药品临床试验合约内容参考範本

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1、藥品臨床試驗合約內容參考範本檢核表請勾選您已檢附之項目頁碼條文編號確認備齊(V)CoverpagePreamble1.ResponsibilityofInvestigatorsandResearchStaff2.ResponsibilityofSponsor3.CommencementandDuration4.Funding5.Protocol6.StudyConduct7.Confidentiality&IntellectualProperty9.IndependentEthicsCommitteeorInstitutionalReviewBoard10.D

2、ataProtectionandFinancialDisclosure11.InformedConsentandSubjectRecruitment12.AdverseEventReporting13.InvestigationalDrug14.StudyData,BiologicalSamples,andStudyRecords15.Monitoring,Inspections,andAudits16.Publications17.Indemnification18.Termination19.UseofName20.IndependentContracto

3、r21.Anti-corruption22.ApplicableLawandJurisdiction23.MiscellaneousARTICLEREFERENCECLAUSESANNOTATIONCoverPageCLICALTRIALAGREEMENTbetweenDr.[InsertInvestigator^name][InsertInvestigator^address](hereinafterreferredtoasthe"Investigator”)and[InsertInstitution'sname][InsertInstitution'sad

4、dress](hereinafterreferredtoasthe"Institution，，)and[InsertSponsor^name],tradingas[InsertSponsor^nameabbreviation][InsertSponsor^address](hereinafterreferredtoas“[InsertSponsor^nameabbreviation]^^)Protocolnumber:[InsertProtocolnumber]PreambleInsertNameandAddress("SPONSOR”)desirestore

5、tainInsertInstitutionNameandAddress("Institution^)toconductaclinicalstudy(the"Study")inrelationtoInsertProductName(the"InvestigationalDrug(s)v)effectiveasofthedatethisClinicalStudyAgreement(the"Agreemenfr)isfullyexecuted(the"EffectiveDate')Inconsiderationofthemutualpromisessetforthh

6、erein,thepartiesagreeasfollows:1.Preambleistoidentifyanddefinethepartiesandthenatureoftheagreement.11.RESPONSIBILITYOFINVESTIGATORSANDRESEARCHSTAFF1.1PrincipalInvestigator.TheStudywillbeconductedbyInsertInvestigatorsName(PrincipalInvestigator).InstitutionagreestonotifySponsorassoona

7、spracticableifInvestigatorwillbeleavingtheInstitutionorisotherwisenolongerabletoperformtheStudy.TheappointmentofanewInvestigatormusthavethepriorapprovalofSponsor.1.2SubinvestigatorsandResearchStaff.PrincipalInvestigatorandInstitutionwillensurethatonlyindividualswhoareappropriatelytr

8、ainedandqualifiedas