临床试验以及实验室中常见的中英文名词及缩写

精品中国创新药咨询与服务先锋 CRO临床试验以及实验室中常见的英文缩写感谢下载载精品感谢下载载精品药物临床试验英文缩写缩略语英文全称ADEAdverseDrugEventADRAdverseDrugReactionAEAdverseEventAIAssistantInvestigatorBMIBodyMassIndexCICo-investigatorCOICoordinatingInvestigatorCRCClinicalResearchCoordinatorCRFCaseReportFormCROContractResearchOrganizationCSAClinicalStudyApplicationCTAClinicalTrialApplicationCTXClinicalTrialExemptionCTPClinicalTrialProtocolCTRClinicalTrialReportDSMBDataSafetyandmonitoringBoardEDCElectronicDataCaptureEDPElectronicDataProcessingFDAFoodandDrugAdministrationFRFinalReportGCPGoodClinicalPracticeGCPGoodLaboratoryPracticeGMPGoodManufacturingPracticeIBInvestigator’sBrochureICInformedConsentICFInformedConsentFormICHInternationalConferenceonIDMIndependentDataMonitoringIDMCIndependentDataMonitoringIECIndependentEthicsCommitteeINDInvestigationalNewDrugIRBInstitutionalReviewBoardIVDInVitroDiagnosticIVRSInteractiveVoiceResponseSystemMAMarketingApproval/AuthorizationMCAMedicinesControlAgencyMHWMinistryofHealthandWelfareNDANewDrugApplicationNECNewDrugEntityNIHNationalInstitutesofHealth

中文全称药物不良事件药物不良反应不良事件助理研究者体质指数合作研究者协调研究者临床研究协调者病历报告表合同研究组织临床研究申请临床试验申请临床试验免责临床试验方案临床试验报告数据安全及监控委员会电子数据采集系统电子数据处理系统美国食品与药品管理局总结报告药物临床试验质量管理规范药物非临床试验质量管理规范药品生产质量管理规范研究者手册知情同意知情同意书国际协调会议独立数据监察独立数据监察委员会独立伦理委员会新药临床研究机构审查委员会体外诊断互动语音应答系统上市许可证英国药品监督局日本卫生福利部新药申请新化学实体国家卫生研究所（美国）感谢下载载精品缩略语 英文全称PI PrincipalInvestigatorPL ProductLicensePMA Pre-marketApproval(Application)PSI StatisticiansinthePharmaceuticalQA Quality AssuranceQC QualityControlRA Regulatory AuthoritiesSA SiteAssessmentSAE SeriousAdverseEventSAP StatisticalAnalysisPlanSAR SeriousAdverseReactionSD SourceData/DocumentSD SubjectDiarySFDA StateFoodandDrugAdministrationSDV SourceDataVerificationSEL SubjectEnrollmentLogSI Sub-investigatorSI Sponsor-InvestigatorSIC SubjectIdentificationCodeSOP StandardOperatingProcedureSPL StudyPersonnelListSSL SubjectScreeningLogT&R TestandReferenceProductUAE UnexpectedAdverseEventWHO WorldHealthOrganizationWHO-ICDRA WHOInternationalConferenceofDrugRegulatoryAuthorities

中文全称主要研究者产品许可证上市前许可（申请）制药业统计学家协会质量保证质量控制监督管理部门现场评估严重不良事件统计分析计划严重不良反应原始数据/文件受试者日记国家食品药品监督管理局原始数据核准受试者入选表助理研究者申办研究者受试者识别代码标准操作规程研究人员名单受试者筛选表受试和参比试剂预料外不良事件世界卫生组织WHO国际药品管理当局会议感谢下载载精品药物临床试验英文缩写英文全称AccuracyActivecontrol,ACAdversedrugreaction,ADRAdverseevent,AEAdversemedicaleventsAdversereactionAlbALD（ApproximateLethalDose ）ALPAlphaspendingfunctionALTAnalysissetsApprovalAssistantinvestigatorASTATRAUCssAuditAuditorinspectionAuditreportAuditorBiasBioequivalenceBlankcontrolBlindcodesBlindreviewBlindreviewBlindingmethodBlinding/maskingBlockBlocksizeCarryovereffectCasehistoryCasereportform/caserecordformCRFCategoricalvariable

中文全称准确度阳性对照 活性对照药物不良反应不良事件不良医学事件药物不良反应白蛋白近似致死剂量碱性磷酸酶消耗函数丙氨酸氨基转换酶统计分析的数据集批准助理研究者天门冬酸氨基转换酶衰减全反射法稳态血药浓度－时间曲线下面积稽查稽查／视察稽查报告稽查员偏性偏倚生物等效应空白对照编制盲底盲态审核盲态检查盲法盲法/设盲层每段的长度延滞效应病历病例报告表病例记录表分类变量感谢下载载英文全称CavCDCLClinicalequivalenceClinicalstudyClinicalstudyreportClinicaltrialClinicaltrialapplication CTAClinicaltrialexemption CTXClinicaltrialprotocolCTPClinicaltrial/studyreportCmaxCo-investigatorComparisonComplianceCompositevariableComputer-assistedtrialdesignCATDConfidenceintervalConfidencelevelConsistencytestContractresearchorganizationCROContract/agreementControlgroupCoordinatingcommitteeCreaCRF(casereportform)CrossoverdesignCross-overStudyCssCureDatamanagementDatabaseDescriptivestatisticalanalysisDFDichotomiesDiviationDocumentation

精品中文全称平均浓度圆二色谱清除率临床等效应临床研究临床试验的总结报告临床试验临床试验申请临床试验免责临床试验方案临床试验报告峰浓度合作研究者对照依从性复合变量计算机辅助试验设计可信区间置信水平一致性检验合同研究组织协议／合同对照组协调委员会肌酐病例报告表交叉设计交叉研究稳浓度痊愈数据管理建立数据库描述性统计分析波动系统二分类偏差记录／文件感谢下载载英文全称Dose-reactionrelationDoubledummyDoubledummytechniqueDropoutDSCEffectivenessElectronicdatacaptureEDCElectronicdataprocessingEDPEmergencyenvelopeEndpointEndpointCriteriaEndpointcriteria/measurementEquivalenceEssentialDocumentationEthicscommitteeExcellentExclusioncriteriaFactorialdesignFailureFinalpointFixed-doseprocedureForcedtitrationFullanalysissetGC－FTIRGC－MSGenericdrugGlobalassessmentvariableGLUGoodclinicalpractice,GCPGoodmanufacturepractice,GMPGoodnon-clinicallaboratorypractice,GLPGroupsequentialdesignHealtheconomicevaluation,HEVHypothesistestHypothesistestingImprovementInclusionCriteria

精品中文全称剂量－反应关系双模拟双盲双模拟技术脱落差示扫描热量计疗效电子数据采集系统电子数据处理系统应急信件终点终点指标终点指标等效性必需文件伦理委员会显效排除标准析因设计无效失败终点固定剂量法强制滴定全分析集气相色谱－傅利叶红外联用气相色谱－质谱联用通用名药全局评价变量血糖药物临床试验质量管理规范药品生产质量管理规范药物非临床研究质量管理规范成组序贯设计健康经济学评价假设检验假设检验好转入选表准感谢下载载精品英文全称InclusioncriteriaIndependentethicscommittee IECInformationconsentform ICFInformationGatheringInformedconsentICInitialmeetingInspectionInstitutioninspectionInstitutionreviewboard,IBRIntention-to –treat ITTInteractivevoiceresponsesystem IVRSInterimanalysisInternational Conference ofHarmonizationInvestigationalProductInvestigatorInvestigator ’sbrochure,IBLastobservationcarryforward,LOCFLC－MSLD50LOCF,LastobservationcarryforwardLogiccheckLOQ(LimitofQuantization)LostoffollowupMarketingapproval/authorizationMatchedpairMissingvalueMixedeffectmodelMonitorMonitoringMonitoringPlanMonitoringReportMRTMSMS－MSMTD（MaximumToleratedDose ）Multi-centerTrial

中文全称入选标准独立伦理委员会知情同意书信息收集知情同意启动会议检察/视察机构检查机构审查委员会意向性分析(－统计学）互动式语音应答系统期中分析人用药品注册技术要求国际技术协调会国际协调会议试验药物研究者研究者手册最接近一次观察的结转液相色谱－质谱联用板数致死剂量最近一次观察的结转逻辑检查定量限失访上市许可证匹配配对缺失值混合效应模式监察员监查监察计划监察报告平均滞留时间质谱质谱－质谱联用最大耐受剂量多中心试验感谢下载载英文全称NewchemicalentityNCENewdrugapplication NDANMRNon-clinicalStudyNon-inferiorityNon-parametricstatisticsObedienceODROpen-labelOptionaltitrationOriginalmedicalrecordOutcomeOutcomeAssessmentOutcomeassessmentOutcomemeasurementOutlierParallelgroupdesignParameterestimationParametricstatisticsPatientfilePatienthistoryPerprotocol PPPlaceboPlacebocontrolPolytomiesPowerPrecisionPreclinicalstudyPrimaryendpointPrimaryvariablePrincipleinvestigator PIProductlicensePLProtocolProtocolAmendmentsQualityassuranceQAQualityassuranceunitQAUQualitycontrolQC

精品中文全称新化学实体新药申请核磁共振谱非临床研究非劣效性非参数统计方法依从性旋光光谱非盲随意滴定原始医疗记录结果结果评价结果指标评价结果指标离群值平行组设计参数估计参数统计方法病人档案病历符合方案集安慰剂安慰剂对照多分类检验效能精密度临床前研究主要终点主要变量主要研究者产品许可证试验方案修正案质量保证质量保证部门质量控制感谢下载载精品英文全称中文全称Querylistqueryform应用疑问表Randomization随机Rangecheck范围检查Ratingscale量表ReferenceProduct参比制剂RegulatoryauthoritiesRA监督管理部门Replication可重复RSD日内和日间相对标准差Runin准备期Safetyevaluation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SeriousadverseeventSAE严重不良事件SeriousadversereactionSAR严重不良反应Seriousness严重性Severity严重程度Severity严重程度Significantlevel检验水准SimpleRandomization简单随机Singleblinding单盲Siteaudit试验机构稽查SOP试验室的标准操作规程SourcedataSD原始数据SourcedataverificationSDV原始数据核准SourcedocumentSD原始文件Specificity特异性Sponsor申办者Sponsor-investigator申办研究者Standardcurve标准曲线StandardoperatingprocedureSOP标准操作规程Statistic统计量Statisticalanalysisplan统计分析计划Statisticalmodel统计模型Statisticaltables统计分析表感谢下载载英文全称StratifiedStudyAuditStudyauditStudySiteSubgroupSub-investigatorSubjectSubjectSubjectdiarySubjectEnrollmentSubjectenrollmentlogSubjectidentificationcodeSICSubjectIdentificationCodeListSubjectRecruitmentSubjectscreeninglogSuperioritySurvivalanalysisSXRDSystemauditSystemAuditT1/2TargetvariableT－BILT－CHOTestProductTGTLC、HPLCTmaxTPTransformationTreatmentgroupTrialerrorTrialInitialMeetingTrialMasterFileTrialobjectiveTrialsiteTripleblinding

精品中文全称分层研究稽查研究稽查研究中心亚组助理研究者受试者受试者受试者日记受试者入选受试者入选表受试者识别代码受试者识别代码表受试者招募受试者筛选表检验生存分析单晶X－射线衍射系统稽查系统稽查消除半衰期目标变量总胆红素总胆固醇受试制剂热重分析制备色谱峰时间总蛋白变量变换试验组试验误差试验启动会议试验总档案试验目的试验场所三盲感谢下载载精品英文全称中文全称Twoone-sidetest双单侧检验Un-blinding揭盲UnexpectedadverseeventUAE预料外不良事件UV－VIS紫外－可见吸收光谱Variability变异Variable变量Visualanalogyscale直观类比打分法Visualcheck人工检查Vulnerablesubject弱势受试者Wash-out洗脱Washoutperiod洗脱期感谢下载载精品实验室检查英文缩写英文全称血常规WBCwhitebloodcellcountGR%granulocyteLY%lymphocyteMID%EOS%eosimophilAL%allergylymphocyteST%RBCredbloodcellHGBhemoglobinHCThematocrit 红细胞比积MCVmeancorpusularvolumeMCHmeancorpusularhemoglobinMCHCmeancorpuscularhemoglobinconcerntrationRDWredbloodcellvolumedistributionPLT/BPCplateletcount/bloodplateletMPVmeanplateletvolumePCTplateletocritPDWplateletdistributionwidth尿便常规PHacidityNITnitriteGLUglucoseSGspecificgravityPROproteinBLDbloodBILbilirubinUROurobilinogenWBCwhitebloodcelladdish 计数addishcount/HPhighpowerobjective/LPlowpowerobjectiveOBoccultbloodtest体液常规CSFcerebrospinalPandypandy

中文全称白细胞计数中性粒细胞百分比淋巴细胞百分比中值细胞百分比嗜酸性粒细胞百分比变异淋巴细胞百分比中性杆状粒细胞百分比红细胞计数血红蛋白红细胞比积平均红细胞体积平均红细胞血红蛋白含量平均红细胞血红蛋白浓度红细胞分布宽度变异血小板计数平均血小板体积血小板比积血小板分布宽度酸碱度亚硝酸盐尿糖比重尿蛋白隐血尿胆红素尿胆原白细胞艾迪氏计数每高倍视野每低倍视野大便隐血试验脑积夜庞氏试验感谢下载载英文全称生化检验TBtotalbilirubinDBdirectbilirubinTPtotalproteinALBalbuminGLOBglobulinUREAureaCREAcreatinineUAuricacidGLUglucoseALTalanineamiotransferaseASTaspartateaminotransferaseGGTγ-glutamyltranspeptadaseCKcreatinekinaseCK-MBcreatinekinase-MBLDHlactatedehydrogenase-HBDα-hydroxybutyricdehydrogenaseAMYserumamylaseTGtriglycerideCHOLcholesterolHDL-chigh-densitylipoproteinLDL-clow-densitylipoproteincholesterolVLDLverylow-densitylipoproteinCaserumcalciumMgserummagnesiumIPinorganicphosphateALPalkalinephosphataseTB