(完整版)药物临床试验英文缩写2017.1.20

1常见缩略语集1、药物临床试验英文缩写................................................22、血尿检查英文缩写.......................................................73、实验室英文缩写........................................................10更新日期：2017年1月20日21、药物临床试验英文缩略语缩略语英文全称中文全称ACActivecontrol阳性对照/活性对照ADEAdverseDrugEvent药物不良事件ADRAdverseDrugReaction药物不良反应AEAdverseEvent不良事件AIAssistantInvestigator助理研究者ALDApproximateLethalDose近似致死剂量AUCAreaunderthecure曲线下面积BMIBodyMassIndex体质指数CATDComputer-assistedtrialdesign计算机辅助试验设计CICo-investigator合作研究者COICoordinatingInvestigator协调研究者CRCClinicalResearchCoordinator临床研究协调者CRFCasereportform/caserecordform病例报告表/病例记录表CROContractResearchOrganization合同研究组织CSAClinicalStudyApplication临床研究申请CTAClinicalTrialApplication临床试验申请CTXClinicalTrialExemption临床试验免责CTPClinicalTrialProtocol临床试验方案CTRClinicalTrialReport临床试验报告DASDisabilityassessmentschedule功能残疾量表DSMBDataSafetyandmonitoringBoard数据安全及监控委员会ECGElectrocardiogram心电图EDCElectronicDataCapture电子数据采集系统EDPElectronicDataProcessing电子数据处理系统EMGElectromyography肌电图仪FASFullanalysisset全分析集FDAFoodandDrugAdministration美国食品与药品管理局FRFinalReport总结报告GASGlobalAssessmentScale总体评估量表GCPGoodClinicalPractice药物临床试验质量管理规范GLPGoodLaboratoryPractice药物非临床试验质量管理规范GMPGoodManufacturingPractice药品生产质量管理规范HIT-6HeadacheImpactTest头痛影响测定问卷IBInvestigator’sBrochure研究者手册3缩略语英文全称中文全称IBRInstitutionreviewboard机构审查委员会ICInformedConsent知情同意ICFInformedConsentForm知情同意书ICHInternationalConferenceonHarmonization国际协调会议IDMIndependentDataMonitoring独立数据监察IDMCIndependentDataMonitoringCommittee独立数据监察委员会IECIndependentEthicsCommittee独立伦理委员会INDInvestigationalNewDrug新药临床研究IRBInstitutionalReviewBoard机构审查委员会ITTIntention-to-treat意向性分析(统计学）IVDInVitroDiagnostic体外诊断IVRSInteractiveVoiceResponseSystem互动语音应答系统IWRSinteractivewebresponsesystem交互式网络响应系统MAMarketingApproval/Authorization上市许可证MCAMedicinesControlAgency英国药品监督局MHWMinistryofHealthandWelfare日本卫生福利部MIDASMigraineDisabilityAssessment偏头痛残疾程度评估问卷MSQMigraine-SpecificQualityofLifequestionnaire偏头痛特异性生活质量问卷NDANewDrugApplication新药申请NECNewDrugEntity新化学实体NIHNationalInstitutesofHealth国家卫生研究所（美国）PIPrincipalInvestigator主要研究者PLProductLicense产品许可证PMAPre-marketApproval(Application)上市前许可（申请）PPPerProtocol符合方案集PSIStatisticiansinthePharmaceuticalIndustry制药业统计学家协会QAQualityAssurance质量保证QCQualityControl质量控制RARegulatoryAuthorities监督管理部门SASiteAssessment现场评估SAESeriousAdverseEvent严重不良事件SAPStatisticalAnalysisPlan统计分析计划SARSeriousAdverseReaction严重不良反应SDSourceData/Document原始数据/文件SDSubjectDiary受试者日记SFDAStateFoodandDrugAdministration国家食品药品监督管理局4缩略语英文全称中文全称SDVSourceDataVerification原始数据核准SELSubjectEnrollmentLog受试者入选表SISub-investigator助理研究者SISponsor-Investigator申办研究者SICSubjectIdentificationCode受试者识别代码SIGNScottishIntercollegiateGuidelinesNetwork苏格兰会际指南网络标准SOPStandardOperatingProcedure标准操作规程SPLStudyPersonnelList研究人员名单SSSafetyAnalysisSet安全分析集SSLSubjectScreeningLog受试者筛选表T&RTestandReferenceProduct受试和参比试剂UAEUnexpectedAdverseEvent预料外不良事件ULNUpperLimitNormal正常值上限WHOWorldHealthOrganization世界卫生组织WHO-ICDRAWHOInternationalConferenceofDrugRegulatoryAuthoritiesWHO国际药品管理当局会议无缩略语AApproval批准Auditorinspection稽查／视察Auditreport稽查报告Auditor稽查员BBias偏性/偏倚Bioequivalence生物等效应Blankcontrol空白对照Blindcodes编制盲底Blindreview盲态审核Blindreview盲态检查Blindingmethod盲法Blinding/masking盲法/设盲CCasehistory病历Clinicalequivalence临床等效应Clinicalstudy临床研究Clinicaltrial临床试验Co-investigator合作研究者Comparison对照Compliance依从性5缩略语英文全称中文全称Compositevariable复合变量Consistencytest一致性检验Contract/agreement协议／合同Controlgroup对照组Coordinatingcommittee协调委员会DDatamanagement数据管理Documentation记录/文件Dropout脱落EEffectiveness疗效Endpoint终点EndpointCriteria终点指标Endpointcriteria/measurement终点指标Equivalence等效性EssentialDocumentation必需文件Ethicscommittee伦理委员会Excellent显效Exclusioncriteria排除标准FFailure无效/失败Finalpoint终点IInclusionCriteria入选表准Inclusioncriteria入选标准InformationGathering信息收集Initialmeeting启动会议Inspection检察/视察Institutioninspection机构检查Interimanalysis期中分析InvestigationalProduct试验药物Investigator研究者LLostoffollowup失访MMonitor监察员Monitoring监查MonitoringPlan监察计划MonitoringReport监察报告Multi-centerTrial多中心试验NNon-clinicalStudy非临床研究Non-inferiority非劣效性6缩略语英文全称中文全称OObedience依从性Open-label非盲Originalmedicalrecord原始医疗记录Outcome结果OutcomeAssessment结果评价Outcomeassessment结果指标评价Outcomemeasurement结果指标PPatientfile病人档案Patienthistory病历Placebo安慰剂Placebocontrol安慰剂对照Preclinicalstudy临床前研究Primaryendpoint主要终点Primaryvariable主要变量Protocol试验方案ProtocolAmendments修正案QQuerylistqueryform应用疑问表RRandomization随机ReferenceProduct参比制剂SSafetyevaluation安全性评价Safetyset安全性评价的数据集Samplesize样本量样本大小Scaleoforderedcategoricalratings有序分类指标Secondaryvariable次要变量Sequence试验次序SimpleRandomization简单随机Singleblinding单盲Siteaudit试验机构稽查Standardoperatingprocedure标准操作规程Sponsor申办者Sponsor-investigator申办研究者StudyAudit研究稽查Studyaudit研究稽查StudySite研究中心Subgroup亚组Sub-investigator助理研究者7缩略语英文全称中文全称Subject受试者Subject受试者Subjectdiary受试者日记SubjectEnrollment受试者入选Subjectenrollmentlog受试者入选表SubjectIdentificationCodeList受试者识别代码表SubjectRecruitment受试者招募Subjectscreeninglog受试者筛选表Systemaudit系统稽查SystemAudit系统稽查TTestProduct受试制剂Treatmentgroup试验组Trialerror试验误差TrialInitialMeeting试验启动会议TrialMasterFile试验总档案Trialobjective试验目的Trialsite试验场所Tripleblinding三盲