临床试验英语词汇

临床试验英语词汇临床试验英语词汇临床试验英语词汇资料仅供参考文件编号：2022年4月临床试验英语词汇版本号：A修改号：1页次：1.0审核：批准:发布日期：专业术语、缩略语中英对照表缩略语英文全称中文全称ABEAverageBioequivalence平均生物等效性ACActivecontrol阳性对照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ALBAlbumin白蛋白ALDApproximateLethalDose近似致死剂量ALPAlkalinephosphatase碱性磷酸酶ALTAlanineaminotransferase丙氨酸转氨酶ANDAAbbreviatedNewDrugApplication简化新药申请ANOVAAnalysisofvariance方差分析ASTAspartateaminotransferase天冬氨酸转氨酶ATRAttenuatedtotalreflection衰减全反射法BABioavailability生物利用度BEBioequivalence生物等效性BMIBodyMassIndex体质指数BUNBloodureanitrogen血尿素氮CATDComputer-assistedtrialdesign计算机辅助试验设计CDERCenterofDrugEvaluationandResearch药品评价和研究中心CFRCodeofFederalRegulation美国联邦法规CICo-Investigator合作研究者CIConfidenceInterval可信区间COICoordinatingInvestigator协调研究者CRCClinicalResearchCoordinator临床研究协调者CRFCaseReport/RecordForm病历报告表/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CTPClinicalTrialProtocol临床试验方案CTRClinicalTrialReport临床试验报告CTXClinicalTrialExemption临床试验免责CHMPCommitteeforMedicinal人用药委会ProductsforHumanUseDSCDifferentialscanning差示扫描热量计DSMBDataSafetyandmonitoringBoard数据安全及监控委员会EDCElectronicDataCapture电子数据采集系统EDPElectronicDataProcessing电子数据处理系统EWPEuropeWorkingParty欧洲工作组FDAFoodandDrugAdministration美国食品与药品管理局FRFinalReport总结报告GCPGoodClinicalPractice药物临床试验质量管理规范GCPGoodLaboratoryPractice药物非临床试验质量管理规范GLUGlucose葡萄糖GMPGoodManufacturingPractice药品生产质量管理规范HEVHealtheconomicevaluation健康经济学评价IBInvestigator’sBrochure研究者手册IBEIndividualBioequivalence个体生物等效性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IVDInVitroDiagnostic体外诊断IVRSInteractiveVoiceResponseSystem互动语音应答系统LD50Mediallethaldose半数致死剂量LLOQLowerLimitofquantitation定量下限LOCFLastobservationcarryforward最接近一次观察的结转LOQLimitofQuantitation检测限MAMarketingApproval/Authorization上市许可证MCAMedicinesControlAgency英国药品监督局MHWMinistryofHealthandWelfare日本卫生福利部MRTMeanresidencetime平均滞留时间MTDMaximumToleratedDose最大耐受剂量NDNotdetectable无法定量NDANewDrugApplication新药申请NECNewDrugEntity新化学实体NIHNationalInstitutesofHealth国家卫生研究所（美国）NMRNuclearMagneticResonance核磁共振PDPharmacodynamics药效动力学PIPrincipalInvestigator主要研究者PKPharmacokinetics药物动力学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QAUQualityAssuranceUnit质量保证部门QCQualityControl质量控制QWPQualityWorkingParty质量工作组RARegulatoryAuthorities监督管理部门REVRevision修订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SDVSourceDataVerification原始数据核准SELSubjectEnrollmentLog受试者入选表SFDAStateFoodandDrugAdministration国家食品药品监督管理局SISponsor-Investigator申办研究者SISub-investigator助理研究者SICSubjectIdentificationCode受试者识别代码SOPStandardOperatingProcedure标准操作规程SPLStudyPersonnelList研究人员名单SSLSubjectScreeningLog受试者筛选表T&RTestandReferenceProduct受试和参比试剂T－BILTotalBilirubin总胆红素T－CHOTotalCholesterol总胆固醇TGThromboglobulin血小板球蛋白TmaxTimeofmaximumconcentration达峰时间TPTotalproteinum总蛋白UAEUnexpectedAdverseEvent预料外不良事件WHOWorldHealthOrganization世界卫生组织WHO-WHOInternationalConferenceWHO国际药品管理当局会议ICDRAofDrugRegulatoryAuthoritiesAberrantresult异常结果Absorptionphase吸收相Absorption吸收Accuracy准确度Accurate精密度Administer给药Amendment修正案Approval批准Assess估计AuditReport稽查报告Audit稽查Auditor稽查员Analyticalrun/batch：分析批Benefit获益Bias偏性，偏倚Bioequivalence生物等效Biosimilar/Follow-onbiologics生物仿制药BlankControl空白对照Blindcodes编制盲底Blindreview盲态检查/盲态审核Blindingmethod盲法Blinding/masking盲法/设盲Blocksize每段的长度Block层/分段BCS生物药剂学分类系统Carryovereffect延滞效应Casehistory病历Clinicalequivalence临床等效性Clinicalstudy临床研究ClinicalTrialReport临床试验报告Comparison对照Compensation补偿，赔偿金Compliance依从性Concomitant伴随的Conduct行为Confidencelevel置信水平Consistencytest一致性检验Contract/agreement协议／合同Controlgroup对照组CoordinatingCommittee协调委员会Crossoverdesign交叉设计Cross-overStudy交叉研究Cure痊愈Datamanagement数据管理Descriptivestatisticalanalysis描述性统计分析Dichotomies二分类Dispense分布Diviation偏差Documentation记录／文件Dosageforms剂型Dosedumping剂量倾卸（药物迅速释放入血而达到危险浓度）Dose-reactionrelation剂量－反应关系Doubleblinding双盲Doubledummy双模Dropout脱落Effectiveness疗效Eliminationphase消除相Emergencyenvelope应急信件Enantiomers对映体Endpoint终点Endpointcriteria/measurement终点指标Enterohepaticrecycling肠肝循环EssentialDocumentation必需文件Ethical伦理的Ethicscommittee伦理委员会Evaluate评估ExclusionCriteria排除标准Excretion排泄Expedite促进Extrapolated外推的Essentiallysimilarproduct：基本相似药物Factorialdesign析因设计Failure无效，失败Finacing财务，资金Finalpoint终点Firstpassmetabolism首过代谢Fixed-doseprocedure固定剂量法Fullanalysisset全分析集GC－FTIR气相色谱－傅利叶红外联用GC－MS气相色谱－质谱联用Genericdrug通用名药Genemutation基因突变Genotoxicitytests生殖毒性试验Globalassessmentvariable全局评价变量Groupsequentialdesign成组序贯设计Hypothesistest假设检验Highlypermeable：高渗透性Highlysoluble：高溶解度Highlyvariabledrug：高变异性药物Highly：VariableDrug高变异性药物HVDP：高变异药物制剂Identification鉴别，身份证Improvement好转Invitro体外Invivo体内InclusionCriteria入选表准InformationGathering信息收集InitialMeeting启动会议Inspection检察/视察InstitutionInspection机构检察Instruction指令，说明Integrity完整，正直Intercurrent中间发生的，间发的Inter-individualvariability个体间变异性Interimanalysis期中分析InvestigationalProduct试验药物Investigator研究者Involve引起，包括IR红外吸收光谱InnovatorProduct：原创药Ka吸收速率常LC－MS液相色谱－质谱联用logarithmictransformation对数转换Logiccheck逻辑检查Lostoffollowup失访Mask面具，掩饰Matchedpair匹配配对Metabolism代谢Missingvalue缺失值Mixedeffectmodel混合效应模式Modifiedreleaseproducts改良释放剂型Monitor监查员MonitoringPlan监察计划MonitoringReport监察报告MS－MS质谱－质谱联用Multi-centerTrial多中心试验Negative阴性，否定的Non-clinicalStudy非临床研究Non-inferiority非劣效性Non-LinearPharmacokinetics非线性药代动力学Non-parametricstatistics非参数统计方法NTID：窄治疗指数制剂Obedience依从性Open-blinding非盲Open-label非盲OriginalMedicalRecord原始医疗记录OutcomeAssessment结果评价Outcomemeasurement结果指标Outlier离群值OIP经口服吸收药物Parallelgroupdesign平行组设计Parameterestimation参数估计Parametricstatistics参数统计方法Patientfile病人档案PatientHistory病历Perprotocol，PP符合方案集Permeability渗透性Pharmacodynamiccharacteristics药效学特征Pharmacokineticcharacteristics药代学特征PlaceboControl安慰剂对照Placebo安慰剂Polytomies多分类Post-dosingpostures给药后坐姿Potential潜在的Power检验效能Precision精密度PreclinicalStudy临床前研究Precursor母体前体Premature过早的，早发Primaryendpoint主要终点Primaryvariable主要变量Prodrug药物前体Protocolamendment方案补正ProtocolAmendments修正案Protocol试验方案QualityControlSample：质控样品Rapidlydissolving：快速溶出Racemates外消旋物Randomization随机/随机化Rangecheck范围检Ratingscale量表Recruit招募，新会员Replication可重复Retrieval取回，补修Revise修正Risk风险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Samplingschedules采血计划Scaleoforderedcategoricalratings有序分类指标Secondaryvariable次要变量Sequence试验次序Seriousness严重性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Solubility溶解度Specificity特异性Specify叙述，说明Sponsor-investigator申办研究者Standardcurve标准曲线Statisticalmodel统计模型Statisticaltables统计分析表Steadystate稳态Storage储存Stratified分层StudyAudit研究稽查StudySite研究中心Subgroup亚组Sub-investigator助理研究者SubjectEnrollmentLog受试者入选表SubjectEnrollment受试者入选SubjectIdentificationCodeList受试者识别代码表SubjectRecruitment受试者招募SubjectScreeningLog受试者筛选表Subject受试者Submit交付，委托Superiority检验Supplemental增补的Supra