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(3/ole)佰荣泰华BioTell 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药物临床试验英文缩写缩略语英文全称中文全称ADEAdverse Drug Eve nt药物不良事件ADRAdverse Drug React ion药物不良反应AEAdverse Eve nt不良事件AIAssista nt In vestigator助理研究者BMIBody Mass In dex体质指数CICo-i nvestigator合作研究者COICoordin at ing In vestigator协调研究者CRCCl

2、i ni cal Research Coordin ator临床研究协调者CRFCase Report Form病历报告表CROCon tract Research Orga ni zati on合同研究组织CSACli ni cal Study Applicati on临床研究申请CTAClinical Trial Application临床试验申请CTXCli nical Trial Exemptio n临床试验免责CTPCli nical Trial Protocol临床试验方案CTRCli nical Trial Report临床试验报告DSMBData Safety and mon

3、itori ng Board数据安全及监控委员会EDCElectro nic Data Capture电子数据采集系统EDPElectr onic Data Process ing电子数据处理系统FDAFood and Drug Adm ini strati on美国食品与药品管理局FRFinal Report总结报告GCPGood Cli ni cal Practice药物临床试验质量管理规范GCPGood Laboratory Practice药物非临床试验质里官理规氾GMPGood Manu facturi ng Practice药品生产质量管理规范IBIn vestigator Bch

4、ure研究者手册ICIn formed Consent知情同意ICFIn formed Consent Form知情冋意书ICHIntern ati onal Conference on Harmoni zati on国际协调会议IDMIn depe ndent Data Mon itori ng独立数据监察IDMCIndependent Data Monitoring Committee独立数据监察委员会 IECIn depe ndent Ethics Committee独立伦理委员会INDIn vestigatio nal New Drug新药临床研究IRBInstitutional Re

5、view Board机构审查委员会IVDIn Vitro Diag no stic体外诊断IVRSIn teractive Voice Resp onse System互动语音应答系统MAMarketing A pproval/Authorization上市许可证MCAMedici nes Con trol Age ncy英国药品监督局MHWMi nistry of Health and Welfare日本卫生福利部NDANew Drug Applicatio n新药申请 1NECNew Drug En tity新化学实体NIHNational Institutes of Health国家卫生

6、研究所（美国）缩略语英文全称中文全称PIPrincipal Investigator主要研究者PLProduct Lice nse产品许可证PMAPre-market Approval (Applicati on)上市前许可（申请）PSIStatisticia ns in the Pharmaceutical In dustry制药业统计学家协会QAQuality Assura nee质量保证QCQuality Con trol质量控制RARegulatory Authorities监督管理部门SASite Assessme nt现场评估SAESerious Adverse Event严重不良

7、事件SAPStatistical An alysis Pla n统计分析计划SARSerious Adverse React ion严重不良反应SDSource Data/Docume 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 Verificati on原始数据核准SELSubject En rollme nt Log受试者入选表SISub-i nvestigator助理研究者SISponsor-In vestigator申办研究者SICSubject

8、 Ide ntificati on Code受试者识别代码SOPStan dard Operat ing Procedure标准操作规程SPLStudy Personnel List研究人员名单SSLSubject Scree ning Log受试者帅选表T&RTest and Refere nee Product受试和参比试剂UAEUn expected Adverse Event预料外不良事件WHOWorld Health Orga ni zatio n世界卫生组织WHO-ICDRAWHO Intern ati onal Conference ofDrug Regulatory Autho

9、ritiesWHO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 con trol, AC阳性对照活性对照Adverse drug react ion, ADR药物不良反应Adverse event, AE不良事件Adverse medical events不良医学事件Adverse react ion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 spe nding function消耗函数ALT丙氨酸氨基转换酶An alysis sets统计分析的数据集Approval批

10、准Assista nt in vestigator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 in spect ion稽查/视察Audit report稽查报告Auditor稽查员Bias偏性偏倚Bioequivale nee生物等效应Bla nk con trol空白对照Bli nd codes编制盲底Bli nd review盲态审核Bli nd review盲态检杳Bli nding method盲法Bli ndin g/mask ing盲法/设盲Block层Block size每段的长度Carryover ef

11、fect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Cli nical equivale nee临床等效应Cli nical study临床研究Cli nical study report临床试验的总结报告Cli nical trial临床试验Cli nical trial application CTA临床试验申请Cli nical trial exemption CTX临床试验免责Cli nical tr

12、ial protocol CTP临床试验方案Cli nical trial/ study report临床试验报告Cmax峰浓度Co-i nvestigator合作研究者Comparis on对照Complia nee依从性Composite variable复合变量Computer-assisted trial desig n CATD计算机辅助试验设计Con fide nee in terval可信区间Con fide nee level置信水平Con siste ncy test一致性检验Con tract research orga ni zatio n CRO合同研究组织Con tr

13、act/ agreeme nt协议/合同Con trol group对照组Coordin at ing committee协调委员会Crea肌酐CRF(case report form)病例报告表Crossover desig n交叉设计Cross-over Study交叉研究Css稳浓度Cure痊愈Data man ageme nt数据管理Database建立数据库Descriptive statistical an alysis描述性统计分析DF波动系统Dichotomies二分类Diviatio n偏差Docume ntati on记录/文件英文全称中文全称Dose-react ion

14、relati on剂量反应关系Double dummy双模拟Double dummy tech nique双盲双模拟技术Drop out脱落DSC差示扫描热量计Effective ness疗效Electro nic data capture EDC电子数据采集系统Electro nic data process ing EDP电子数据处理系统Emerge ncy en velope应急信件End point终占八、En dpo int Criteria终点指标En dpo int criteria/ measureme nt终点指标Equivale nee等效性Esse ntial Docum

15、e ntati on必需文件Ethics committee伦理委员会Excelle nt显效Exclusion criteria排除标准Factorial desig n析因设计Failure无效失败Final point终占八、Fixed-dose procedure固定剂量法Forced titrati on强制滴定Full an alysis 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Gen eric drug通用名药Global assessme nt variable全局评价变量GLU血糖Good cli ni cal practice, G

16、CP药物临床试验质量管理规范Good manu facture practice, GMP药品生产质量管理规范Good non-cli ni cal laboratory practice,药物非临床研究质量管理规范Group seque ntial desig n成组序贯设计Health econo mic evaluati on, HEV健康经济学评价Hypothesis test假设检验Hypothesis test ing假设检验Improveme nt好转Inclusion Criteria入选表准英文全称中文全称Inclusion criteria入选标准In depe ndent

17、 ethics committee IEC独立伦理委员会In formatio n consent form ICF知情同意书Information Gathering信息收集In formed consent IC知情同意In itial meet ing启动会议In spect ion检察/视察In stituti on in spect ion机构检查In stituti on review board, IBR机构审查委员会Intention-to -reat ITT意向性分析（统计学）In teractive voice resp onse system IVRS互动式语音应答系统I

18、n terim an alysis期中分析Intern ati onal Conference of Harmoni zati onICH人用药品注册技术要求国际技术协调会 国际协调会议In vestigati onal Product试验药物In vestigator研究者In vestigator brochure, IB研究者手册Last observati on carry forward, LOCF最接近一次观祭的结转LC MS液相色谱-质谱联用LD50板数致死剂量LOCF, Last observati on carry forward最近一次观祭的结转Logic check逻辑检

19、查LOQ (Limit of Qua ntizati on)定量限Lost of follow up失访Marketing approval/ authorization上市许可证Matched pair匹配配对Miss ing value缺失值Mixed effect model混合效应模式Mo nitor监察员Mon itori ng监杳Mon itori ng Pla n监察计划Mon itori ng 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 Tolerated Dose )最大耐受剂量Multi-ce nter Trial多中心

20、试验英文全称中文全称New chemical en tity NCE新化学实体New drug application NDA新药申请NMR核磁共振谱No n-cli nical Study非临床研究Non-i nferiority非劣效性Non-parametric statistics非参数统计方法Obedie nee依从性ODR旋光光谱Open-label非盲Opti onal titrati on随意滴定Origi nal medical record原始医疗记录Outcome结果Outcome Assessme nt结果评价Outcome assessme nt结果指标评价Outco

21、me measureme nt结果指标Outlier离群值Parallel group desig n平行组设计Parameter estimati on参数估计Parametric statistics参数统计方法Patient file病人档案Patie nt history病历Per protocol PP符合方案集Placebo安慰剂Placebo con trol安慰剂对照Polytomies多分类Power检验效能Precisi on精密度Precli nical study临床前研究Primary en dpo int主要终点Primary variable主要变量Prin ci

22、ple in vestigator PI主要研究者Product lice nse PL产品许可证Protocol试验方案Protocol Ame ndme nts修正案Quality assura nee QA质量保证Quality assura nee un it 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应用疑冋表Ran domizati on随机Range check范围检查Rati ng scale里表Refere nee Product参比制剂Regulatory authorities RA监督管理部门

23、Replicati on可重复RSD日内和日间相对标准差Run in准备期Safety evaluati on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 rat ings有序分类指标Secon dary variable次要变量Sequenee试验次序Serious adverse eve nt SAE严重不良事件Serious adverse react ion SAR严重不良反应Serious ness严重性Severity严重程度Severity严重程度Signi fica nt level

24、检验水准Simple Ran domizati on简单随机Si ngle bli nding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 verificati on SDV原始数据核准Source docume nt SD原始文件Specificity特异性Sponsor申办者Sponsor-in vestigator申办研究者Stan dard curve标准曲线Stan dard operati ng procedure SOP标准操作规程Statistic统计量Statistical an alysis pla

25、 n统计分析计划Statistical 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-i nvestigator助理研究者Subject受试者Subject受试者Subject diary受试者日记Subject En rollme nt受试者入选Subject en rollme nt log受试者入选表Subject ide ntificati on code SIC受试者识别代码Subject Identificat

26、ion Code List受试者识别代码表Subject Recruitme nt受试者招募Subject scree ning log受试者师选表Superiority检验Survival an alysis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T BIL总胆红素T CHO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Tran sformatio n变量变换Treatme nt group试验组Trial error试验误差T

27、rial In itial Meet ing试验启动会议Trial Master File试验总档案Trial objective试验目的Trial site试验场所Triple bli nding二盲英文全称中文全称Two on e-side test双单侧检验Un-bli nding揭盲Un expected 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 an alogy scale直观类比打分法Visual check人工检查Vuln erable subject弱势受试者Wash-out洗脱Washout period洗脱期实验室检查英文缩与英文全称中文全称血常规WBC white blood cell cou nt白细胞计数GR% gran ulocyte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