临床试验以与实验室中常见的中英文名词与缩写

1、痂L)佰荣泰华XZJBioTell Consulting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学习参考学习参考药物临床试验英文缩写缩略语英文全称中文全称ADEAdverse Drug Event药物不良事件ADRAdverse Drug Reaction药物不艮反应AEAdverse Event不艮事件AIAssistant Investigator助理研究者BMIBody Mass Index体质指数CICo-investigator合作研究者COICoordinating Investigator协调研究者CRCClinical Research Coordina

2、tor临床研究协调者CRFCase Report Form病历报告表CROContract Research Organization合同研究组织CSAClinical Study Application临床研究申请CTAClinical Trial Application临床试验申请CTXClinical Trial Exemption临床试验免责CTPClinical Trial Protocol临床试验方案CTRClinical Trial Report临床试验报告DSMBData Safety and monitoring Board数据安全及监控委员会EDCElectronic Da

3、ta Capture电子数据采集系统EDPElectronic Data Processing电子数据处理系统FDAFood and Drug Administration美国食品与药品管理局FRFinal Report总结报告GCPGood Clinical Practice药物临床试验质量管理规范GCPGood Laboratory Practice药物非临床试验质量管理规范GMPGood Manufacturing Practice药品生产质量管理规范IBInvestigator ' s Brochure研究者手册ICInformed Consent知情同意ICFInformed

4、 Consent Form知情同意书ICHInternational Conference on国际协调会议IDMHdependenioData Monitoring独立数据监察IDMCIndependent Data Monitoring独立数据监察委员会一IECCompmnteent 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 Response System

5、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）缩略语英文全称中文全称PIPrincipal Investigator主要研究着PLProduct License产品许可证PMAPre-market Approval (

6、Application)上而前许可（申请）PSIStatisticians in the Pharmaceutical制药业统计学家协会QAQndusyy 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统计分析计划一SARSerious Adverse Reaction严重不良反应SDSource Data/Document原始数据/文件SDSubject

7、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受试后选表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SSLSubject Screening Log受

8、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 ofDrug Regulatory AuthoritiesWHO!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 drug reaction, ADR药物不良反应Adverse event, AE不良事

9、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 )近似致夕匕剂量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稳态血药浓度一时间曲线卜面积Audit稽查Audit or inspection稽查/视察Audit report稽查报告Auditor稽查员Bias偏

10、性偏倚Bioequivalence生物等效应Blank control空白对照Blind codes编制盲底Blind review自态审核Blind review盲态检查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分类及重英乂全称中乂全称Cav平均浓度CD圆二色谱CL清除率Clinical equivalence临床等

11、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 applicationCTA临床试验申请Clinical trial exemptionCTX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

12、 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肌酎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Datab

13、ase建立数据库Descriptive statistical analysis描述性统计分析DF波动系统Dichotomies二分类DiviationBitDocumentation记录/文件英乂全称中乂全称Dose-reaction relation剂量反班天系Double dummy双模拟Double dummy technique双百双馍拟技不Drop out脱洛DSC差不扫描热量计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 envel

14、ope应急信件End point终点Endpoint Criteria终点指标Endpoint criteria/ measurement终点指标Equivalence等效性Essential Documentation必需文件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

15、- 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,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

16、假设检验Improvement好转Inclusion Criteria入选表准英文全称中文全称Inclusion criteria入选标准Independent ethics committeeIEC独立伦理委员会Information consent formICF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检察/视察Institution inspection机构检查Institution review board, IBR机构审查委员会Intention-to trea

17、tITT意向性分析（统计学）Interactive voice response systemIVRS互动式语音应答系统Interim analysis期中分析International Conference of Harmonization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Investigator研究者Investigator ' s brochure, IB研究者手册Last observation carry forward, LOCF最接次观察的结转LC MS液相色谱-质谱联用LD50板数致夕匕剂量LOCF, L

18、ast observation carry forward最次观察的结转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Monitoring Report监察报告MRT平均滞留时间MS质谱MS- MS质谱-质谱联用MTD( Maximum Toler

19、ated Dose )取大耐受剂里Multi-center Trial多中心试验英乂全称中乂全称New chemical entity NCE新化字头体New drug applicationNDA新约甲请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-label非盲Optional titration随意滴定Original medical record原始医疗记录Outcome结果Outcome Assessment结果评价Ou

20、tcome 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 v

21、ariable主要变量Principle investigatorPI主要研究者Product license PL产品许可证Protocol试验方案Protocol Amendments修正案Quality assurance QA质量保证Quality assurance unit QAU质量保证部门Quality control QC质量控制英乂全称中乂全称Query list query form四用疑问表Randomization随机Range check范围检查Rating scaleReference Product参比制剂Regulatory authoritiesRA监督管理

22、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样本量样本大小Scale of ordered categorical ratings后序分类指标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Severity严重程度Significant level检验水准Sim

23、ple Randomization简单随机Single blinding单自Site audit试验机构稽查SOP试验室的标准操作规程Source data SD原始数据Source data verification SDV原始数据核准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 procedureSOP标准操作规程Statistic统计量Statistical analysis plan统计分析计划Statistical

24、model统计模型Statistical tables统计分析表英乂全称中乂全称Stratified分层Study Audit研究情食Study audit研究情食Study Site研究中心Subgroup亚组Sub-investigator助理研究者Subject受试者Subject受试者Subject diary受试者日记Subject Enrollment受试者入选Subject enrollment log受试着人选表Subject identification codeSIC受试者识别代码Subject Identification Code List受试者识别代码表Subject

25、 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System Audit系统稽查T1/2消除半衰期Target variable目标变量TBIL总胆红素TCHO总胆固醇Test Product受试制剂TG热重分析TLG 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 Initial Meeting试验启动会议Trial Mast

26、er File试验总档案Trial objective试验目的Trial site试验场所Triple blinding二盲英文全称中文全称Two one-side test双单侧检验Un-blinding揭盲Unexpected adverse eventUAE预料外不良事件UW 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洗脱Washout period洗脱期实验室检查英文缩写英文全称中文全称血常规WBC white

27、blood cell count白细胞计数GR% granulocyte中性粒细胞白分比LY% lymphocyte淋巴细胞百分比MID%中值细胞百分比EOS% eosimophil嗜酸性粒细胞百分比AL% allergy lymphocyte变异淋巴细胞百分比ST%中性杆状粒细胞百分比RBC red blood cell红细胞计数HGB hemoglobin血红蛋白HCT hematocrit 红细胞比积红细胞比积MCV mean corpusular volume平均红细胞体积MCH mean corpusular hemoglobin平均红细胞血红蛋白含量MCHC mean corpus

28、cular hemoglobin平均红细胞血红蛋白浓度concentrationRDW red blood cell volume distribution红细胞分布宽度变异wLThBPC platelet count/blood platelet血小板计数MPVtmean platelet volume平均血小板体积PCT plateletocrit血小板比积PDW platelet distribution width血小板分布宽度尿便常规PH acidity酸碱度NIT nitrite亚硝酸盐GLU glucose尿糖SG specific gravity比重PRO protein尿蛋白

29、BLD blood隐血BIL bilirubin尿胆红素URO urobilinogen尿胆原WBC white blood cell白细胞addish 计数 addish count艾迪氏计数/HP high power objective每高倍视野/LP low power objective每低倍视野OB occult blood test大便隐血试验体液常规CSF cerebrospinal脑积夜Pandy pandy庞氏试验英文全称中文全称生化检验TB total bilirubin总胆红素DB direct bilirubin直接胆红素TP total protein总蛋白ALB

30、albumin白蛋白GLOB globulin球蛋白UREA ureaCREA creatinine肌肝UA uric acid尿酸GLU glucose血糖ALT alanine amiotransferase丙氨酸氨基转移酶AST aspartate aminotransferase门冬氨酸氨基转移酶GGT 丫 -glutamyl transpeptadase谷氨酰转肽酶CK creatine kinase肌酸肌酶CK-MB creatine kinase-MB肌酸肌酶同工酶LDH lactate dehydrogenase乳酸脱氢酶a -HBD a -hydroxybutyric dehydrogenase“-羟丁酸脱氢酶AMY serum amylase血淀粉酶TG triglyceride肝油三脂CHOL cholesterol胆固醇HDL-c high-density lipoprotein高密度脂蛋白LDLesteW-density li