臨床試驗(yàn)以及實(shí)驗(yàn)室中常見(jiàn)地中英文名詞及縮寫(xiě)

1、0o】e)佰榮泰華XJ 2 BioTell Consulting中國(guó)創(chuàng)新藥咨詢(xún)與服務(wù)先鋒CRO臨床試驗(yàn)以及實(shí)驗(yàn)室中常見(jiàn)的英文縮寫(xiě)藥物臨床試驗(yàn)英文縮寫(xiě)縮略語(yǔ)英文全稱(chēng)中文全稱(chēng)ADEAdverse Drug Eve nt藥物不良事件ADRAdverse Drug React ion藥物不良反應(yīng)AEAdverse Eve nt不良事件AIAssista nt In vestigator助理研究者BMIBody Mass In dex體質(zhì)指數(shù)CICo-i nvestigator合作研究者COICoordin at ing In vestigator協(xié)調(diào)研究者CRCCli ni cal Research

2、Coordin ator臨床研究協(xié)調(diào)者CRFCase Report Form病歷報(bào)告表CROCon tract Research Orga ni zati on合同研究組織CSACli ni cal Study Applicati on臨床研究申請(qǐng)CTAClinical Trial Application臨床試驗(yàn)申請(qǐng)CTXCli nical Trial Exemptio n臨床試驗(yàn)免責(zé)CTPCli nical Trial Protocol臨床試驗(yàn)方案CTRCli nical Trial Report臨床試驗(yàn)報(bào)告DSMBData Safety and mon itori ng Board數(shù)據(jù)安全

3、及監(jiān)控委員會(huì)EDCElectro nic Data Capture電子數(shù)據(jù)采集系統(tǒng)EDPElectr onic Data Process ing電子數(shù)據(jù)處理系統(tǒng)FDAFood and Drug Adm ini strati on美國(guó)食品與藥品管理局FRFinal Report總結(jié)報(bào)告GCPGood Cli ni cal Practice藥物臨床試驗(yàn)質(zhì)量管理規(guī)范GCPGood Laboratory Practice藥物非臨床試驗(yàn)質(zhì)里官理規(guī)氾GMPGood Manu facturi ng Practice藥品生產(chǎn)質(zhì)量管理規(guī)范IBInvestigator' s Brochure研究者手冊(cè)IC

4、In formed Consent知情同意ICFIn formed Consent Form知情冋意書(shū)ICHIntern ati onal Conference on國(guó)際協(xié)調(diào)會(huì)議IDMtndemeRdeWPD ata Mo nitori ng獨(dú)立數(shù)據(jù)監(jiān)察IDMCIn depe ndent Data Mon itori ng獨(dú)立數(shù)據(jù)監(jiān)察委員會(huì)IECCidmndent Ethics Committee獨(dú)立倫理委員會(huì)INDIn vestigatio nal New Drug新藥臨床研究IRBInstitutional Review Board機(jī)構(gòu)審查委員會(huì)IVDIn Vitro Diag no st

5、ic體外診斷IVRSIn teractive Voice Resp onse System互動(dòng)語(yǔ)音應(yīng)答系統(tǒng)MAMarketi ng Approval/Authorizati on上市許可證MCAMedici nes Con trol Age ncy英國(guó)藥品監(jiān)督局MHWMi nistry of Health and Welfare日本衛(wèi)生福利部NDANew Drug Applicatio n新藥申請(qǐng)1NECNew Drug En tity新化學(xué)實(shí)體NIHNational Institutes of Health國(guó)家衛(wèi)生研究所（美國(guó)）縮略語(yǔ)英文全稱(chēng)中文全稱(chēng)PIPrincipal Investiga

6、tor主要研究者PLProduct Lice nse產(chǎn)品許可證PMAPre-market Approval (Applicati on)上市前許可（申請(qǐng)）PSIStatisticia ns in the Pharmaceutical制藥業(yè)統(tǒng)計(jì)學(xué)家協(xié)會(huì)QAQdafi Assuranee質(zhì)量保證QCQuality Con trol質(zhì)量控制RARegulatory Authorities監(jiān)督管理部門(mén)SASite Assessme nt現(xiàn)場(chǎng)評(píng)估SAESerious Adverse Event嚴(yán)重不良事件SAPStatistical An alysis Pla n統(tǒng)計(jì)分析計(jì)劃SARSerious Adv

7、erse React ion嚴(yán)重不良反應(yīng)SDSource Data/Docume nt原始數(shù)據(jù)/文件SDSubject Diary受試者日記SFDAState Food and Drug Administration國(guó)家食品藥品監(jiān)督管理局SDVSource Data Verificati on原始數(shù)據(jù)核準(zhǔn)SELSubject En rollme nt Log受試者入選表SISub-i nvestigator助理研究者SISponsor-In vestigator申辦研究者SICSubject Ide ntificati on Code受試者識(shí)別代碼SOPStan dard Operat ing

8、 Procedure標(biāo)準(zhǔn)操作規(guī)程SPLStudy Personnel List研究人員名單SSLSubject Scree ning Log受試者帥選表T&RTest and Refere nee Product受試和參比試劑UAEUn expected Adverse Event預(yù)料外不良事件WHOWorld Health Orga ni zatio n世界衛(wèi)生組織WHO-ICDRAWHO Intern ati onal Conference ofDrug Regulatory AuthoritiesWHC國(guó)際藥品管理當(dāng)局會(huì)議藥物臨床試驗(yàn)英文縮寫(xiě)英文全稱(chēng)中文全稱(chēng)Accuracy準(zhǔn)確度

9、Active con trol, AC陽(yáng)性對(duì)照活性對(duì)照Adverse drug react ion, ADR藥物不良反應(yīng)Adverse event, AE不良事件Adverse medical events不良醫(yī)學(xué)事件Adverse react ion藥物不良反應(yīng)Alb白蛋白ALD (Approximate Lethal Dose )近似致死劑量ALP堿性磷酸酶Alpha spe nding function消耗函數(shù)ALT丙氨酸氨基轉(zhuǎn)換酶An alysis sets統(tǒng)計(jì)分析的數(shù)據(jù)集Approval批準(zhǔn)Assista nt in vestigator助理研究者AST天門(mén)冬酸氨基轉(zhuǎn)換酶ATR衰減全

10、反射法AUCss穩(wěn)態(tài)血藥濃度時(shí)間曲線(xiàn)下面積Audit稽查Audit or in spect ion稽查/視察Audit report稽查報(bào)告Auditor稽查員Bias偏性偏倚Bioequivale nee生物等效應(yīng)Bla nk con trol空白對(duì)照Bli nd codes編制盲底Bli nd review盲態(tài)審核Bli nd review盲態(tài)檢杳Bli nding method盲法Bli ndin g/mask ing盲法/設(shè)盲Block層Block size每段的長(zhǎng)度Carryover effect延滯效應(yīng)Case history病歷Case report form/ case rec

11、ord form CRF病例報(bào)告表病例記錄表Categorical variable分類(lèi)變量英文全稱(chēng)中文全稱(chēng)Cav平均濃度CD圓二色譜CL清除率Cli nical equivale nee臨床等效應(yīng)Cli nical study臨床研究Cli nical study report臨床試驗(yàn)的總結(jié)報(bào)告Cli nical trial臨床試驗(yàn)Cli nical trial applicationCTA臨床試驗(yàn)申請(qǐng)Cli nical trial exemptionCTX臨床試驗(yàn)免責(zé)Cli nical trial protocol CTP臨床試驗(yàn)方案Cli nical trial/ study repor

12、t臨床試驗(yàn)報(bào)告Cmax峰濃度Co-i nvestigator合作研究者Comparis on對(duì)照Complia nee依從性Composite variable復(fù)合變量Computer-assisted trial desig n CATD計(jì)算機(jī)輔助試驗(yàn)設(shè)計(jì)Con fide nee in terval可信區(qū)間Con fide nee level置信水平Con siste ncy test一致性檢驗(yàn)Con tract research orga ni zatio n CRO合同研究組織Con tract/ agreeme nt協(xié)議/合同Con trol group對(duì)照組Coordin at in

13、g committee協(xié)調(diào)委員會(huì)Crea肌酐CRF(case report form)病例報(bào)告表Crossover desig n交叉設(shè)計(jì)Cross-over Study交叉研究Css穩(wěn)濃度Cure痊愈Data man ageme nt數(shù)據(jù)管理Database建立數(shù)據(jù)庫(kù)Descriptive statistical an alysis描述性統(tǒng)計(jì)分析DF波動(dòng)系統(tǒng)Dichotomies二分類(lèi)Diviatio n偏差Docume ntati on記錄/文件英文全稱(chēng)中文全稱(chēng)Dose-react ion relati on劑量一反應(yīng)天糸Double dummy雙模擬Double dummy tech n

14、ique雙盲雙模擬技術(shù)Drop out脫落DSC差示掃描熱量計(jì)Effective ness療效Electro nic data capture EDC電子數(shù)據(jù)采集糸統(tǒng)Electro nic data process ing EDP電子數(shù)據(jù)處理系統(tǒng)Emerge ncy en velope應(yīng)急信件End point終占八、En dpo int Criteria終點(diǎn)指標(biāo)En dpo int criteria/ measureme nt終點(diǎn)指標(biāo)Equivale nee等效性Esse ntial Docume ntati on必需文件Ethics committee倫理委員會(huì)Excelle nt顯效Ex

15、clusion criteria排除標(biāo)準(zhǔn)Factorial desig n析因設(shè)計(jì)Failure無(wú)效失敗Final point終占八、Fixed-dose procedure固定劑量法Forced titrati on強(qiáng)制滴定Full an alysis set全分析集GC- FTIR氣相色譜-傅利葉紅外聯(lián)用GC- MS氣相色譜-質(zhì)譜聯(lián)用Gen eric drug通用名藥Global assessme nt variable全局評(píng)價(jià)變量GLU血糖Good cli ni cal practice, GCP藥物臨床試驗(yàn)質(zhì)量管理規(guī)范Good manu facture practice, GMP藥品生

16、產(chǎn)質(zhì)量管理規(guī)范Good non-cli ni cal laboratory practice,藥物非臨床研究質(zhì)量管理規(guī)范Group seque ntial desig n成組序貫設(shè)計(jì)Health econo mic evaluati on, HEV健康經(jīng)濟(jì)學(xué)評(píng)價(jià)Hypothesis test假設(shè)檢驗(yàn)Hypothesis test ing假設(shè)檢驗(yàn)Improveme nt好轉(zhuǎn)Inclusion Criteria入選表準(zhǔn)英文全稱(chēng)中文全稱(chēng)Inclusion criteria入選標(biāo)準(zhǔn)In depe ndent ethics committeeIEC獨(dú)立倫理委員會(huì)In formatio n consent

17、 formICF知情同意書(shū)Information Gathering信息收集In formed consent IC知情同意In itial meet ing啟動(dòng)會(huì)議In spect ion檢察/視察In stituti on in spect ion機(jī)構(gòu)檢查In stituti on review board, IBR機(jī)構(gòu)審查委員會(huì)Inten tio n-to treatITT意向性分析（統(tǒng)計(jì)學(xué)）In teractive voice resp onse systemIVRS互動(dòng)式語(yǔ)音應(yīng)答系統(tǒng)In terim an alysis期中分析Intern ati onal Conference of

18、Harmoni zati on人用藥品注冊(cè)技術(shù)要求國(guó)際技術(shù)協(xié)調(diào)會(huì)國(guó)際協(xié)調(diào)會(huì)議In vestigati onal Product試驗(yàn)藥物In vestigator研究者Investigator' s brochure, IB研究者手冊(cè)Last observati on carry forward, LOCF最接近一次觀(guān)祭的結(jié)轉(zhuǎn)LC MS液相色譜-質(zhì)譜聯(lián)用LD50板數(shù)致死劑量LOCF, Last observati on carry forward最近一次觀(guān)祭的結(jié)轉(zhuǎn)Logic check邏輯檢查L(zhǎng)OQ (Limit of Qua ntizati on)定量限Lost of follow u

19、p失訪(fǎng)Marketing approval/ authorization上市許可證Matched pair匹配配對(duì)Miss ing value缺失值Mixed effect model混合效應(yīng)模式Mo nitor監(jiān)察員Mon itori ng監(jiān)杳Mon itori ng Pla n監(jiān)察計(jì)劃M(mǎn)on itori ng Report監(jiān)察報(bào)告MRT平均滯留時(shí)間MS質(zhì)譜MS- MS質(zhì)譜-質(zhì)譜聯(lián)用MTD( Maximum Tolerated Dose )最大耐受劑量Multi-ce nter Trial多中心試驗(yàn)英文全稱(chēng)中文全稱(chēng)New chemical en tity NCE新化學(xué)實(shí)體New drug a

20、pplicationNDA新約甲請(qǐng)NMR核磁共振譜No n-cli nical Study非臨床研究Non-i nferiority非劣效性Non-parametric statistics非參數(shù)統(tǒng)計(jì)方法Obedie nee依從性O(shè)DR旋光光譜Open-label非盲Opti onal titrati on隨意滴定Origi nal medical record原始醫(yī)療記錄Outcome結(jié)果Outcome Assessme nt結(jié)果評(píng)價(jià)Outcome assessme nt結(jié)果指標(biāo)評(píng)價(jià)Outcome measureme nt結(jié)果指標(biāo)Outlier離群值Parallel group desig

21、n平行組設(shè)計(jì)Parameter estimati on參數(shù)估計(jì)Parametric statistics參數(shù)統(tǒng)計(jì)方法Patient file病人檔案Patie nt history病歷Per protocol PP符合方案集Placebo安慰劑Placebo con trol安慰劑對(duì)照Polytomies多分類(lèi)Power檢驗(yàn)效能Precisi on精密度Precli nical study臨床前研究Primary en dpo int主要終點(diǎn)Primary variable主要變量Prin ciple in vestigatorPI主要研究者Product lice nse PL產(chǎn)品許可證Pr

22、otocol試驗(yàn)方案Protocol Ame ndme nts修正案Quality assura nee QA質(zhì)量保證Quality assura nee un it QAU質(zhì)量保證部門(mén)Quality control QC質(zhì)量控制英文全稱(chēng)中文全稱(chēng)Query list query form應(yīng)用疑問(wèn)表Ran domizati on隨機(jī)Range check范圍檢查Rati ng scale量表Refere nee Product參比制劑Regulatory authoritiesRA監(jiān)督管理部門(mén)Replicati on可重復(fù)RSD日內(nèi)和日間相對(duì)標(biāo)準(zhǔn)差Run in準(zhǔn)備期Safety evaluati

23、 on安全性評(píng)價(jià)Safety set安全性評(píng)價(jià)的數(shù)據(jù)集Sample size樣本量樣本大小Scale of ordered categorical rat ings有序分類(lèi)指標(biāo)Secon dary variable次要變量Sequenee試驗(yàn)次序Serious adverse eve nt SAE嚴(yán)重不良事件Serious adverse react ion SAR嚴(yán)重不良反應(yīng)Serious ness嚴(yán)重性Severity嚴(yán)重程度Severity嚴(yán)重程度Signi fica nt level檢驗(yàn)水準(zhǔn)Simple Ran domizati on簡(jiǎn)單隨機(jī)Si ngle bli nding單盲Sit

24、e audit試驗(yàn)機(jī)構(gòu)稽查SOP試驗(yàn)室的標(biāo)準(zhǔn)操作規(guī)程Source data SD原始數(shù)據(jù)Source data verificati on SDV原始數(shù)據(jù)核準(zhǔn)Source docume nt SD原始文件Specificity特異性Sponsor申辦者Sponsor-in vestigator申辦研究者Stan dard curve標(biāo)準(zhǔn)曲線(xiàn)Stan dard operati ng procedureSOP標(biāo)準(zhǔn)操作規(guī)程Statistic統(tǒng)計(jì)量Statistical an alysis pla n統(tǒng)計(jì)分析計(jì)劃Statistical model統(tǒng)計(jì)模型Statistical tables統(tǒng)計(jì)分析表英

25、文全稱(chēng)中文全稱(chēng)Stratified分層Study Audit研究稽查Study audit研究稽查Study Site研究中心Subgroup亞組Sub-i nvestigator助理研究者Subject受試者Subject受試者Subject diary受試者日記Subject En rollme nt受試者入選Subject en rollme nt log受試者入選表Subject ide ntificati on codeSIC受試者識(shí)別代碼Subject Identification Code List受試者識(shí)別代碼表Subject Recruitme nt受試者招募Subject

26、scree ning log受試者師選表Superiority檢驗(yàn)Survival an alysis生存分析SXRD單晶X-射線(xiàn)衍射System audit系統(tǒng)稽查System Audit系統(tǒng)稽查T(mén)1/2消除半衰期Target variable目標(biāo)變量T- BIL總膽紅素T- CHO總膽固醇Test Product受試制劑TG熱重分析TLC HPLC制備色譜Tmax峰時(shí)間TP總蛋白Tran sformatio n變量變換Treatme nt group試驗(yàn)組Trial error試驗(yàn)誤差Trial In itial Meet ing試驗(yàn)啟動(dòng)會(huì)議Trial Master File試驗(yàn)總檔案Tr

27、ial objective試驗(yàn)?zāi)康腡rial site試驗(yàn)場(chǎng)所Triple bli nding二盲英文全稱(chēng)中文全稱(chēng)Two on e-side test雙單側(cè)檢驗(yàn)Un-bli nding揭盲Un expected adverse eventUAE預(yù)料外不良事件UV VIS紫外-可見(jiàn)吸收光譜Variability變異Variable變量Visual an alogy scale直觀(guān)類(lèi)比打分法Visual check人工檢查Vuln erable subject弱勢(shì)受試者Wash-out洗脫Washout period洗脫期實(shí)驗(yàn)室檢查英文縮與英文全稱(chēng)中文全稱(chēng)血常規(guī)WBC white blood ce

28、ll cou nt白細(xì)胞計(jì)數(shù)GR% gran ulocyte中性粒細(xì)胞白分比LY% lymphocyte淋巴細(xì)胞百分比MID%中值細(xì)胞百分比EOS% eosimophil嗜酸性粒細(xì)胞百分比AL% allergy lymphocyte變異淋巴細(xì)胞百分比ST%中性桿狀粒細(xì)胞百分比RBC red blood cell紅細(xì)胞計(jì)數(shù)HGB hemoglobi n血紅蛋白HCT hematocrit 紅細(xì)胞比積紅細(xì)胞比積MCV mean corpusular volume平均紅細(xì)胞體積MCH mea n corpusular hemoglob in平均紅細(xì)胞血紅蛋白含量MCHC mea n corpuscu

29、lar hemoglob in concern trati on平均紅細(xì)胞血紅蛋白濃度RDW red blood cell volume distributi on紅細(xì)胞分布寬度變異PLT/fePC platelet cou nt/blood platelet血小板計(jì)數(shù)MPVtmea n platelet volume平均血小板體積PCT plateletocrit血小板比積PDW platelet distribution width血小板分布寬度尿便常規(guī)PH acidity酸堿度NIT nitrite亞硝酸鹽GLU glucose尿糖SG specific gravity比重PRO pro

30、tein尿蛋白BLD blood隱血BIL bilirubin尿膽紅素URO urobil inogen尿膽原WBC white blood cell白細(xì)胞addish 計(jì)數(shù) addish count艾迪氏計(jì)數(shù)/HP high power objective每高倍視野/LP low power objective每低倍視野OB occult blood test大便隱血試驗(yàn)體液常規(guī)CSF cerebrosp inal腦積夜Pandy pandy龐氏試驗(yàn)英文全稱(chēng)中文全稱(chēng)生化檢驗(yàn)TB total bilirubin總膽紅素DB direct bilirub in直接膽紅素TP total prot

31、ein總蛋白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丙氨酸氨基轉(zhuǎn)移酶AST aspartate aminotran sferase門(mén)冬氨酸氨基轉(zhuǎn)移酶GGT y -glutamyl transpeptadase谷氨酰轉(zhuǎn)肽酶CK creat ine kin ase肌酸肌酶CK-MB creatine kinase-MB肌酸肌酶同工酶LDH lactate dehydroge nase乳酸脫氫酶a -HBD a -hydroxybutyric dehydrogenasea 羥丁酸脫氫酶AMY serum amylase血淀粉酶TG triglyceride肝油三脂CHOL cholesterol膽固醇HDL-c high-de nsity lipoprotein高密度脂蛋白EDLest§W-lde nsity