德育基地活动记录表_(2)

YourTrustedClinicalServicePartnerinChina普蕊斯（上海）医药科技开发有限公司Dec02,2014CRCLandscapeInChina-DavidYang，serveforsitesandsponsorsSMOisaprofessionalcompanywhichprovidesclinicaltrialservicetoCROs,PharmaceuticalCompanies,BiologicalCompanies,Medical-deviceFirmsandSites.NamedasSMObecauseofitsbasedontheservicetosites.ThedifferencebetweenCROandSMOClinicalTrailSponsorCRAIRBPICROSMOCRO:ContractResearchOrganizationSMO:SiteManagementOrganizationCROcannotcontactsubjectdirectly/SMOcancontactsubjectdirectly(SMO)?TosupportadministrativeactivitiesforInstitutions,IRBsStaffarecalledSiteManagementAssociate(SMA)TosupportInvestigatorsStaffarecalledClinicalResearchCoordinator(CRC)SimilarStudyNurse(SN)orResearchCoordinator(RC)’srolesandresponsibilitiesClinicalResearchCoordinator(CRC)SiteManagementAssociate(SMA)-Totalsupportofofficeworksrelatedtoclinicaltrials-Negotiationwithsponsor,Coordinationinsidethesite-Totalmanagementfromclericalaspect-Supportclinicaltrialsoperations,mainlyinvestigators-TotalsupportfrompracticalaspectReduceburdensofoperationsatsitestaffImprovethequalityofclinicaltrials(SMO)?Institution＆IRBInvestigatorPharmaceuticalCompanyPatientMonitoringCROInformedConsentPatient’scareCRCSMOContractSMA(SMA)HandlinginquiriesaboutconductingnewstudyfromsponsorsandprovidingassistanceforsiteselectionAssistingpaymentmanagementonbehalfofsitesOrganizinginternalbillingprocedureofuninsuredmedicalcostsPreparingclinicaltrialoperationreportPreparingandfilingofessentialdocumentsCommunicatingwithCRAAssistingthesitestohandleauditbysponsorAssistingthesitestohandleGCPon-siteauditbyJapanauthoritiesSchedulingIRBmeetingPreparingdocumentsforIRBreviewanddistributiontoIRBcommitteemembersHostingIRBmeetingTakingMinutesinIRBmeetingFilingofessentialdocumentsrelatedtoIRBOrganizeprotocolstudymeetingandstart-upmeetingDevelopingandconcludingClinicalTrialAgreement(CTA)(CRC)Confirmingpatients’eligibilityforstudyunderthesupervisionofPrincipalInvestigator(PI)AssistingPItogetpatients’informedconsentArranginghospitalvisits/examinationschedulesforpatientsFilingandpreparingessentialdocumentsandmaterialsrelatedtothestudies,AssistingPItofillintheCRFCommunicatingwithCRAAssistingPItodevelopSAEreport:FamiliarwithhospitaloperationsChallenges:Lackof•Knowledge&trainingonGCPandconductingclinicaltrials•Operationproceduresandprocesses•Technologysupport•GuidancefrominvestigatorsSiteStudyNursesAdvantages:CostEffectiveChallenges:•Transitionalhumanresourcesoutsourcing•Lackofcomprehensivetrainingornotrainingatall•Increasedextraresourcesandbudgetforthesponsors/CROstotrain/manageCRCs•Lackofasenseofbelonging•HighturnoverrateStaffingCRCsProactiveownershipapproachSMOClinPlusIPMIntegratedProjectManagement#1SMO•ProjectBasedServices•Sitequickstart-up•IPM:Lackof•Knowledge&trainingonGCPandconductingclinicaltrials•Operationproceduresandprocesses•Technologysupport•GuidancefrominvestigatorsSiteStudyNurses-CCBR,STARTetc-SunYat-senUniversityCancerCenter-ShanghaiFudanUniversityShanghaiCancerCenter-PreferredSMOvendor:•Transitionalhumanresourcesoutsourcing•Lackofcomprehensivetrainingornotrainingatall•Increasedextraresourcesandbudgetforthesponsors/CROstotrain/manageCRCs•Lackofasenseofbelonging•HighturnoverrateStaffingCRCsStaffingCRCs－Atpresent,mostSMOsareaffectedbysponsorsandturningtothepatternofprojectmanagement－Businessmodelfocuson“CRC”－Thepioneerofprojectmanagement－Transplantedsmotechnologysystermtosites－NoanyEconomiccontractswithsitesBuildingloosenedcoalitionswithsitesdependonprofessionalservice－Themodelofresourceintegration－Themodelofcultivatingindustry－ProactiveownershipapproachSMOClinPlusIPMIntegratedProjectManagement#1SMO•ProjectBasedServices•Sitequickstart-up•IPM