临床试验术语汉对照.docVIP

临床试验常用的英文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Blinding method盲法Blinding/ masking盲法，设盲Block分段Block size每段的长度BUN尿素氮Carryover effect延滞效应Case history病历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G