1、藥物臨床試驗(yàn)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(yīng)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 Research Coordinator臨床研究協(xié)調(diào)者CRFCase Report Form病歷報(bào)告表CROContract Research Organization合

2、同研究組織CSAClinical Study Application臨床研究申請CTAClinical Trial Application臨床試驗(yàn)申請CTXClinical Trial Exemption臨床試驗(yàn)免責(zé)CTPClinical Trial Protocol臨床試驗(yàn)方案CTRClinical Trial Report臨床試驗(yàn)報(bào)告DSMBData Safety and monitoring Board數(shù)據(jù)安全及監(jiān)控委員會(huì)EDCElectronic Data Capture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 D

3、rug Administration美國食品與藥品管理局FRFinal Report總結(jié)報(bào)告GCPGood Clinical 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)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知情同意ICFInformed Consent Form知情同意書ICHInternational Conference on Harmonization國際協(xié)調(diào)會(huì)議IDMInd

4、ependent Data Monitoring獨(dú)立數(shù)據(jù)監(jiān)察IDMCIndependent Data Monitoring Committee獨(dú)立數(shù)據(jù)監(jiān)察委員會(huì)IECIndependent Ethics Committee獨(dú)立倫理委員會(huì)INDInvestigational New Drug新藥臨床研究IRBInstitutional Review Board機(jī)構(gòu)審查委員會(huì)IVDIn Vitro Diagnostic體外診斷IVRSInteractive V oice Response System互動(dòng)語音應(yīng)答系統(tǒng)MAMarketing Approval/Authorization上市許可證MC

5、AMedicines 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NECNew Drug Entity新化學(xué)實(shí)體NIHNational Institutes of Health國家衛(wèi)生研究所（美國）PIPrincipal Investigator主要研究者PLProduct License產(chǎn)品許可證1縮略語英文全稱中文全稱PMAPre-market Approval (Application)上市前許可（申請）PSIStatisticians in the Pha

6、rmaceutical Industry制藥業(yè)統(tǒng)計(jì)學(xué)家協(xié)會(huì)QAQuality 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(yán)重不良事件SAPStatistical Analysis Plan統(tǒng)計(jì)分析計(jì)劃SARSerious Adverse Reaction嚴(yán)重不良反應(yīng)SDSource Data/Document原始數(shù)據(jù) /文件SDSubject Diary受試者日記SFDAState Food and Drug Admin

7、istration國家食品藥品監(jiān)督管理局SDVSource Data Verification原始數(shù)據(jù)核準(zhǔn)SELSubject Enrollment Log受試者入選表SISub-investigator助理研究者SISponsor-Investigator申辦研究者SICSubject Identification Code受試者識(shí)別代碼SOPStandard Operating Procedure標(biāo)準(zhǔn)操作規(guī)程SPLStudy Personnel List研究人員名單SSLSubject Screening Log受試者篩選表T&RTest and Reference Product受試和參

8、比試劑UAEUnexpected Adverse Event預(yù)料外不良事件WHOWorld Health Organization世界衛(wèi)生組織WHO-ICDRAWHO International Conference ofWHO 國際藥品管理當(dāng)局會(huì)議Drug Regulatory Authorities藥物臨床試驗(yàn)英文縮寫英文全稱中文全稱Accuracy準(zhǔn)確度Active control, AC陽性對照活性對照Adverse drug reaction, 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 reac

9、tion藥物不良反應(yīng)Alb白蛋白ALD （ Approximate Lethal Dose ）近似致死劑量2英文全稱中文全稱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(jì)分析的數(shù)據(jù)集Approval批準(zhǔn)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)血藥濃度時(shí)間曲線下面積Audit稽查Audit or inspection稽查視察Audit report稽查報(bào)告Auditor稽查員Bias偏性 偏倚Bioequivalence生物等效應(yīng)Blank contr

10、ol空白對照Blind codes編制盲底Blind review盲態(tài)審核Blind review盲態(tài)檢查Blinding method盲法Blinding/masking盲法 /設(shè)盲Block層Block size每段的長度Carryover effect延滯效應(yīng)Case history病歷Case report form/ case record form CRF病例報(bào)告表病例記錄表Categorical variable分類變量Cav平均濃度CD圓二色譜CL清除率Clinical equivalence臨床等效應(yīng)Clinical study臨床研究Clinical study repor

11、t臨床試驗(yàn)的總結(jié)報(bào)告Clinical trial臨床試驗(yàn)Clinical trial applicationCTA臨床試驗(yàn)申請Clinical trial exemptionCTX臨床試驗(yàn)免責(zé)Clinical trial protocol CTP臨床試驗(yàn)方案Clinical trial/ study report臨床試驗(yàn)報(bào)告Cmax峰濃度Co-investigator合作研究者3英文全稱中文全稱Comparison對照Compliance依從性Composite variable復(fù)合變量Computer-assisted trial design CATD計(jì)算機(jī)輔助試驗(yàn)設(shè)計(jì)Confidence

12、 interval可信區(qū)間Confidence level置信水平Consistency test一致性檢驗(yàn)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(huì)Crea肌酐CRF(case report form)病例報(bào)告表Crossover design交叉設(shè)計(jì)Cross-over Study交叉研究Css穩(wěn)濃度Cure痊愈Data management數(shù)據(jù)管理Database建立數(shù)據(jù)庫Descriptive statistical

13、analysis描述性統(tǒng)計(jì)分析DF波動(dòng)系統(tǒng)Dichotomies二分類Diviation偏差Documentation記錄文件Dose-reaction relation劑量反應(yīng)關(guān)系Double dummy雙模擬Double dummy technique雙盲雙模擬技術(shù)Drop out脫落DSC差示掃描熱量計(jì)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)Emergency envelope應(yīng)急信件End point終點(diǎn)Endpoint Criteria終點(diǎn)指標(biāo)End

14、point criteria/ measurement終點(diǎn)指標(biāo)Equivalence等效性Essential Documentation必需文件Ethics committee倫理委員會(huì)Excellent顯效4英文全稱中文全稱Exclusion criteria排除標(biāo)準(zhǔn)Factorial design析因設(shè)計(jì)Failure無效 失敗Final point終點(diǎn)Fixed-dose procedure固定劑量法Forced titration強(qiáng)制滴定Full analysis 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Generic drug通用名藥Global

15、assessment variable全局評價(jià)變量GLU血糖Good clinical practice, GCP藥物臨床試驗(yàn)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, GLP藥物非臨床研究質(zhì)量管理規(guī)范Group sequential design成組序貫設(shè)計(jì)Health economic evaluation, HEV健康經(jīng)濟(jì)學(xué)評價(jià)Hypothesis test假設(shè)檢驗(yàn)Hypothesis testing假設(shè)檢驗(yàn)Improvement好轉(zhuǎn)Inclusion Crite

16、ria入選表準(zhǔn)Inclusion criteria入選標(biāo)準(zhǔn)Independent ethics committeeIEC獨(dú)立倫理委員會(huì)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(dòng)會(huì)議Inspection檢察 /視察Institution inspection機(jī)構(gòu)檢查Institution review board, IBR機(jī)構(gòu)審查委員會(huì)Intention-totreat ITT意向性分析 ( 統(tǒng)計(jì)學(xué)）Interactive voice respo

17、nse system IVRS互動(dòng)式語音應(yīng)答系統(tǒng)Interim analysis期中分析InternationalConferenceofHarmonization人用藥品注冊技術(shù)要求國際技術(shù)協(xié)調(diào)會(huì)國ICH際協(xié)調(diào)會(huì)議Investigational Product試驗(yàn)藥物Investigator研究者Investigator s brochure, IB研究者手冊Last observation carry forward, LOCF最接近一次觀察的結(jié)轉(zhuǎn)LC MS液相色譜質(zhì)譜聯(lián)用5英文全稱中文全稱LD50板數(shù)致死劑量LOCF, Last observation carry forward最近一次

18、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(yīng)模式Monitor監(jiān)察員Monitoring監(jiān)查Monitoring Plan監(jiān)察計(jì)劃Monitoring Report監(jiān)察報(bào)告MRT平均滯留時(shí)間MS質(zhì)譜MSMS質(zhì)譜質(zhì)譜聯(lián)用MTD （Maximum Tolerated Dose ）最大耐受劑量Multi-center Tria

19、l多中心試驗(yàn)New chemical entityNCE新化學(xué)實(shí)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(jì)方法Obedience依從性O(shè)DR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 Assessment結(jié)果評價(jià)Outcome assessment結(jié)果指標(biāo)評價(jià)Outcome measurement結(jié)果

20、指標(biāo)Outlier離群值Parallel group design平行組設(shè)計(jì)Parameter estimation參數(shù)估計(jì)Parametric statistics參數(shù)統(tǒng)計(jì)方法Patient file病人檔案Patient history病歷Per protocol PP符合方案集6英文全稱中文全稱Placebo安慰劑Placebo control安慰劑對照Polytomies多分類Power檢驗(yàn)效能Precision精密度Preclinical study臨床前研究Primary endpoint主要終點(diǎn)Primary variable主要變量Principle investigatorP

21、I主要研究者Product license PL產(chǎn)品許可證Protocol試驗(yàn)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Query listquery form應(yīng)用疑問表Randomization隨機(jī)Range check范圍檢查Rating scale量表Reference Product參比制劑Regulatory authoritiesRA監(jiān)督管理部門Replication可重復(fù)RSD日內(nèi)和日間相對標(biāo)準(zhǔn)差Run in準(zhǔn)備期Saf

22、ety evaluation安全性評價(jià)Safety set安全性評價(jià)的數(shù)據(jù)集Sample size樣本量樣本大小Scale of ordered categorical ratings有序分類指標(biāo)Secondary variable次要變量Sequence試驗(yàn)次序Serious adverse event SAE嚴(yán)重不良事件Serious adverse reaction SAR嚴(yán)重不良反應(yīng)Seriousness嚴(yán)重性Severity嚴(yán)重程度Severity嚴(yán)重程度Significant level檢驗(yàn)水準(zhǔn)Simple Randomization簡單隨機(jī)Single blinding單盲Sit

23、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7英文全稱中文全稱Source data SD原始數(shù)據(jù)Source data verification SDV原始數(shù)據(jù)核準(zhǔn)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(biāo)準(zhǔn)曲線Standard operating procedureSOP標(biāo)準(zhǔn)操作規(guī)程Statistic統(tǒng)計(jì)量Statistical analysis plan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

24、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-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受試者入選表Subject identification codeSIC受試者識(shí)別代碼Subject Identification Code List受試者識(shí)別代碼表Subject Recruitment受試者招募Subject screening log受試

25、者篩選表Superiority檢驗(yàn)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(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8英文全稱中文全稱TP總蛋白Transformation變量變換Treatment group試驗(yàn)組Trial error試驗(yàn)誤差Trial Initial Meeting試驗(yàn)啟動(dòng)會(huì)議Trial Master File試驗(yàn)總檔案Trial objectiv

26、e試驗(yàn)?zāi)康腡rial site試驗(yàn)場所Triple blinding三盲Two one-side test雙單側(cè)檢驗(yàn)Un-blinding揭盲Unexpected adverse eventUAE預(yù)料外不良事件UV 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(shí)驗(yàn)室檢查英文縮寫英文全稱中文全稱血常規(guī)WBC white blood cell count白細(xì)胞計(jì)數(shù)GR% granulocyt

27、e中性粒細(xì)胞百分比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 hemoglobin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 mean corpusular hemoglobin平均紅細(xì)胞血紅蛋白含量9英文全稱中文全稱MCHCmeancorpusularhemoglobin平均紅細(xì)胞血紅蛋白濃度conc

28、erntrationRDW red blood cell volume distribution width紅細(xì)胞分布寬度變異PLT/BPC platelet count/blood platelet count血小板計(jì)數(shù)MPV mean 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 protein尿蛋白BLD blood隱血BIL bil

29、irubin尿膽紅素URO urobilinogen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 cerebrospinal腦積夜Pandy pandy龐氏試驗(yàn)生化檢驗(yàn)TB total bilirubin總膽紅素DB direct bilirubin直接膽紅素TP total protein總蛋白ALB albumin白蛋白GLOB globulin球蛋白

30、UREA urea尿素CREA 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門冬氨酸氨基轉(zhuǎn)移酶GGT -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-HBD -hydroxybutyric dehydrogenase羥丁酸脫氫酶10英文全稱AMY seru

31、m amylaseTG triglycerideCHOL cholesterolHDL-c high-density lipoprotein cholesterolLDL-c low-density lipoprotein cholesterolVLDL very low-density lipoproteinCa serum calciumMg serum magnesiumIP inorganic phosphateALP alkaline phosphataseTBA total biliary acidASO antistreptolysina-AG a acid glycoprote

32、inCRP C-reactive protein CRF rheumatoid factorMTP mili-total proteinIgG immunoglobin GIgA immunoglobin AIgM immunoglobin MC3 complement C3C4 complement C4cTNT troponin TMYOG myoglobin電解質(zhì)Na sodiumkalium Cl chloride Ga calciumMg magnesium乙肝標(biāo)志物HBV hepatitis B virusHBsAg hepatitis B surface antigenHBsAb

33、 antibody to hepatitis surface antigen HBcAg hepatitis B core antigenHBcAb antibody to hepatitis B core antigen HBeAg hepatitis B e-antigenHBeAb antibody to hepatitis B e-antigenELISA enzymelinked immunosorbentassyHAV hepatitis A virusHCV hepatitis C virus輸血免疫全套中文全稱血淀粉酶肝油三脂膽固醇高密度脂蛋白低密度脂蛋白極低密度脂蛋白鈣鎂無機(jī)

34、磷堿性磷酸酶總膽汁酸抗鏈球菌溶血素Oa酸性糖蛋白反應(yīng)蛋白類風(fēng)濕因子微量蛋白免疫球蛋白G免疫球蛋白A免疫球蛋白M補(bǔ)體 C3補(bǔ)體 C4肌鈣蛋白 T肌紅蛋白鈉鉀氯鈣鎂乙肝病毒乙肝表面抗原乙肝表面抗體乙肝核心抗原乙肝核心抗體乙肝 e 抗原乙肝 e 抗體酶聯(lián)免疫吸附試驗(yàn)甲肝病毒丙肝病毒11英文全稱中文全稱HBV hepatitis B virus乙型肝炎病毒HCV hepatitis C virus丙型肝炎病毒TP treponema pallidum梅毒螺旋體HIV human immunodeficiency virus人類免疫缺陷病毒Accuracy 準(zhǔn)確度Active control ， AC

35、陽性對照，活性對照Adverse drug reaction， 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 reaction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 spending function消耗函數(shù)ALT 丙氨酸氨基轉(zhuǎn)換酶Analysis sets 統(tǒng)計(jì)分析的數(shù)據(jù)集Approval 批準(zhǔn)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

36、度時(shí)間曲線下面積Audit 稽查12Audit or inspection稽查視察Audit report稽查報(bào)告Auditor稽查員Bias 偏性，偏倚Bioequivalence生物等效應(yīng)Blank control空白對照Blind codes 編制盲底Blind review盲態(tài)審核Blind review盲態(tài)檢查Blinding method盲法Blinding/ masking盲法，設(shè)盲Block 分段Block 層Block size 每段的長度BUN 尿素氮Carryover effect延滯效應(yīng)Case history 病歷Case report form病例報(bào)告表Case r

37、eport form/ case record form， CRF 病例報(bào)告表，病例記錄表Categorical variable分類變量Cav 平均濃度13CD 圓二色譜CL 清除率Clinical equivalence臨床等效應(yīng)Clinical study臨床研究Clinical study report臨床試驗(yàn)的總結(jié)報(bào)告Clinical trial臨床試驗(yàn)Clinical trial application， CTA 臨床試驗(yàn)申請Clinical trial exemption， CTX 臨床試驗(yàn)免責(zé)Clinical trial protocol， CTP 臨床試驗(yàn)方案Clinical

38、 trial/ study report臨床試驗(yàn)報(bào)告Cmax 峰濃度Co-investigator合作研究者Comparison 對照Compliance 依從性Composite variable復(fù)合變量Computer-assisted trial design， CATD 計(jì)算機(jī)輔助試驗(yàn)設(shè)計(jì)Confidence interval可信區(qū)間Confidence level 置信水平Consistency test 一致性檢驗(yàn)Contract research organization， CRO 合同研究組織Contract/ agreement協(xié)議合同14Control group對照組Co

39、ordinating committee協(xié)調(diào)委員會(huì)Crea 肌酐CRF（ case report form ） 病例報(bào)告表Crossover design 交叉設(shè)計(jì)Cross-over study交叉研究Css 穩(wěn)濃度Cure 痊愈Data management 數(shù)據(jù)管理Database 建立數(shù)據(jù)庫Descriptive statistical analysis描述性統(tǒng)計(jì)分析DF 波動(dòng)系統(tǒng)Dichotomies二分類Diviation偏差Documentation記錄文件Dose-reaction relation劑量反應(yīng)關(guān)系Double blinding雙盲Double dummy雙模擬Do

40、uble dummy technique雙盲雙模擬技術(shù)Double-blinding雙盲Drop out 脫落15DSC 差示掃描熱量計(jì)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)Emergency envelope應(yīng)急信件End point 終點(diǎn)Endpoint criteria/ measurement終點(diǎn)指標(biāo)Equivalence 等效性Essential documentation必須文件Ethics committee倫理委員會(huì)Excellen

41、t 顯效Exclusion criteria排除標(biāo)準(zhǔn)Factorial design析因設(shè)計(jì)Failure 無效，失敗Final point終點(diǎn)Fixed-dose procedure固定劑量法Forced titration強(qiáng)制滴定Full analysis 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Generic drug 通用名藥16Global assessment variable全局評價(jià)變量GLU 血糖Good clinical practice， GCP 藥物臨床試驗(yàn)質(zhì)量管理規(guī)范Good manufacture practice， GMP

42、藥品生產(chǎn)質(zhì)量管理規(guī)范Good non-clinical laboratory practice， GLP 藥物非臨床研究質(zhì)量管理規(guī)范Group sequential design成組序貫設(shè)計(jì)Health economic evaluation， HEV 健康經(jīng)濟(jì)學(xué)評價(jià)Hypothesis test假設(shè)檢驗(yàn)Hypothesis testing假設(shè)檢驗(yàn)International Conference of Harmonization， ICH 人用藥品注冊技術(shù)要求國際技術(shù)協(xié)調(diào)會(huì)，國際協(xié)調(diào)會(huì)議Improvement好轉(zhuǎn)Inclusion criteria入選標(biāo)準(zhǔn)Independent ethics

43、committee， IEC 獨(dú)立倫理委員會(huì)Information consent form， ICF 知情同意書Information gathering信息收集Informed consent， IC 知情同意Initial meeting啟動(dòng)會(huì)議Inspection視察檢查Institution inspection機(jī)構(gòu)檢查Institution review board， IBR 機(jī)構(gòu)審查委員會(huì)17Intention to treat意向治療（臨床領(lǐng)域）Intention-to treat ， ITT 意向性分析（統(tǒng)計(jì)學(xué)）Interactive voice response syste

44、m， IVRS 互動(dòng)式語音應(yīng)答系統(tǒng)Interim analysis期中分析Investigator研究者Investigators brochure， IB 研究者手冊IR 紅外吸收光譜Ka 吸收速率常Last observation carry forward， LOCF 最接近一次觀察的結(jié)轉(zhuǎn)LC MS 液相色譜質(zhì)譜聯(lián)用LD50 板數(shù)致死劑量Logic check 邏輯檢查LOQ （ Limit of Quantitation） 定量限LOCF， Last observation carry forward最近一次觀察的結(jié)轉(zhuǎn)Lost of follow up失訪Marketing appro

45、val/ authorization上市許可證Matched pair匹配配對Missing value 缺失值Mixed effect model混合效應(yīng)模式Monitor監(jiān)查員Monitoring監(jiān)查18Monitoring report監(jiān)查報(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Multicenter trial多中心試驗(yàn)Multi-center trial多中心試驗(yàn)New chemical entity， NCE 新化學(xué)實(shí)體New drug application， NDA 新藥申請NMR 核磁共

46、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(jì)方法Obedience依從性O(shè)DR 旋光光譜Open-blinding非盲Open-label非盲Optional titration隨意滴定Original medical record原始醫(yī)療記錄Outcome結(jié)果19Outcome assessment結(jié)果指標(biāo)評價(jià)Outcome measurement結(jié)果指標(biāo)Outlier離群值Parallel group design平行組設(shè)計(jì)Parameter estimation參數(shù)估計(jì)Parametr

47、ic statistics參數(shù)統(tǒng)計(jì)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(yàn)效能Precision精密度Preclinical study臨床前研究Primary endpoint主要終點(diǎn)Primary variable主要變量Principal investigator主要研究者Principle investigator，PI主要研究者Product license，PL產(chǎn)品許可證Protocol試驗(yàn)方案20Protocol

48、試驗(yàn)方案Protocol amendment方案補(bǔ)正Quality assurance unit，QAU 質(zhì)量保證部門Quality assurance，QA質(zhì)量保證Quality control，QC質(zhì)量控制Query list，query form應(yīng)用疑問表Randomization隨機(jī)化Randomization隨機(jī)Range check范圍檢查Rating scale量表Regulatory authorities，RA監(jiān)督管理部門Replication可重復(fù)RSD 日內(nèi)和日間相對標(biāo)準(zhǔn)差Run in準(zhǔn)備期Safety evaluation安全性評價(jià)Safety set安全性評價(jià)的數(shù)據(jù)集

49、Sample size樣本含量Sample size樣本量，樣本大小Scale of ordered categorical ratings有序分類指標(biāo)Secondary variable次要變量Sequence試驗(yàn)次序21Serious adverse event，SAE嚴(yán)重不良事件Serious adverse reaction，SAR 嚴(yán)重不良反應(yīng)Seriousness嚴(yán)重性Severity嚴(yán)重程度Significant level檢驗(yàn)水準(zhǔn)Simple randomization簡單隨機(jī)Single blinding單盲Single-blinding單盲Site audit試驗(yàn)機(jī)構(gòu)稽查S

50、OP 試驗(yàn)室的標(biāo)準(zhǔn)操作規(guī)程Source data verification，SDV 原始數(shù)據(jù)核準(zhǔn)Source data，SD原始數(shù)據(jù)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(biāo)準(zhǔn)曲線Standard operating procedure，SOP 標(biāo)準(zhǔn)操作規(guī)程Statistic統(tǒng)計(jì)量Statistical analysis plan統(tǒng)計(jì)分析計(jì)劃Statistical analysis plan統(tǒng)計(jì)參數(shù)計(jì)劃書22Statistical analysis plan，SA

51、P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Stratified分層Study audit研究稽查Subgroup亞組Sub-investigator助理研究者Subject受試者Subject diary受試者日記Subject enrollment受試者入選Subject enrollment log受試者入選表Subject identification code，SIC受試者識(shí)別代碼Subject recruitment受試者招募Subject screening log受試者篩選表Superiority檢驗(yàn)Survival a

52、nalysis生存分析SXRD 單晶 X射線衍射System audit系統(tǒng)稽查T1/2消除半衰期Target variable目標(biāo)變量T BIL總膽紅素23T CHO 總膽固醇TG熱重分析TLC、 HPLC 制備色譜Tmax峰時(shí)間TP總蛋白Transformation變量變換Treatment group試驗(yàn)組Trial error試驗(yàn)誤差Trial master file試驗(yàn)總檔案Trial objective試驗(yàn)?zāi)康腡rial site試驗(yàn)場所Triple blinding三盲Two one-side test雙單側(cè)檢驗(yàn)Unblinding揭盲Unblinding破盲Unexpected

53、 adverse event，UAE 預(yù)料外不良事件UV 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24Vulnerable subject弱勢受試者Wash-out清洗期Washout period洗脫期Well-being福利，健康1臨床試驗(yàn)（Clinical Trial ）：指任何在人體（病人或健康志愿者身上）進(jìn)行藥品的系統(tǒng)性研究， 以證實(shí)或揭示研究藥品的作用、不良反應(yīng)及或試驗(yàn)用藥品的吸收、分布、 代謝和排泄，目的是確定研究藥品的療效與安全性。2 試驗(yàn)方案（Protoco1 ）：敘述試驗(yàn)的背景、理論基礎(chǔ)和目的，試驗(yàn)設(shè)計(jì)、方法和組織，包括統(tǒng)計(jì)學(xué)考慮、試驗(yàn)執(zhí)行和完成的條件。方案必須由參加試驗(yàn)的主要研究者、研究機(jī)構(gòu)和申辦者簽章并注明日期。3.研究者手冊（ Investigators Brochure ）：是有關(guān)試驗(yàn)用藥品在進(jìn)行