthetrialcoursesandresults,andthetrialresultsanditsproductsareownedbyPartyB.However,anyinnovativeoperations,therapiesandrelativetomedicaltechnologiesforthisClinicalTrialProtocolresearchedorinventedbyPartyAand/orPartyA'sprincipleinvestigator,thepatentandintellectualpropertyrightsarebelongedtoPartyAanditsprincipleinvestigator.除本合約另有規(guī)定外，試驗過程及結(jié)果之發(fā)明、發(fā)現(xiàn)、改良與研發(fā)成果與產(chǎn)品，其智能財產(chǎn)權(quán)均歸屬乙方所有。但甲方及其試驗主持人，為本計劃案所研發(fā)、創(chuàng)新之手術(shù)治療方式及相關(guān)醫(yī)療技術(shù)，其專利權(quán)及智慧財產(chǎn)權(quán)仍歸甲方及其試驗主持人所有。Excepttheabove-mentioned(a)and(b),intheeventthattheinvestigationalproducts(orequipment)usedbyPartyAinthetrialandthosepropertyrights/orintellectualpropertyrightsbelongtoPartyAoranythirdparty,PartyAshallnotifyPartyBinwritingpriorusingthem,butthosepropertyrightsand/orintellectualpropertyrightsstillbelongtooriginalowners.除前二項規(guī)定外，甲方于試驗中如有使用原甲方所有或第三人所有之所有權(quán)及/或智能財產(chǎn)權(quán)，應于使用前以書面通知乙方，惟其所有權(quán)及/或智慧財產(chǎn)權(quán)仍歸屬各該原權(quán)利人所有。SpecimenOwnership檢體的所有權(quán)Ifspecimenscollectedfortheclinicaltrialareusedbyothersubsequentadditionalexperiments,eachPartyagreesthefollowings:(a)AccordingtothestipulationprovidedbyDepartmentofHealth,ExecutiveYuan,R.O.C.,itshallbemadestatementintheInformedConsentFormthatspecimenssuppliedbythesubjectsofthisclinicaltrialwillbeusedbyothersubsequentadditionalexperimentsforotherpurposes.(b)complyingwithRegulationsforcollectingandusingofhumansforresearchthatprovidedbyDepartmentofHealth,ExecutiveYuan,R.O.C.InformationofthesubjectsshallbekeptconfidentialandshallbeprotectedinaccordancewiththeprovisionsoftheInformedConsentFormandrelevantlaws.若試驗所采集的檢體樣本會在后續(xù)進行其它附加研究，甲乙雙方同意以下所有的事項：(1)依據(jù)行政院衛(wèi)生署相關(guān)規(guī)定于受試者同意書中說明此試驗受試者提供之檢體樣本將會進行后續(xù)其它的目的。(2)遵守行政院衛(wèi)生署「研究用人體檢體采集及使用注意事項之規(guī)定。(3)受試者的資料將保密并受到受試者同意書中的規(guī)定及相關(guān)法律所保護。Publication公布出版PartyBunderstandsthatPartyAisfocusedontheexchangeofmedicalandacademicinformationandmaypublicizetheresultsofitsacademicactivities.Thus,PartyAhastherighttopublicizeinformationthatisrelatedtothisclinicaltrialverballyorinwriting.ForPartyA'spublicationordisclosureoftheserelatedinformation,awrittenphotocopyshallbeprovidedbyPartyBthirty(30)dayspriortothepublicationordisclosure.Ifthepublicationordisclosureofinformationinvolvespatentsorotherconfidentialinformation,theconfidentialinformationshallbeprotected.DuringPartyB'sreviewofwritteninformationwithinthethirty(30)dayperiod,PartyAmaydelayitspublicationordisclosureofrelatedinformationforamaximumofsixty(60)daysinorderforPartyBorPartyAtofileapatentapplication.乙方明了甲方乃致力于醫(yī)療學術(shù)交流并會公開傳播其學術(shù)活動的成果。因此，甲方有權(quán)以口頭或是書面方式發(fā)表與此試驗相關(guān)的數(shù)據(jù)。甲方在出版或發(fā)表這些相關(guān)資料時，應于三十(30)天前提交一份書面的復印件給乙方。當這些資料被出版或發(fā)表時，若涉及專利或其它機密數(shù)據(jù)，則這些機密數(shù)據(jù)應被保護。甲方在乙方審查這些書面資料的三十(30)天期間，將最多可延遲六十(60)天來出版或發(fā)布相關(guān)資料，以使乙方或甲方能提出專利申請。Ifthisisamulti-agencyclinicaltrialproject,thenPartyAagreesnottopublicizeanyincompleteresultspriortothecompletionofthetrialorpriortoresultsofPartyB'sanalysis.Afterpublicationofthemulti-agencytrialresults,oriftheresultsarenotpublicizedaftertwelve(12)monthsfollowingthefullcompletionofthemulti-agencytrial,PartyAhastherighttopublicizeitsindividualclinicaltrialresultsaftersendingtheinformationforPartyB'sreviewandconfirmationthirty(30)dayspriortothepublication.However,iftheinvestigatordeemsthatthepublicationofthetrialresultsshouldnotbedelayedforpublichealth,safetyorbenefitreasons,thedelayedpublicationoftwelve(12)monthsshallbeexempt.如果這是一個多中心的臨床試驗計劃，則甲方同意不會在試驗結(jié)束前或乙方分析結(jié)果出來前發(fā)表任何不完整的成果。在多中心試驗結(jié)果已被公開，或當多中心試驗全部結(jié)束后十二(12)個月結(jié)果仍未被公開時，甲方有權(quán)在三十(30)天前將資料送交乙方審查無誤后，發(fā)布個別的試驗成果。然而，當試驗主持人認為出于公共衛(wèi)生、安全、或福利的原因，此試驗成果的發(fā)布不應被延遲時，此十二(12)個月的發(fā)布延遲應被免除。SiteEntry場所的進入InaccordancewiththelawsandregulationsoftheDepartmentofHealthoftheExecutiveYuan,whenPartyBortheDepartmentofHealthrequirescontactwiththeinvestigator,otherpersonnelorequipmentrelatedtothisclinicaltrial,medicalrecords,recordsofthesubjects,individualcasereporttablesandotherrecordswhicharedirectlyrelatedtothisclinicaltrialinaccordancewithrelevantlawsandregulations,itshalldosoduringnormalbusinesshourswithpriornotice.當乙方(及乙方復委托之受托研究機構(gòu))或衛(wèi)生主管機關(guān)需要與甲方之試驗主持人及其它與此試驗相關(guān)的人員接觸以進行監(jiān)測或稽核時，應在平常的上班時間內(nèi)進行，并事先告知。Promotion宣傳Withoutpriorwrittenconsent,neitherPartymaypromoteoradvertisetheproductsrelatedtothisclinicaltrial.However,thisdoesnotincludepre-existingrequirementsincludedintheattachmenttothisAgreement(suchasrecruitmentadvertisingforsubjectsapprovedbytheIRB).如無事先的書面許可，任一方不得隨意進行與此試驗相關(guān)的產(chǎn)品推廣及廣告。但這其中不包括此合約附件中已存在的要求(例如經(jīng)由甲方之人體試驗委員會核準之受試者招募廣告)。Termination終止ThisAgreementmaybeterminatedbyeitherPartywithanyreason,withasimplethirty(30)daypriorwrittennoticetotheotherParty.IfbasedonPartyA'sorPartyB'sevaluation,oriftheinvestigator,PartyA'sIRBortheDepartmentofHealthoftheExecutiveYuanconsidersthatthisclinicaltrialisinappropriate,unrealisticorunsuitabletobecontinued,thisclinicaltrialmaybeterminatedbyPartyAorPartyBatanytimeforanyreason.UponterminationofthisAgreement,PartyAshallbecompensatedforreasonableexpensesincurredpriortotheterminationofthisAgreementandfeeswhichcannotbecanceledandwhichhavenotbeenpaid.此合約可能由任一方因任何理由提出終止，惟需于三十(30)天前以書面方式告知另一方。當甲方或乙方在評估之后，或甲方之試驗主持人、甲方之人體試驗委員會、或衛(wèi)生主管機關(guān)認為此試驗不宜進行時，此試驗可在任何時間及任何理由下由甲乙任一方徑行終止。合約終止時，對于本合約終止之前已發(fā)生之合理支出及無法取消的一些未付清的費用，甲方應得到賠償。UponterminationofthisAgreementorwhenPartyAreceivesthenoticefortheterminationofthisAgreement,PartyAshallreturntoPartyBallfeeswhichPartyBhasoverpaidpriortotheterminationofthisAgreement.Ifasubjectterminateshisorherparticipation,orifthetrialisdiscontinuedforanyreason,PartyAshallbeprotectedbytheprincipleofnolosses,andthereforePartyBshallpaytoPartyAexpensesrelatedtothesesubjectsbasedonareasonableproportion,orpayfeestoPartyAinaccordancewiththepaymenttimetablewhichwasalreadyagreedupon.WhenthisAgreementexpiresoristerminatedbyoneorbothPartiesinaccordancewiththisAgreement,bothPartiesshallstarttocomplywithrelevantprovisionswithregardtopost-terminationoftheAgreement.Suchprovisionsshallinclude(butarenotlimitedto)Articles3,5,6,9,10,11,12,15and17.當本合約終止或甲方收到?jīng)Q定終止的通知時，甲方應將合約終止之前乙方所給付的超額費用退還給乙方。若受試者中止其參與，或試驗因任何原因不再繼續(xù)時，甲方應受到無損失原則的保護，故乙方應按合理的支付甲方已發(fā)生之受試者費用及相關(guān)試驗消費。當本合約期滿或因第14條規(guī)定而終止時，甲乙雙方仍應遵循本合約包括(但不僅限于)第3,5,6,9,10,11,12,15及17條款等內(nèi)容。Indemnification賠償PartyB(includingthedelegatedtrialinstitutionsub-delegatedbyPartyB)shallcompensate,holdharmlessandprotectPartyAanditsagents,representatives,contractors,officersandemployees(the“Indemnified”)fromanydamagesfromdemands,suits,claims,declarationsorreimbursements(includingreasonableattorneys'feesandotherfeesincurredforthedefense)forpersonalinjuries(includingbutnotlimitedtodeath)orpropertydamagesarisingoutoforrelatedtotheimplementationofthisclinicaltrial.PartyAagreestoreasonablyprovidePartyBwithnecessaryassistancetoproceedwithnegotiations,settlementsanddefenseswiththirdparties.PartyBunderstandsandagreesthatthesubjects(includingtheirlegalsuccessorsandotherlegalclaimants)haveadirectrightofclaimagainstPartyB(includingthedelegatedtrialinstitutionsub-delegatedbyPartyB).乙方(及乙方復委托之受托研究機構(gòu))應采取積極措施保護甲方及其參與試驗人員免于遭受傷害(包括但不限于身體或財物)并賠償所受之一切損害，包括遭提出之任何要求訴訟、宣告、清償及合理之律師費及其它因辯護產(chǎn)生的費用。甲方同意提供乙方合理之必要協(xié)助，與該第三人進行談判、和解及提出抗辯等。PartyBisnotresponsibleforlossesordamagesincurredbyPartyAfor(1)failuretocomplywithrelevantprovisionsoftheClinicalTrialProtocoland(2)failuretocomplywithprovisionsrequiredbytheDepartmentofHealthoftheExecutiveYuanorothergovernmentagencies.乙方就下列事項，可不對甲方及其參與試驗之人員負賠償責任：(1)不遵循試驗計劃書中的相關(guān)規(guī)定，(2)不遵守行政院衛(wèi)生署法規(guī)的行為。但乙方明了受試者(包括其法定繼承人及其它法定請求權(quán)人)對乙方(及乙方復委托之受托研究機構(gòu))有直接請求權(quán)。Ifthesubjectsareinsufficientordysfunctionalduetothemanufacturingofthedrugsorequipment,orsideeffectsrelatedtothisclinicaltrial,orstepsrequiredunderthisclinicaltrial,including(1)PartyA'suseoftrialdrugsorequipmentinaccordancewiththeClinicalTrialProtocol,(2)medicalexpenseswhicharenotincludedinthesubjects'drugormedicalinsurancefees,and(3)damagesoradverseeffectwhicharenotcausedbyPartyA'snegligenceorimproperbehavior,PartyBshallcompensatePartyAofreasonableandnecessarylossofmedicalexpenses.乙方就下列事項，應對甲方、甲方參與試驗之人員及/或受試者負賠償責任：(1)甲方及其參與試驗人員按照本試驗計劃書執(zhí)行，造成受試者遭受傷害。(2)不包含在受試者的醫(yī)療保險費而致使甲方、甲方之參與試驗人員及/或受試者所遭受到之損失。(3)非由甲方疏忽或失當所引起而造成之受試者傷害。Forcasessub-delegatedbyPartyB,PartyBshallensurethatthedelegatedtrialinstitutionbearthefollowingresponsibilitiesandshallbearjointliabilitywiththedelegatedtrialinstitution:(1)alllossessufferedbythesubjectsandPartyAduetotheinsufficiencyofthetrialdrugsorequipmentshallbecompensatedbythemanufacturersofthetrialdrugsorequipment;(2)alllossessufferedbythesubjectsandPartyAcausedbycontractresearchorganizationsshallbecompensatedbythecontractresearchorganizations.BothPartiesshallmaketheirbestefforttonegotiateandresolveanyconflictorcompensationissues.乙方復委托案件予受托研究機構(gòu)，乙方應使其受托研究機構(gòu)承擔以下責任，并與乙方連帶負責：(1)負責賠償研究用產(chǎn)品缺失所造成受試者及甲方之一切損害；(2)負責賠償乙方之復委托之受托研究機構(gòu)所造成受試者及甲方之一切損害。甲乙雙方應盡最大努力彼此協(xié)商解決任何的沖突或索賠問題。Insurance.保險PartyBshalltakeoutgeneralcommercialliabilityinsuranceorbeself-insuredfortheClinicalTrialProtocol.Thegeneralcommercialliabilityinsuranceorself-insuranceshouldcoverthelevelofcompensationthatPartyBshallbearunderitscontractualresponsibilities.Inaccordancewithneeds,PartyBshallprovidewrittenproofofsuchinsurancetoPartyApriortothecommencementoftheclinicaltrial.乙方或其受托研究機構(gòu)應為其臨床試驗計劃投保一般商業(yè)責任險、自身責任保險或臨床試驗保險。上述保險應可足以提供乙方在本合約責任中所需負擔的賠償。乙方應于試驗開始前提供此類保險的書面證據(jù)給甲方。Incaseofcancellation,non-renewaloramendmentofsuchinsurance,PartyBshallinformPartyAinwritingatleastfifteen(15)dayspriortotheincident.IfPartyBdoesnotfindsimilarinsuranceforsubstitutionwithinaperiodoffifteen(15)days,PartyAhastherighttoterminatethisAgreementeffectivelywithoutanyfurtherwaitingtimeandwithoutanynotificationupontheexpiryofthefifteen(15)dayperiod.乙方應于上述保險取消、不續(xù)約或更改前至少十五(15)天以書面方式告知甲方；乙方若于此十五(15)天的期間內(nèi)沒有找到其它同類的保險取代，則甲方有權(quán)在此十五(15)天的期限到期時，不經(jīng)任何的額外的等候時間且無需通知即有效的徑行終止本合約。ProtectionofPrivacy遵從隱私保護InaccordancewiththelawsandimplementationrulesoftheRepublicofChina,otherthanforthepurposeoftreatment,paymentormedicalcareprovision,PartyAmaynotuseordiscloseanyprotectedmedicalhistoryinformationwithoutauthorizationfromtheconcernedparties.PartyAshallcomplywiththeregulationsandshallobtainconsentsfromindividualsubjectswhoparticipateinthetrialandagreethatthesuchprotectedmedicalhistoryinformationshallbeusedanddisclosedbyPartyBforthepurposeofimplementingandmonitoringthetrial.PartyBagreesthatunlessauthorizedbylawsorbythesubjects,PartyBshallnotdisclosetheprotectedmedicallyhistoryinformationtoanypersonoranyentity.依據(jù)法律及其實施細則所規(guī)定，除治療目的、支付、或為了醫(yī)療照護以外，甲方不得在未經(jīng)當事人授權(quán)的情況下任意使用或透露被保護的醫(yī)療病歷數(shù)據(jù)。甲方將遵循規(guī)定，取得個別進入試驗的受試者同意，同意這些被保護的醫(yī)療病歷數(shù)據(jù)將為了達到對此試驗的進行及監(jiān)測之目的而被乙方披露及使用。乙方同意除非法律及受試者授權(quán)允許，乙方不得對任何人或任何團體揭露被保護的醫(yī)療病歷資料。Guarantee擔保PartyAdoesnotguaranteetheresultsofthisclinicaltrial,anddoesnotguaranteethemarketabilityandsuitabilityofitsownership.PartyBshallnotberesponsibleforanydirect,consequentialorotherdamagessufferedbyPartyBoranyotherpersonorentityduetotheresultsoftheclinicaltrial.甲方不擔保有關(guān)本試驗的結(jié)果，并且不保證其所有權(quán)具有可銷售性、適用性等特定的效果。甲方不需為試驗結(jié)果所引發(fā)對乙方或其它團體或個人所造成的任何直接、相應或其它的損害負責。NoWaiver非放棄追究WaiverofanybreachofcontractorfailuretoperformanyresponsibilityunderthecontractbytheotherPartyshallnotbedeemedtobeacontinuedwaiverofanysimilarrepeatedbreachesorotherbreachesorfailuretoperformresponsibilitiesunderthecontract.放棄追究另一方任何違約或不履行本合約的責任不應被視為繼續(xù)放棄對任何此類重復的違約行為或其它違約或不履行合約責任的追究。Disputes糾紛DisputesorviolationsorprovisionsarisingoutofthisAgreement,ifirreconcilablethroughnegotiations,thePartiesagreetoattempttomediatethedisputeongenuinelyfriendlybasisbeforereferringthemtoarbitrationandlitigationorseekotherdisputeresolutionprocedurestoresolvethem.ThePartiesagreethattheTaipeiDistrictCourtshallbethefirstinstaneecou