Accuracy?准确度Active control，?AC?阳性对照，活性对照Adverse drug reaction，?ADR?药物不良反应Adverse event，?AE?不良事件Adverse medical events?不良医学事件Adverse reaction?药物不良反应Alb?白蛋白ALD（Approximate Lethal Dose）?近似致死剂量ALP?碱性磷酸酶Alpha spending function?消耗函数ALT?丙氨酸氨基转换酶Analysis sets?统计分析的数据集Approval?批准Assistant investigator?助理研究者AST?天门冬酸氨基转换酶ATR?衰减全反射法AUCss?稳态血药浓度－时间曲线下面积Audit?稽查Audit or inspection?稽查／视察Audit report?稽查报告Auditor?稽查员Bias?偏性，偏倚Bioequivalence?生物等效应Blank control?空白对照Blind codes?编制盲底Blind review?盲态审核Blind review?盲态检查Blinding method?盲法Blinding/ masking?盲法，设盲Block?分段Block?层Block size?每段的长度BUN?尿素氮Carryover effect?延滞效应Case history?病历Case report form?病例报告表Case report form/ case record form，?CRF?病例报告表，病例记录表Categorical variable?分类变量Cav?平均浓度CD?圆二色谱CL?清除率Clinical equivalence?临床等效应Clinical study?临床研究Clinical study report?临床试验的总结报告Clinical trial?临床试验Clinical trial application，?CTA?临床试验申请Clinical trial exemption，?CTX?临床试验免责Clinical trial protocol，?CTP?临床试验方案Clinical trial/ study report?临床试验报告Cmax?峰浓度Co-investigator?合作研究者Comparison?对照Compliance?依从性Composite variable?复合变量Computer-assisted trial design，?CATD?计算机辅助试验设计Confidence interval?可信区间Confidence level?置信水平Consistency test?一致性检验Contract research organization，?CRO?合同研究组织Contract/ agreement?协议／合同Control group?对照组Coordinating committee?协调委员会Crea?肌酐CRF（case report form）?病例报告表Crossover design?交叉设计Cross-over study?交叉研究Css?稳浓度Cure?痊愈Data management?数据管理Database?建立数据库Descriptive statistical analysis?描述性统计分析DF?波动系统Dichotomies?二分类Diviation?偏差Documentation?记录／文件Dose-reaction relation?剂量－反应关系Double blinding?双盲Double dummy?双模拟Double dummy technique?双盲双模拟技术Double-blinding?双盲Drop out?脱落DSC?差示扫描热量计Effectiveness?疗效Electronic data capture，?EDC?电子数据采集系统Electronic data processing，?EDP?电子数据处理系统Emergency envelope?应急信件End point?终点Endpoint criteria/ measurement?终点指标Equivalence?等效性Essential documentation?必须文件Ethics committee?伦理委员会Excellent?显效Exclusion criteria?排除标准Factorial design?析因设计Failure?无效，失败Final point?终点Fixed-dose procedure?固定剂量法Forced titration?强制滴定Full analysis set?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Generic drug?通用名药Global assessment variable?全局评价变量GLU?血糖Good clinical practice，?GCP?药物临床试验质量管理规范Good manufacture practice，?GMP?药品生产质量管理规范Good non-clinical laboratory practice，?GLP?药物非临床研究质量管理规范Group sequential design?成组序贯设计Health economic evaluation，?HEV?健康经济学评价Hypothesis test?假设检验Hypothesis testing?假设检验International Conference of Harmonization，?ICH?人用药品注册技术要求国际技术协调会，国际协调会议Improvement?好转Inclusion criteria?入选标准Independent ethics committee，?IEC?独立伦理委员会Information consent form，?ICF?知情同意书Information gathering?信息收集Informed consent，?IC?知情同意Initial meeting?启动会议Inspection?视察／检查Institution inspection?机构检查Institution review board，?IBR?机构审查委员会Intention to treat?意向治疗（——?临床领域）Intention-to?–treat，?ITT?意向性分析（－?统计学）Interactive voice response system，?IVRS?互动式语音应答系统Interim analysis?期中分析Investigator?研究者Investigator's brochure，?IB?研究者手册IR?红外吸收光谱Ka?吸收速率常Last observation carry forward，?LOCF?最接近一次观察的结转LC－MS?液相色谱－质谱联用LD50?板数致死剂量Logic check?逻辑检查LOQ?（Limit of Quantitation）?定量限LOCF，?Last observation carry forward?最近一次观察的结转Lost of follow up?失访Marketing approval/ authorization?上市许可证Matched pair?匹配配对Missing value?缺失值Mixed effect model?混合效应模式Monitor?监查员Monitoring?监查Monitoring report?监查报告MRT?平均滞留时间MS?质谱MS－MS?质谱－质谱联用MTD（Maximum Tolerated Dose）?最大耐受剂量Multicenter trial?多中心试验Multi-center trial?多中心试验New chemical entity，?NCE?新化学实体New drug application，?NDA?新药申请NMR?核磁共振谱Non-clinical study?非临床研究Non-inferiority?非劣效性Non-parametric statistics?非参数统计方法Obedience?依从性ODR?旋光光谱Open-blinding?非盲Open-label?非盲Optional titration?随意滴定Original medical record?原始医疗记录Outcome?结果Outcome assessment?结果指标评价Outcome measurement?结果指标Outlier?离群值Parallel group design?平行组设计Parameter estimation?参数估计Parametric statistics?参数统计方法Patient file?病人档案Patient history?病历Per protocol，?PP?符合方案集Placebo?安慰剂Placebo control?安慰剂对照Polytomies?多分类Power?检验效能Precision?精密度Preclinical study?临床前研究Primary endpoint?主要终点Primary variable?主要变量Principal investigator?主要研究者Principle investigator，?PI?主要研究者Product license，?PL?产品许可证Protocol?试验方案Protocol?试验方案Protocol amendment?方案补正Quality assurance unit，?QAU?质量保证部门Quality assurance，?QA?质量保证Quality control，?QC?质量控制Query list，?query form?应用疑问表Randomization?随机化Randomization?随机Range check?范围检查Rating scale?量表Regulatory authorities，?RA?监督管理部门Replication?可重复RSD?日内和日间相对标准差Run in?准备期Safety evaluation?安全性评价Safety set?安全性评价的数据集Sample size?样本含量Sample size?样本量，样本大小Scale of ordered categorical ratings?有序分类指标Secondary variable?次要变量Sequence?试验次序Serious adverse event，?SAE?严重不良事件Serious adverse reaction，?SAR?严重不良反应Seriousness?严重性Severity?严重程度Significant level?检验水准Simple randomization?简单随机Single blinding?单盲Single-blinding?单盲Site audit?试验机构稽查SOP?试验室的标准操作规程Source data verification，?SDV?原始数据核准Source data，?SD?原始数据Source document，?SD?原始文件Specificity?特异性Sponsor?申办者Sponsor-investigator?申办研究者Standard curve?标准曲线Standard operating procedure，?SOP?标准操作规程Statistic?统计量Statistical analysis plan?统计分析计划Statistical analysis plan?统计参数计划书Statistical analysis plan，?SAP?统计分析计划Statistical model?统计模型Statistical tables?统计分析表Stratified?分层Study audit?研究稽查Subgroup?亚组Sub-investigator?助理研究者Subject?受试者Subject diary?受试者日记Subject enrollment?受试者入选Subject enrollment log?受试者入选表Subject identification code，?SIC?受试者识别代码Subject recruitment?受试者招募Subject screening log?受试者筛选表Superiority?检验Survival analysis?生存分析SXRD?单晶X－射线衍射System audit?系统稽查T1/2?消除半衰期Target variable?目标变量T－BIL?总胆红素T－CHO?总胆固醇TG?热重分析TLC、HPLC?制备色谱Tmax?峰时间TP?总蛋白Transformation?变量变换Treatment group?试验组Trial error?试验误差Trial master file?试验总档案Trial objective?试验目的Trial site?试验场所Triple blinding?三盲Two one-side test?双单侧检验Unblinding?揭盲Unblinding?破盲Unexpected adverse event，?UAE?预料外不良事件UV－VIS?紫外－可见吸收光谱Variability?变异Variable?变量Visual analogy scale?直观类比打分法Visual check?人工检查Vulnerable subject?弱势受试者Wash-out?清洗期Washout period?洗脱期Well-being?福利，健康。