臨床試驗以及實驗室中常見的中英文名詞及縮寫

1、范文范例指導學習wor皈本整理分享佰榮泰華BioTell Consulting中國創(chuàng)新藥咨詢與服務先鋒CRO臨床試驗以及實驗室中常見的英文縮寫范文范例指導學習藥物臨床試驗英文縮寫縮略語英文全稱中文全稱ADEAdverse Drug Event藥物不良事件ADRAdverse Drug Reaction藥物不良反應AEAdverse Event不良事件AIAssistant Investigator助理研究者BMIBody Mass Index體質(zhì)指數(shù)CICo-investigator合作研究者COICoordinating Investigator協(xié)調(diào)研究者CRCClinical Resear

2、ch Coordinator臨床研究協(xié)調(diào)者CRFCase Report Form病歷報告表CROContract Research Organization合同研究組織CSAClinical Study Application臨床研究申請CTAClinical Trial Application臨床試驗申請CTXClinical Trial Exemption臨床試驗免責CTPClinical Trial Protocol臨床試驗方案CTRClinical Trial Report臨床試驗報告DSMBEDCData Safety and monitoring Board Electronic

3、Data Capture數(shù)據(jù)安全及監(jiān)控委員會 電子數(shù)據(jù)采集系統(tǒng)EDPElectronic Data Processing電子數(shù)據(jù)處理系統(tǒng)FDAFood and Drug Administration美國食品與藥品管理局FRFinal Report總結(jié)報告GCPGood Clinical Practice藥物臨床試驗質(zhì)量管理規(guī)范GCPGood Laboratory Practice藥物非臨床試驗質(zhì)量管理規(guī)范GMPGood Manufacturing Practice藥品生產(chǎn)質(zhì)量管理規(guī)范IBInvestigator ' s Brochure研究者手冊ICInformed Consent知情

4、同意ICFInformed Consent Form知情同意書ICHInternational Conference on國際協(xié)調(diào)會議IDMHdependenioData Monitoring獨立數(shù)據(jù)監(jiān)察IDMCIndependent Data Monitoring獨立數(shù)據(jù)監(jiān)察委員會IECCompmindent Ethics Committee獨立倫理委員會INDInvestigational New Drug新藥臨床研究IRBInstitutional Review Board機構(gòu)審查委員會IVDIn Vitro Diagnostic體外診斷IVRSInteractive Voice Res

5、ponse System互動語音應答系統(tǒng)MAMarketing Approval/Authorization上市許可證MCAMedicines Control Agency英國藥品監(jiān)督局MHWMinistry of Health and Welfare日本衛(wèi)生福利部NDANew Drug Application新藥申請1NECNew Drug Entity新化學實體NIHNational Institutes of Health國家衛(wèi)生研究所（美國）縮略語英文全稱中文全稱PIPrincipal Investigator主要研究者PLProduct License產(chǎn)品許可證PMAPre-mark

6、et Approval (Application)上市前許可（申請）PSIStatisticians in the Pharmaceutical制藥業(yè)統(tǒng)計學家協(xié)會QAQndustyy Assurance質(zhì)量保證QCQuality Control質(zhì)量控制RARegulatory Authorities監(jiān)督管理部門SASite Assessment現(xiàn)場評估SAESerious Adverse Event嚴重不良事件SAPStatistical Analysis Plan統(tǒng)計分析計劃一SARSerious Adverse Reaction嚴重不良反應SDSource Data/Document原始數(shù)

7、據(jù)/文件SDSubject Diary受試者日記SFDAState Food and Drug Administration國家食品藥品監(jiān)督管理局SDVSource Data Verification原始數(shù)據(jù)核準SELSubject Enrollment Log受試后選表SISub-investigator助理研究者SISponsor-Investigator申辦研究者SICSubject Identification Code受試者識別代碼SOPStandard Operating Procedure標準操作規(guī)程SPLStudy Personnel List研究人員名單SSLSubject

8、Screening Log受試者篩選表T&RTest and Reference Product受試和參比試劑UAEUnexpected Adverse Event預料外不良事件WHOWorld Health Organization世界衛(wèi)生組織WHO-ICDRAWHO International Conference ofDrug Regulatory AuthoritiesWHO!際藥品管理當局會議藥物臨床試驗英文縮寫英文全稱中文全稱Accuracy準確度Active control, AC陽性對照活性對照Adverse drug reaction, ADR藥物不良反應Advers

9、e event, AE不良事件Adverse medical events不良醫(yī)學事件Adverse reaction藥物不良反應Alb白蛋白ALD (Approximate Lethal Dose )近似致夕匕劑量ALP堿性磷酸酶Alpha spending function消耗函數(shù)ALT丙氨酸氨基轉(zhuǎn)換酶Analysis sets統(tǒng)計分析的數(shù)據(jù)集Approval批準Assistant investigator助理研究者AST天門冬酸氨基轉(zhuǎn)換酶ATR衰減全反射法AUCss穩(wěn)態(tài)血藥濃度一時間曲線卜面積Audit稽查Audit or inspection稽查/視察Audit report稽查報告A

10、uditor航員Bias偏性偏倚Bioequivalence生物等效應Blank control空白對照Blind codes編制盲底Blind review自態(tài)審核Blind review盲態(tài)檢查Blinding method盲法Blinding/masking盲法/設盲Block層Block size每段的長度Carryover effect延滯效應Case history病歷Case report form/ case record form CRF病例報告表病例記錄表Categorical variable分類及重英文全稱中乂全稱Cav平均濃度CD圓二色譜CL清除率Clinical e

11、quivalence臨床等效應Clinical study臨床研究Clinical study report臨床試驗的總結(jié)報告Clinical trial臨床試驗Clinical trial applicationCTA臨床試驗申請Clinical trial exemptionCTX臨床試驗免責Clinical trial protocol CTP臨床試驗方案Clinical trial/ study report臨床試驗報告Cmax峰濃度Co-investigator合作研究者Comparison對照Compliance依從性Composite variable復合變量Computer-a

12、ssisted trial design CATD計算機輔助試驗設計Confidence interval可信區(qū)間Confidence level置信水平Consistency test一致性檢驗Contract research organization CRO合同研究組織Contract/ agreement協(xié)議/合同Control group對照組Coordinating committee協(xié)調(diào)委員會Crea肌酎CRF(case report form)病例報告表Crossover design交叉設計Cross-over Study交叉研究Css穩(wěn)濃度Cure痊愈Data manage

13、ment數(shù)據(jù)管理Database建立數(shù)據(jù)庫Descriptive statistical analysis描述性統(tǒng)計分析DF波動系統(tǒng)Dichotomies二分類DiviationBitDocumentation記錄/文件英文全稱中乂全稱Dose-reaction relation劑量-反應關系Double dummy雙模擬Double dummy technique雙盲雙模擬技術Drop out脫落DSC差示掃描熱量計Effectiveness療效Electronic data capture EDC電子數(shù)據(jù)采集系統(tǒng)Electronic data processing EDP電子數(shù)據(jù)處理系統(tǒng)E

14、mergency envelope應急信件End point終點Endpoint Criteria終點指標Endpoint criteria/ measurement終點指標Equivalence等效性Essential Documentation必需文件Ethics committee倫理委員會Excellent顯效Exclusion criteria排除標準Factorial design析因設計Failure無效失敗Final point終點Fixed-dose procedure固定劑量法Forced titration強制滴定Full analysis set全分析集GC- FTIR

15、氣相色譜-傅利葉紅外聯(lián)用GC- MS氣相色譜-質(zhì)譜聯(lián)用Generic drug通用名藥Global assessment variable全局評價變量GLU血糖Good clinical practice, GCP藥物臨床試驗質(zhì)量管理規(guī)范Good manufacture practice, GMP藥品生產(chǎn)質(zhì)量管理規(guī)范Good non-clinical laboratory practice,藥物非臨床研究質(zhì)量管理規(guī)范Group sequential design成組序貫設計Health economic evaluation, HEV健康經(jīng)濟學評價Hypothesis test假設檢驗Hypo

16、thesis testing假設檢驗Improvement好轉(zhuǎn)Inclusion Criteria入選表準英文全稱中文全稱Inclusion criteria入選標準Independent ethics committeeIEC獨立倫理委員會Information consent formICF知情同意書Information Gathering信息收集Informed consent IC知情同意Initial meeting啟動會議Inspection檢察/視察Institution inspection機構(gòu)檢查Institution review board, IBR機構(gòu)審查委員會Int

17、ention-to treatITT意向性分析（統(tǒng)計學）Interactive voice response systemIVRS互動式語音應答系統(tǒng)Interim analysis期中分析International Conference ofHarmonization人用藥品注冊技術要求國際技術協(xié)調(diào)會國際協(xié)調(diào)會議Investigational Product試驗藥物Investigator研究者Investigator ' s brochure, IB研究者手冊Last observation carry forward, LOCF最接次觀察的結(jié)轉(zhuǎn)LC MS液相色譜-質(zhì)譜聯(lián)用LD50板

18、數(shù)致夕匕劑量LOCF, Last observation carry forward最次觀察的結(jié)轉(zhuǎn)Logic check邏輯檢查LOQ (Limit of Quantization)定量限Lost of follow up失訪Marketing approval/ authorization上市許可證Matched pair匹配配對Missing value缺失值Mixed effect model混合效應模式Monitor監(jiān)察員Monitoring監(jiān)查Monitoring Plan監(jiān)察計劃Monitoring Report監(jiān)察報告MRT平均滯留時間MS質(zhì)譜MS- MS質(zhì)譜-質(zhì)譜聯(lián)用MTD(

19、Maximum Tolerated Dose )取大耐受劑里Multi-center Trial多中心試驗英文全稱中乂全稱New chemical entity NCE新化學實體New drug applicationNDA新藥申請NMR核磁共振譜Non-clinical Study非臨床研究Non-inferiority非劣效性Non-parametric statistics非參數(shù)統(tǒng)計方法Obedience依從性ODR旋光光譜Open-label非盲Optional titration隨意滴定Original medical record原始醫(yī)療記錄Outcome結(jié)果Outcome Ass

20、essment結(jié)果評價Outcome assessment結(jié)果指標評價Outcome measurement結(jié)果指標Outlier離群值Parallel group design平行組設計Parameter estimation參數(shù)估計Parametric statistics參數(shù)統(tǒng)計方法Patient file病人檔案Patient history病歷Per protocol PP符合方案集Placebo安慰劑Placebo control安慰劑對照Polytomies多分類Power檢驗效能Precision精密度Preclinical study臨床前研究Primary endpoint

21、主要終點Primary variable主要變量Principle investigatorPI主要研究者Product license PL產(chǎn)品許可證Protocol試驗方案Protocol Amendments修正案Quality assurance QA質(zhì)量保證Quality assurance unit QAU質(zhì)量保證部門Quality control QC質(zhì)量控制英文全稱中乂全稱Query list query form應用疑問表Randomization隨機Range check范圍檢查Rating scale里表Reference Product參比制劑Regulatory au

22、thoritiesRA監(jiān)督管理部門Replication可重復RSD日內(nèi)和日間相對標準差Run in準備期Safety evaluation安全性評價Safety set安全性評價的數(shù)據(jù)集Sample size樣本重樣本大小Scale of ordered categorical ratings有序分類指標Secondary variable次要變量Sequence試驗次序Serious adverse event SAE嚴重不良事件Serious adverse reaction SAR嚴重不良反應Seriousness嚴重性Severity嚴重程度Severity嚴重程度Significa

23、nt level檢驗水準Simple Randomization簡單隨機Single blinding單自Site audit試驗機構(gòu)稽查SOP試驗室的標準操作規(guī)程Source data SD原始數(shù)據(jù)Source data verification SDV原始數(shù)據(jù)核準Source document SD原始文件Specificity特異性Sponsor申辦者Sponsor-investigator申辦研究者Standard curve標準曲線Standard operating procedureSOP標準操作規(guī)程Statistic統(tǒng)計量Statistical analysis plan統(tǒng)計分

24、析計劃Statistical model統(tǒng)計模型Statistical tables統(tǒng)計分析表英文全稱中乂全稱Stratified分層Study Audit研究稽查Study audit研究桁食Study Site研究中心Subgroup亞組Sub-investigator助理研究者Subject受試者Subject受試者Subject diary受試者日記Subject Enrollment受試者入選Subject enrollment log受試后入選表Subject identification codeSIC受試者識別代碼Subject Identification Code List

25、受試者識別代碼表Subject Recruitment受試者招募Subject screening log受試者篩選表Superiority檢驗Survival analysis生存分析SXRD單晶X-射線衍射System audit系統(tǒng)稽查System Audit系統(tǒng)稽查T1/2消除半衰期Target variable目標變量TBIL總膽紅素TCHO總膽固醇Test Product受試制劑TG熱重分析TLG HPLC制備色譜Tmax峰時間TP總蛋白Transformation變量變換Treatment group試驗組Trial error試驗誤差Trial Initial Meeting試

26、驗啟動會議Trial Master File試驗總檔案Trial objective試驗目的Trial site試驗場所Triple blinding二盲英文全稱中文全稱Two one-side test雙單側(cè)檢驗Un-blinding揭盲Unexpected adverse eventUAE預料外不良事件UW VIS紫外-可見吸收光譜Variability變異Variable變量Visual analogy scale直觀類比打分法Visual check人工檢查Vulnerable subject弱勢受試者Wash-out洗脫Washout period洗脫期實驗室檢查英文縮寫英文全稱中文

27、全稱血常規(guī)WBC white blood cell count白細胞計數(shù)GR% granulocyte中性粒細胞百分比LY% lymphocyte淋巴細胞百分比MID%中值細胞百分比EOS% eosimophil嗜酸性粒細胞百分比AL% allergy lymphocyte變異淋巴細胞百分比ST%中性桿狀粒細胞百分比RBC red blood cell紅細胞計數(shù)HGB hemoglobin血紅蛋白HCT hematocrit 紅細胞比積紅細胞比積MCV mean corpusular volume平均紅細胞體積MCH mean corpusular hemoglobin平均紅細胞血紅蛋白含量M

28、CHC mean corpuscular hemoglobin concerntration平均紅細胞血紅蛋白濃度RDW red blood cell volume distribution紅細胞分布寬度變異wLThBPC platelet count/blood platelet血小板計數(shù)MPVtmean 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 gravit

29、y比重PRO protein尿蛋白BLD blood隱血BIL bilirubin尿膽紅素URO urobilinogen尿膽原WBC white blood cell白細胞addish 計數(shù) addish count艾迪氏計數(shù)/HP high power objective每高倍視野/LP low power objective每低倍視野OB occult blood test大便隱血試驗體液常規(guī)CSF cerebrospinal腦積夜Pandy pandy龐氏試驗英文全稱中文全稱生化檢驗TB total bilirubin總膽紅素DB direct bilirubin直接膽紅素TP tot

30、al protein總蛋白ALB 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丙氨酸氨基轉(zhuǎn)移酶AST aspartate aminotransferase口冬氨酸氨基轉(zhuǎn)移酶GGT 丫 -glutamyl transpeptadase谷氨酰轉(zhuǎn)肽酶CK creatine kinase肌酸肌酶CK-MB creatine kinase-MB肌酸肌酶同工酶LDH lactate dehydrogenase乳酸脫氫酶a -HBD a -hydroxybutyric dehydrogenase“-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-density lipoprotein高密度脂蛋白LDLesteW-density lipopr