临床研究缩写.docx

1、临床研究缩写ICHInternational Conference on Harmonization国际协调会议IDMIndependent Data Monitoring独立数据监察IDMCIndependent Data Monitoring Committee独立数据监察委员会IECIndependent Ethics Committee独立伦理委员会INDInvestigational New Drug新药临床研究IRBInstitutional Review Board机构审查委员会IVDIn Vitro Diagnostic体外诊断IVRSInteractive Voice Res

2、ponse System互动语音应答系统MAMarketing Approval/Authorization上市许可证MCAMedicines Control Agency英国药品监督局MHWMinistry of Health and Welfare日本卫生福利部NDANew Drug Application新药申请NECNew Drug Entity新化学实体NIHNational Institutes of Health国家卫生研究所（美国）PIPrincipal Investigator主要研究者PLProduct License产品许可证缩略语英文全称中文全称PMAPre-marke

3、t Approval（Application）上市前许可（申请）PSIStatisticians in the Pharmaceutical Industry制药业统计学家协会QAQuality Assurance质量保证QCQuality Control质量控制RARegulatory Authorities监督管理部门SASite Assessment现场评估SAESerious Adverse Event严重不良事件SAPStatistical Analysis Plan统计分析计划SARSerious Adverse Reaction严重不良反应SDSource Data/Docume

4、nt原始数据/文件SDSubject Diary受试者日记SFDAState Food and Drug Administration国家食品药品监督管理局SDVSource Data Verification原始数据核准SELSubject Enrollment Log受试者入选表SISub-investigator助理研究者SISponsor-Investigator申办研究者SICSubject Identification Code受试者识别代码SOPStandard Operating Procedure标准操作规程SPLStudy Personnel List研究人员名单SSLSu

5、bject Screening Log受试者筛选表T&RTest and Reference Product受试和参比试剂UAEUnexpected Adverse Event预料外不良事件WHOWorld Health Organization世界卫生组织WHO-ICDRAWHO International Conference of Drug Regulatory AuthoritiesWHO国际药品管理当局会议药物临床试验英文缩写英文全称中文全称Accuracy准确度Active control，AC阳性对照 活性对照Adverse medical events不良医学事件Adverse

6、 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丙氨酸氨基转移酶Analysis sets统计分析的数据集Approval批准Assistant investigator助理研究者AST天门冬酸氨基转移酶ATR衰竭全反射法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

7、对照Blind codes编制盲底Blind review盲态审核/盲法检查Blinding method盲法Blinding/masking盲法/设盲Block层Block size每段的长度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CD圆二色谱CL清除率Clincal equivalence临床等效应Clinical study临床研究Clinical study report临床试验的总结报告Clinica

8、l trial application CTA临床试验申请Clinical trial/study report临床试验报告Cmax峰浓度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/agreement协议/合同Control group对照组Coordinating committee协调委员会Crea肌酐Cros

9、sover 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 dummy双模拟Double dummy technique双盲双模拟技术Drop out脱落DSC差示扫描热量计Effectiveness疗效Electronic data capture

10、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

11、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-质谱连用Generic drug通用名药Global assessment variable全局评价变量GLU血糖Good non-clincal 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Improvement好转Inclusion criteria

12、入选标准Independent ethic committee， IEC独立伦理委员会Information consent form， ICF知情同意书Information gathering信息收集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，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I

13、nternational 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Investigational product试验药物Last observation carry forward，LOCF最近一次观察的结转LC-MS液相色谱-质谱联用LD50半数致死剂量Logic check逻辑检查LOQ（limit of quantization）定量限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监察员Monitoring监查Monitoring plan监察计划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Multi-center trial多中心试验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-label非盲Optiona