3_Clinical_Data_Management_and_Remote_Data_Acquisi

甲骨文公司生命科学临床研究系统介绍谭丽珊甲骨文生命保健科学业务部–技术顾问Oracle生命科学和临床研究解决方案©2009OracleCorporation–ProprietaryandConfidentialInsertPictureHereProgramAgenda•ClinicalDevelopmentandSafetyPortfolio•OracleDataManagementSolution•OracleRemoteDataCapture+Demo•电子数据采集系统•OracleClinical•临床数据管理系统•OracleThesaurusManagementsystem•医学词典管理系统©2009OracleCorporation–ProprietaryandConfidential针对临床开发的甲骨文生命科学管理软件不良事件报告不良事件报告//药物警戒药物警戒（（OracleAERSOracleAERS不良事件报告系不良事件报告系统）统）术语分类术语分类//字典管理字典管理（（OracleTMSOracleTMS词典管理系统）词典管理系统）生命科学数据中心生命科学数据中心（（OracleLSDHOracleLSDH生命科学数据中心）生命科学数据中心）临床数据管理系统临床数据管理系统（（OracleClinicalOracleClinical））临床试验管理临床试验管理（（SiebelClinicalSiebelClinical））电子数据采集电子数据采集（（OracleRDCOracleRDC远程数据获取）远程数据获取）©2009OracleCorporation–ProprietaryandConfidentialOracleHealthSciencesPlatformTheOnlyIntegrated,Open,RegulatoryCompliantPlatformforClinicalDevelopment&SafetyElectronicDataCaptureClinicalTrialManagementPharmacovigilance&SafetyClinicalDataManagementRegulatorySubmissions&ReportingSitesandExternalCollaboratorsPre-ClinicalDiscoveryFindingsAnalyticsandReporting©2009OracleCorporation–ProprietaryandConfidentialOracleHealthSciencesPlatformTheOnlyIntegrated,Open,RegulatoryCompliantPlatformforClinicalDevelopment&SafetyOHSPPre-ClinicalDiscoveryFindingsRegulatorySubmissions&ReportingSitesandExternalCollaboratorsStreamlinedDataCaptureandManagementImprovedOperationalPerformanceandDecisionMakingLowerCostofOwnershipSimplifiedClinicalDataIntegrationReducedRiskOptimizedRegulatoryReportingandSubmission©2009OracleCorporation–ProprietaryandConfidentialFullyIntegratedClinicalDataManagementandElectronicDataCapture全面整合临床数据管理和电子数据采集系统Investigator项目负责人：主任医生DataManager数据分析员DataCollection数据采集数据采集DataDiscrepancies数据差异Approve批准Review/Verify审查或验证Review/VerifyReviewOracleOracleClinicalClinicalMonitor监察员OracleRemoteDataCapture电子数据采集电子数据采集Clinician医生Monitor监察员9StudyDesignandManagement(研究设计和管理)9StudyDataDefinition(研究数据定义)9StudyConductandValidation(进行研究和验证)9DataAccessandReporting(数据存取和报告)©2009OracleCorporation–ProprietaryandConfidential针对临床开发的Oracle生命科学管理软件不良事件报告不良事件报告//药物警戒药物警戒（（OracleAERSOracleAERS不良事件报告系不良事件报告系统）统）术语分类术语分类//字典管理字典管理（（OracleTMSOracleTMS词典管理系统）词典管理系统）生命科学数据中心生命科学数据中心（（OracleLSDHOracleLSDH生命科学数据中心）生命科学数据中心）临床数据管理系统临床数据管理系统（（OracleClinicalOracleClinical））临床试验管理临床试验管理（（SiebelClinicalSiebelClinical））电子数据采集电子数据采集（（OracleRDCOracleRDC远程数据获取）远程数据获取）术语分类术语分类//字典管理字典管理（（OracleTMSOracleTMS词典管理系统）词典管理系统）临床数据管理系统临床数据管理系统（（OracleClinicalOracleClinical））电子数据采集电子数据采集（（OracleRDCOracleRDC远程数据获取）远程数据获取）©2009OracleCorporation–ProprietaryandConfidentialWhyinvestinEDC?Survey-HealthIndustryInsights•KeyBenefitsofEDCinclude(电子数据采集系统的主要优点):•formreuse重用CRF模板•queryreduction减少提交疑问的数目•databaselocking减少数据库关闭时间•projectmanagement提高项目管理效率•sitemonitoring原始数据录入监察•DataAvailability快速获得原始数据•DataQuality提高原始数据质量•Reductionincost减少项目整体花费©2009OracleCorporation–ProprietaryandConfidentialNewsFactonOracleRDC•WebbasedwithZeroInstallation–Helpstomeettheneedsoftrialsponsorsaswellasinvestigativesitepersonnelbyprovidingasimplifieduserinterfaceandeliminatingsitesoftwareinstallation.•客户端不需要安装任何程序•Thishelpstoincreasestaffefficiencybyallowinginvestigatorstoquicklylocatepatientvisitsandcasereportforms(CRFs).OracleRDCisintegratedwithOracleClinical.•快速确定病人回访和CRF表，和OC整合©2009OracleCorporation–ProprietaryandConfidentialAdvantagesofOracleRDCforSitePersonnel•Requireto:•Quicklylocateclinicalstudypatients•Examinevisits•CompleteCRFOracleRDCprovides:•Sortableandsearchablelistofpatients•Quicklyidentifystatusthroughuseoficons•LookandFeelofpapereCRF,makingiteasytocompletebynoviceuser•Efficientlylocatediscrepanciesinasinglepageview•Flagsdiscrepancyimmediatelyduringdataentry©2009OracleCorporation–ProprietaryandConfidentialAdvantagesofOracleRDCforCRAOracleRDCallowsCRAto:•Reviewdatainadvancetoprepareformonitoringvisit•Easyidentificationofissuesthroughicons(incompleteCRF)•EasilycrossreferencemultipleeCRFpages©2009OracleCorporation–ProprietaryandConfidentialAdvantagesofOracleRDCforInvestigatorsOracleRDCallowsInvestigatorsto:•Efficientlyreview•SponsorNewsandUpdates•PatientData•ReviewStudySummaryInformation©2009OracleCorporation–ProprietaryandConfidentialAdvantagesofOracleRDCforSponsorOracleRDCallowsSponsorsto:•Staycurrentonalltrialsitesthroughinternetbasedconnectivity•Immediatevisibilityandrealtimedecisions•GopaperlessandsavecostandacceleratedatacaptureFastertimetodatasubmission©2009OracleCorporation–ProprietaryandConfidentialOracleRDCSummary•ProvidesSpeedwithoutcompromiseSuccessforClinicaltrialEnsureParticipantSafety•ProvidesunsurpassedfunctionalityBetterqualitydataReducedtimetodatabaselock•CostEffectiveinternetbasedapproachSmarter,Secureandfasterwayto:•Collect•Clean•Review•Verify•approve©2009OracleCorporation–ProprietaryandConfidential针对临床开发的Oracle生命科学管理软件不良事件报告不良事件报告//药物警戒药物警戒（（OracleAERSOracleAERS不良事件报告系不良事件报告系统）统）术语分类术语分类//字典管理字典管理（（OracleTMSOracleTMS词典管理系统）词典管理系统）生命科学数据中心生命科学数据中心（（OracleLSDHOracleLSDH生命科学数据中心）生命科学数据中心）临床数据管理系统临床数据管理系统（（OracleClinicalOracleClinical））临床试验管理临床试验管理（（SiebelClinicalSiebelClinical））电子数据采集电子数据采集（（Oracle