臨床試驗常用中英文詞匯

1、SFDAGlossary:GCP,GLP,TRIALAccuracy準(zhǔn)確度Activecontrol,AC陽性對照，活性對照Adversedrugreaction,ADR藥物不良反應(yīng)Adverseevent,AE不良事件Adversemedicalevents不良醫(yī)學(xué)事件Adversereaction藥物不良反應(yīng)Alb白蛋白ALD(ApproximateLethalDose)近似致死劑量ALP堿性磷酸酶Alphaspendingfunction消耗函數(shù)ALT丙氨酸氨基轉(zhuǎn)換酶Analysissets統(tǒng)計分析的數(shù)據(jù)集Approval批準(zhǔn)Assistantinvestigator助理研究者AST天門

2、冬酸氨基轉(zhuǎn)換酶ATR衰減全反射法AUCss穩(wěn)態(tài)血藥濃度時間曲線下面積Audit稽查Auditorinspection稽查/視察Auditreport稽查報告Auditor稽查員Bias偏性，偏倚Bioequivalence生物等效應(yīng)Blankcontrol空白對照Blindcodes編制盲底Blindreview盲態(tài)審核Blindreview盲態(tài)檢查Blindingmethod盲法Blinding/masking盲法，設(shè)盲Block分段Block層Blocksize每段的長度BUN尿素氮Carryovereffect延滯效應(yīng)Casehistory病歷Casereportform病例報告表Cas

3、ereportform/caserecordform,CRF病例報告表，病例記錄表Categoricalvariable分類變量Cav平均濃度CD圓二色譜CL清除率Clinicalequivalence臨床等效應(yīng)Clinicalstudy臨床研究Clinicalstudyreport臨床試驗的總結(jié)報告Clinicaltrial臨床試驗Clinicaltrialapplication,CTA臨床試驗申請Clinicaltrialexemption,CTX臨床試驗免責(zé)Clinicaltrialprotocol,CTP臨床試驗方案Clinicaltrial/studyreport臨床試驗報告Cmax

4、峰濃度Co-investigator合作研究者Comparison對照Compliance依從性Compositevariable復(fù)合變量Computer-assistedtrialdesign,CATD計算機(jī)輔助試驗設(shè)計Confidenceinterval可信區(qū)間Confidencelevel置信水平Consistencytest一致性檢驗Contractresearchorganization,CRO合同研究組織Contract/agreement協(xié)議/合同Controlgroup對照組Coordinatingcommittee協(xié)調(diào)委員會Crea肌酉千CRF(casereportform)

5、病例報告表Crossoverdesign交叉設(shè)計Cross-overstudy交叉研究Css穩(wěn)濃度Cure痊愈Datamanagement數(shù)據(jù)管理Database建立數(shù)據(jù)庫Descriptivestatisticalanalysis描述性統(tǒng)計分析DF波動系統(tǒng)Dichotomies二分類Diviation偏差Documentationt己錄/文件Dose-reactionrelation齊U量一反應(yīng)關(guān)系Doubleblinding雙盲Doubledummy雙模擬Doubledummytechnique雙盲雙模擬技術(shù)Double-blinding雙盲Dropout脫落DSC差示掃描熱量計Effec

6、tiveness療效Electronicdatacapture,EDC電子數(shù)據(jù)采集系統(tǒng)Electronicdataprocessing,EDP電子數(shù)據(jù)處理系統(tǒng)Emergencyenvelope應(yīng)急信件Endpoint終點Endpointcriteria/measurement終點指標(biāo)Equivalence等效性Essentialdocumentation必須文件Ethicscommittee倫理委員會Excellent顯效Exclusioncriteria排除標(biāo)準(zhǔn)Factorialdesign析因設(shè)計Failure無效，失敗Finalpoint終點Fixed-doseprocedure固定齊U

7、量法Forcedtitration強制滴定Fullanalysisset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Genericdrug通用名藥Globalassessmentvariable全局評價變量GLU血糖Goodclinicalpractice,GCP藥物臨床試驗質(zhì)量管理規(guī)范Goodmanufacturepractice,GMP藥品生產(chǎn)質(zhì)量管理規(guī)范Goodnon-clinicallaboratorypractice,GLP藥物非臨床研究質(zhì)量管理規(guī)范Groupsequentialdesign成組序貫設(shè)計Healtheconomicevaluation,HEV

8、健康經(jīng)濟(jì)學(xué)評價Hypothesistest假設(shè)檢驗Hypothesistesting假設(shè)檢驗InternationalConferenceofHarmonization,ICH人用藥品注冊技術(shù)要求國際技術(shù)協(xié)調(diào)會，國際協(xié)調(diào)會議Improvement好轉(zhuǎn)Inclusioncriteria入選標(biāo)準(zhǔn)Independentethicscommittee,IEC獨立倫理委員會Informationconsentform,ICF知情同意書Informationgathering信息收集Informedconsent,IC知情同意Initialmeeting啟動會議Inspection視察/檢查Institu

9、tioninspection機(jī)構(gòu)檢查Institutionreviewboard,IBR機(jī)構(gòu)審查委員會Intentiontotreat意向治療（臨床領(lǐng)域）Intention-to-treat,ITT意向性分析（一統(tǒng)計學(xué)）Interactivevoiceresponsesystem,IVRS互動式語音應(yīng)答系統(tǒng)Interimanalysis期中分析Investigator研究者Investigatorsbrochure,IB研究者手冊IR紅外吸收光譜Ka吸收速率常Lastobservationcarryforward,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Log

10、iccheck邏輯檢查LOQ(LimitofQuantitation)定量限LOCF,Lastobservationcarryforward最近一次觀察的結(jié)轉(zhuǎn)Lostoffollowup失訪Marketingapproval/authorization上市許可證Matchedpair匹配配對Missingvalue缺失值Mixedeffectmodel混合效應(yīng)模式Monitor監(jiān)查員Monitoring監(jiān)查Monitoringreport監(jiān)查報告MRT平均滯留時間MS質(zhì)譜MS-MS質(zhì)譜質(zhì)譜聯(lián)用MTD(MaximumToleratedDose)最大耐受劑量Multicentertrial多中心試

11、驗Multi-centertrial多中心試驗Newchemicalentity,NCE新化學(xué)實體Newdrugapplication,NDA新藥申請NMR核磁共振譜Non-clinicalstudy非臨床研究Non-inferiority非劣效性Non-parametricstatistics非參數(shù)統(tǒng)計方法Obedience依從性O(shè)DR旋光光譜Open-blinding非盲Open-label非盲Optionaltitration隨意滴定Originalmedicalrecord原始醫(yī)療記錄Outcome結(jié)果Outcomeassessment結(jié)果指標(biāo)評價Outcomemeasurement結(jié)

12、果指標(biāo)Outlier離群值Parallelgroupdesign平行組設(shè)計Parameterestimation參數(shù)估計Parametricstatistics參數(shù)統(tǒng)計方法Patientfile病人檔案Patienthistory病歷Perprotocol,PP符合方案集Placebo安慰劑Placebocontrol安慰劑對照Polytomies多分類Power檢驗效能Precision精密度Preclinicalstudy臨床前研究Primaryendpoint主要終點Primaryvariable主要變量Principalinvestigator主要研究者Principleinvesti

13、gator,PI主要研究者Productlicense,PL產(chǎn)品許可證Protocol試驗方案Protocol試驗方案Protocolamendment方案補正Qualityassuranceunit,QAU質(zhì)量保證部門Qualityassurance,QA質(zhì)量保證Qualitycontrol,QC質(zhì)量控制Querylist,queryform應(yīng)用疑問表Randomization隨機(jī)化Randomization隨機(jī)Rangecheck范圍檢查Ratingscale量表Regulatoryauthorities,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Runin準(zhǔn)備

14、期Safetyevaluation安全性評價Safetyset安全性評價的數(shù)據(jù)集Samplesize樣本含量Samplesize樣本量，樣本大小Scaleoforderedcategoricalratings有序分類指標(biāo)Secondaryvariable次要變量Sequence試驗次序Seriousadverseevent,SAE嚴(yán)重不良事件Seriousadversereaction,SAR嚴(yán)重不良反應(yīng)Seriousness嚴(yán)重性Severity嚴(yán)重程度Significantlevel檢驗水準(zhǔn)Simplerandomization簡單隨機(jī)Singleblinding單盲Single-blin

15、ding單盲Siteaudit試驗機(jī)構(gòu)稽查SOP試驗室的標(biāo)準(zhǔn)操作規(guī)程Sourcedataverification,SDV原始數(shù)據(jù)核準(zhǔn)Sourcedata,SD原始數(shù)據(jù)Sourcedocument,SD原始文件Specificity特異性Sponsor申辦者Sponsor-investigator申辦研究者Standardcurve標(biāo)準(zhǔn)曲線Standardoperatingprocedure,SOP標(biāo)準(zhǔn)操作規(guī)程Statistic統(tǒng)計量Statisticalanalysisplan統(tǒng)計分析計劃Statisticalanalysisplan統(tǒng)計參數(shù)計劃書Statisticalanalysisplan

16、,SAP統(tǒng)計分析計劃Statisticalmodel統(tǒng)計模型Statisticaltables統(tǒng)計分析表Stratified分層Studyaudit研究稽查Subgroup亞組Sub-investigator助理研究者Subject受試者Subjectdiary受試者日t己Subjectenrollment受試者入選Subjectenrollmentlog受試者入選表Subjectidentificationcode,SIC受試者識別代碼Subjectrecruitment受試者招募Subjectscreeninglog受試者篩選表Superiority檢驗Survivalanalysis生存分析SXRD單晶X射線衍射Systemaudit系統(tǒng)稽查T1/2消除半衰期Targetvariable目標(biāo)變量TBIL總膽紅素T-CHO總、膽固醇TG熱重分析TLC、HPLC制備色譜Tmax峰時間TP總蛋白Transformation變量變換Treatmentgroup試驗組Trialerror試驗誤差Trialmasterfile試驗總檔案Tria