临床英语术语缩写表

临床研究常用术语缩写表编号术语缩写英文全称/中文全称ADRAdversedrugreaction/不良反应[AEAdverseEvent/不良事件ASVAccompaniedSiteVisit/陪同访视BD业务拓展BusinessDevelopmentBS生物统计BiostatisticsCCFCentralClinicalFile申办方临床研究文件夹CDControlledDocuments/控制文件CDAConfidentialityDisclosureAgreement/保密协议CDCCenterforDiseaseControl/疾病控制中心CSDsClinicalStudyDocuments临床研究文件CECCentralEthicsCommittee/中心伦理委员会?Co-ICoordinatingInvestigator负责协调不同中心参加多中心临床试验研究者的研究者COFChangeOrderForm/工作氾围变更申请表CIFCentralInvestigator'sFile申办者研究者文件夹（中心研究者文件夹）CMClinicalMonitoring/Operations/临床监杳/运营CMAClinicalMonitoringAssociate/临床研究监查助理CRCompleteResponse痊愈CRAClinicalResearchAssociate(equivalenttoClinicalStudyMonitor)临床监查员CRCClinicalResearchCoordinator/临床研究协调员CRFCaseReportFormorCaseRecordForm/病例扌报告表CRO/ContractResearchOrganization/合同研究组织CSDsClinicalStudyDocuments/临床研究文件CSRClinicalStudyReport/临床研究报告CTAClinicalTrialAssistant(equivalenttoClinicalResearchAssistant)临床研究助理CTAClinicalTrialAgreement/临床试验协议CTAClinicalTrialApplication/临床试验申请CTSClinicalTrialSupplies/临床试验用品>CTXClinicalTrialExemption/临床试验免责

编号术语缩写英文全称/中文全称CVCurriculumVitae/履历DCFDataClarificationForm/数据澄清表DCRDataClarificationReport(seeDCF)/数据澄清报告DCRFDataClarificationandResolutionForm(seeDCF)/数据澄清和解决表DMDataManagement/数据管理DMPDataManagementPlan/数据管理计划书DQFDataQueryForm/数据疑问表DSDataSource/数据源ECEthicsCommittee/伦理委员会}eCRFElectronicCaseReportForm/电子病历扌艮告表EDCElectronicDataCapture/电子数据米集EOSEndofStudy/研究结束?EUEuropeanUnion/欧盟FASFullAnalysisSet/全分析集FDAFoodandDrugAdministration/美国食品药品管理局FMApprovedStandardForm/批准的标准表格GCPGoodClinicalPractice/临床试验质量管理规范GLPGoodLaboratoryPractice/实验室质量管理规范GMPGoodManufacturingPractice/药品生产质量管理规范【GRPGoodResearchPractice/科学研发质量管理规范GSPGoodStatisticalPractice/统计质量管理规范HCOHeadofClinicalOperations临床运营总监IBInvestigator'sBrochure/研究者手册ICInformedConsent/知情同意ICFInformedConsentForm(alsoseeIC)/矢知情同意书ICHInternationalConferenceonHarmonization/国际协调会议ICH-GCPInternationalConferenceonHarmonisationTripartiteGuidelineonGoodClinicalPractice国际协调会议药品临床试验质量管理规范指南IDBInvestigationalDrugBrochure/试验药物手册IEC《IndependentEthicCommittee/独立伦理委员会INDInvestigationalNewDrug(USFDA)/研究用新药

编号术语缩写英文全称/中文全称IPInvestigationalProduct/研究用产品IRAEsImmediatelyReportableAdverseEvents/立即上报的不良事件!IRBInstitutionalReviewBoard./机构审查委员会ITTIntentiontotreat/意向性治疗ISAInvestigatorStudyAgreement/研究者合同ISFInvestigationalSiteFile研究者文件夹LMLineManager/直线经理LOILetterofIntent/意向书MOH¥MinistryofHealth/卫生部MSAMasterServicesAgreement/主服务协议MTDMaximumToleratedDose/取大耐受剂量MWMedicalWriting/医学写作1NANotAvailable/不可用NCENewChemicalEntity/新化学实体NCSNotClinicallySignificant/无临床意义NDNotDone/未做NDANewDrugApplication./新药上市申请ODOtherDocuments/其他文件OP{OperatingProcedure/操作规程OOSOutOfScope/超工作范围OSOverallSurvival/总体生存期OTLOperationalTeamLead/运营团队负责人?PDProtocolDeviation/方案偏离PIPrincipleInvestigator/主要研究者PINPersonalIdentificationNumber/个人确认密码PKPharmacokinetics/药物代谢动力学PMProjectManager/项目经理PMFProjectManagermentFile/项目官理文件夹PMIPeriodicMaintenanceInspection/定期维护检查PMSPost-MarketingSurveillance/上市后药物检测PPProjectPlan/项目计划PPPerProtocol/付合方案集PRPatientRecruitment/患者招募

编号术语缩写英文全称/中文全称QAQualityAssurance/质量管理QCQualityControl/质量控制RARegulatoryAuthorities/监督管理部门RMRemoteMonitoring/远程监查On-SiteMonitoring/现场监查=On-TargetMonitoring/目标化监杳SAESeriousAdverseEvent/严重不良事件SCStudyCoordinator/研究协调员SCVSiteClose-outVisit/中心关闭访视SSVSiteSelectionVisit/中心筛选访视@SMVSiteMonitoringVisit/中心监杳访视SVRSiteVisitReport/中心访视报告SDSourceData/源数据SDVSourceDataVerification/原始数据核查SFDAStateFoodandDrugAdministration/国家食品药品监督管理局SICSubjectIdentificationCode/受试者识别代码SIFSiteInformationForm/中心信息表SIVSiteInitiationVisit/中心启动访视SOPStandardOperatingProcedure/标准操作规程SOWScopeofWork/工作范围Sub-ISubinvestigator次要研究者SUSARSuspectedUnexpectedSeriousAdverseReaction可疑的非预期的严重不良反应TPTemplate/模版$TMFTrialMasterFile/试验主文档UADRUnexpectedAdverseDrugReaction/非预期药物不良反应UADEUnanticipatedadversedrugeffect/非预期的不良反应UAEUnexpectedadverseevent/非预期的不良事件WIWorkInstruction/工作指南SOP类型缩写表OP操作规程OperatingProceduresWI工作指南WorkInstructionsTP模板TemplateFM批准的标准表格ApprovedStandardFormsODOD其他文件OtherDocuments业务部门缩写表/FunctionalAreaAbbreviationTable:BS生物统计BiostatisticsBD业务拓展BusinessDevelopmentCM临床监查/运营ClinicalMonitoring/OperationDataManagementInformationTechnology医学科学服务DataManagementInformationTechnology医学科学服务MedicalScienceService项目管理ProjectManagement质量保证QualityAssurance记录管理RecordsManagementAffairsIT信息技术MSPMQARMRA注册事务RegulatoryManagementSMSOP管理sopManagementST研究中心官理服务SiteManagementServiceTR培训Trai