initialprotocolapplication-lau：最初的协议中的应用-刘

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1、^44^1二gLebaneseAmericanUniversityInstitutionalReviezuBoard(IRB)InitialProtocolApplicationBiomedicalResearchPleaseusethisapplicationifyouareapplyingforanewresearchprojectinvolvinghumansubjectsthatrequireFullorExpeditedReview.InordertocheckifyourprojectmightbeExempt

2、fromIRBreview^pleasechecktheExemptCriteriadetailedintheIRBProtocolExentMApplication.TheDocumentSubmissionChecklistbelowprovidesageneralguideregardingtherequireddocuments，asapplicable，tobesubmittedwiththisapplication*Foranyassistance,pleasecontacttheIRBOffice.Depar

3、tment/School:I.RESEARCHPROJECTINFORMATIONNameofPrincipalInvestigator(PI):ResearchProject/StudyTitle:DOCUMENTSUBMISSIONCHECKLIST—INITIALPROTOCOLSUBMISSIONOneOriginalHardCopyandoneElectronicCopyofeachofthefollowingitemsarerequiredasapplicable:ICoverletterdetailinga

4、llsubmitteddocumentswithcorrespondingversiondatesCompletedandsignedInitialProtocolApplicationAdetailedprotocolorresearchprojectGrantApplication/studycontractand/orClinicalTrialAgreement(CTA)includingdetailedbudgetinformationInformedconsentfonn(s)includinganyshortf

5、ormsandtranslations;assentformforresearchinvolvingchildrenRecruitmentmaterials(coverletters,brochures,emailnotices/referrals,advertisementsincludingtranslationsResearchInstrumentse.g.diaries,surveys,questionnaires,QualityofLifehandouts,telephonescripts,etcEducatio

6、nalmaterialsincludinginformationsheets,studyguidesInvestigator'sBrochure,ProductMonograph,PackageInsert,orDeviceManualProduct・NewDrugApplicationorInvestigationalDeviceApplicationIndemnificationdocumentation,ifapplicable(fordruganddevicestudies)Studymaterialincludi

7、ngcasereportformanddatacollectiontoolsHumanSubjectProtectiontrainingcertificateforallstudypersonnel,validwithin2yearsfromdateoncertificate(ProtectingHivrumSubjectResearchParticipants)CurricularVitaeforthePrincipalInvestigatorandanyCo-investigatorinvolvedinsubjectc

8、ontactInvestigatorFinancialDisclosureFormcompletedandsignedforallPlandotherinvestigatorsDONOTWRITEINTHISSECTION.FOROFFICIALIRBUSEONLY.DateReceived:IRBTr