临床试验以及实验室中常见的中英文名词及缩写.docx

1、临床试验以及实验室中常见的中英文名词及缩写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药物不良反应AEAdverse Event不良事件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 Coordinator临床研究协调者CRFCa

2、se 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 Data Capture电子数据采

3、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IBInvestigators Brochure研究者手册ICInformed Consent知情同意ICFInformed Consent Form知情同意书ICHI

4、nternational 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 Response Syst

5、em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主要研究者PLProduct License产品许可证PMAPre-market Approval

6、 (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/Document原始数据/文件

7、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SSLSubject Scr

8、eening 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 ofDrug 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 drug reaction, ADR药物不良反应Adverse eve

9、nt, 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B

10、ias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分类变量英文全称中文全称Cav平均浓度CD圆二色谱CL清除率Clinical equivalen

11、ce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-assiste

12、d 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

13、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记录文件英文全称中文全称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 EDC电子数据采集系统Electronic data processing EDP电子数据处理系统Emergency e

14、nvelope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GCFTIR气相色谱傅利叶红外联用

15、GCMS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 test

16、ing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 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检察/视察Institution inspection机构检查Institution review board, IBR机构审查委员会Intention-to

17、 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International Conference of HarmonizationICH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Investigators brochure, IB研究者手册Last observation carry forward, LOCF最接近一次观察的结转LCMS液相色谱质谱联用LD50板数致死剂量LOC

18、F, Last observation carry forward最近一次观察的结转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MSMS质谱质谱联用MTD（Maximum Tol

19、erated Dose）最大耐受剂量Multi-center Trial多中心试验英文全称中文全称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-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

20、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

21、 variable主要变量Principle investigator PI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质量控制英文全称中文全称Query list query form应用疑问表Randomization随机Range check范围检查Rating scale量表Reference Product参比制剂Regulatory authorities

22、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Severity严重程度Significant level检

23、验水准Simple Randomization简单随机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 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 procedure SOP标准操作规程Statistic统计量Statistical analysis plan统计分析计划Stati

24、stical model统计模型Statistical tables统计分析表英文全称中文全称Stratified分层Study Audit研究稽查Study audit研究稽查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受试者入选表Subject identification code SIC受试者识别代码Subject Identification Code List受试者识别代码

25、表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 Initial Meeting试验启动会议Tr

26、ial Master File试验总档案Trial objective试验目的Trial site试验场所Triple blinding三盲英文全称中文全称Two one-side test双单侧检验Un-blinding揭盲Unexpected adverse event UAE预料外不良事件UVVIS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WB

27、C white blood cell count白细胞计数GR% granulocyte中性粒细胞百分比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 corpuscular hemoglobin concerntration平均红细胞血红蛋白浓度RDW red blood cell volume distribution width红细胞分布宽度变异PLT/BPC platelet count/blood platelet count血小板计数MPV mean platelet volume平均血小板体积PCT p