临床试验以及实验室中常见的中英文名词及缩写

1、厂F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CRCCli ni cal Research Coordin

2、ator临床研究协调者CRFCase Report Form病历报告表CROCon tract Research Organi zati on合同研究组织CSACli ni cal Study App licati on临床研究申请CTACli nical Trial App licati on临床试验申请CTXCli nical Trial Exe mp tio n临床试验免责CTPCli nical Trial P rotocol临床试验方案CTRCli nical Trial Report临床试验报告DSMBData Safety and mon itori ng Board数据安全及监

3、控委员会EDCElectro nic Data Cap ture1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药物非临床试验质量管理规范GMPGood Manu facturi ng Practice药品生产质量管理规范IBIn vestigatorBcSure研究者手册ICIn formed

4、 Consent知情同意ICFIn formed Consent Form知情同意书ICHIntern ati onal Conference on Harmoni zati on国际协调会议IDMIndependent Data Mon itori ng独立数据监察IDMCIndependent Data Mon itori ng Committee独立数据监察委员会IECIndependent Ethics Committee独立伦理委员会INDIn vestigatio nal New Drug新药临床研究IRBIn stituti onal Review Board机构审查委员会IVD

5、In Vitro Diag no stic体外诊断IVRSIn teractive Voice Response System互动语音应答系统MAMarketi ng App roval/Authorizatio n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 App licatio n新药申请NECNew Drug En tity新化学实体NIHNatio nal In stitutes of Health国家卫生研究所（美国）缩略语英文全称中文全称

6、PIPrincipal In vestigator主要研究者PLProduct Lice nse产品许可证PMAPre-market App roval (A pp licati 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严重不良事件SAPStatistic

7、al An alysis Plan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 Adm ini strati on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 Ide ntifica

8、ti on Code受试者识别代码SOPStan dard Op erat ing Procedure标准操作规程SPLStudy Personnel List研究人员名单SSLSubject Scree ning Log受试者筛选表T&RTest and Refere nee P roduct受试和参比试剂UAEUnexp ected 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 AuthoritiesWHO国

9、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 spending 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App roval批准Assista n

10、t 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 inspection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盲态检查Bli nding method盲法Bli ndin g/mask ing盲法/设盲Block层Block size每段的长度Carryover effect延滞效应Case

11、 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 app licationCTA临床试验申请Cli nical trial exemp tionCTX临床试验免责Cli nical trial p rotoco

12、l CT P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Comp aris on对照Comp lia nee依从性Comp osite variable复合变量Compu ter-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 tract/ a

13、greeme 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Descri ptive 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 relat

14、i 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 cap ture EDC电子数据采集系统Electro nic data pro cess ing EDP电子数据处理系统Emerge ncy envelope应急信件End point终占k、八、Endpoint Criteria终点指标Endpoint criteria/ measureme nt终点指标Equivale nee等效性Esse ntial Docume ntat

15、i on必需文件Ethics committee伦理委员会Excelle nt显效Exclusi on criteria排除标准Factorial desig n析因设计Failure无效失败Final point终点Fixed-dose p rocedure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, GCP药物临床

16、试验质量管理规范Good manu facture p ractice, GMP药品生产质量管理规范Good non-cli ni cal laboratory p ractice,药物非临床研究质量管理规范GhiLp seque ntial desig n成组序贯设计Health econo mic evaluati on, HEV健康经济学评价Hypo thesis test假设检验Hypo thesis test ing假设检验Imp roveme nt好转In clusi on Criteria入选表准英文全称中文全称In clusi on criteria入选标准Independen

17、t ethics committee lEC独立伦理委员会In formatio n consent formICF知情同意书In formati on Gatheri ng信息收集In formed consent IC知情同意In itial meet ing启动会议Inspection检察/视察In stituti on inspection机构检查In stituti on review board, IBR机构审查委员会Intention-to -reatITT意向性分析（统计学）In teractive voice response system IVRS互动式语音应答系统In t

18、erim 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 observatio n carry forward, LOCF最接近一次观察的结转LC MS液相色谱-质谱联用LD50板数致死剂量LOCF, Last observati on carry forward最近一次观察的结转Logic check逻辑检查LOQ

19、 (Limit of Qua ntizati on)定量限Lost of follow up失访Marketi ng app roval/ authorizati on上市许可证Matched p air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监查Mon itori ng Plan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多中心试

20、验英文全称中文全称New chemical en tityNCE新化学实体New drug app licationNDA新药申请NMR核磁共振谱No n-cii nical Study非临床研究Non-i nferiority非劣效性Non-p arametric statistics非参数统计方法Obedie nee依从性ODR旋光光谱Open-label非盲Op ti 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P arallel group desig n平行组设计P arameter estimati on参数估计P arametric statistics参数统计方法P atie nt file病人档案P atie nt history病历Per p rotocol PP符合方案集P lacebo安慰剂P lacebo con trol安慰剂对照Po lytomies多分类Po wer检验效能P recisio n精密度P recli nical study临床前研究P rimary endpoint主要终点Primary variabl

22、e主要变量Principle in vestigatorPI主要研究者P roduct lice nse PL产品许可证P rotocol试验方案P rotocol 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 listquery form应用疑冋表Ran domizati on随机Range check范围检查Rati ng scale量表Refere nee Product参比制剂Regulatory authorit

23、ies RA监督管理部门Rep licati 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Samp le 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 reaction SAR严重不良反应Serious ness严重性Severity严重程度Severity严重程度Signi

24、fica nt level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Sp ecificity特异性Sponsor申办者Sponsor-in vestigator申办研究者Stan dard curve标准曲线Stan dard op erati ng pro cedure SOP标准操作规程Statistic统计量Statistic

25、al an alysis plan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Subgro up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 codeSIC受试者识别代码Subj

26、ect Ide ntificati on Code List受试者识别代码表Subject Recruitme nt受试者招募Subject scree ning log受试者筛选表Sup eriority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 P roduct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 grou

27、p试验组Trial error试验误差Trial 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三盲英文全称中文全称Two on e-side test双单侧检验Un-bli nding揭盲Unexp ected 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 subj

28、ect弱势受试者Wash-out洗脱Washout p eriod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 blood cell cou nt白细胞计数GR% gran ulocyte中性粒细胞白分比LY% lymp hocyte淋巴细胞百分比MID%中值细胞百分比EOS% eosimo phil嗜酸性粒细胞百分比AL% allergy lymp hocyte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 hemoglobi n血红蛋白HCT hematocrit红细胞比积红细胞比积MCV mean corp usula

29、r volume平均红细胞体积MCH mean corpu sular hemoglob in平均红细胞血红蛋白含量MCHC mea n corpu scular hemoglob in concern trati on平均红细胞血红蛋白浓度RDW red blood cell volume distributi on width红细胞分布宽度变异P LT/B PC p latelet cou nt/blood p latelet count血小板计数MPV mea n p latelet volume平均血小板体积PCT plateletocrit血小板比积PDW platelet dist

30、ribution 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 sp ecific gravity比重PRO p rotein尿蛋白BLD blood隐血BIL bilirubin尿胆红素URO urobil inogen尿胆原WBC white blood cell白细胞addish 计数 addish count艾迪氏计数/HP high po wer objective每高倍视野/LP low po wer objective每低倍视野OB occult blood test大便隐血试验体液常规CSF cerebr

31、os pinal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 bilirub in直接胆红素TP total p rotein总蛋白ALB albumin白蛋白GLOB globulin球蛋白UREA urea尿素CREA creati nine肌肝UA uric acid尿酸GLU glucose血糖ALT ala nine amiotra nsferase丙氨酸氨基转移酶AST asp artate aminotran sferase门冬氨酸氨基转移酶GGT Y -glutamyl transpeptadase谷

32、氨酰转肽酶CK creat ine kin ase肌酸肌酶CK-MB creati ne kin ase-MB肌酸肌酶同工酶LDH lactate dehydroge nase乳酸脱氢酶a -HBD a -hydroxybutyric dehydrogenasea 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-de nsity lipop rote in cholesterol高密度脂蛋白LDL-c low-de nsity lipop rote in cholesterol低密度脂蛋白VLD