臨床試驗(yàn)常用中英文詞匯

臨床試驗(yàn)常用中英文詞匯SFDAGlossary：GCP，GLP，TRIALAccuracy準(zhǔn)確度Activecontrol，AC陽性對(duì)照，活性對(duì)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(jì)分析的數(shù)據(jù)集Approval批準(zhǔn)Assistantinvestigator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Auditorinspection稽查／視察Auditreport稽查報(bào)告Auditor稽查員Bias偏性，偏倚Bioequivalence生物等效應(yīng)Blankcontrol空白對(duì)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(bào)告表Casereportform/caserecordform，CRF病例報(bào)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(yàn)的總結(jié)報(bào)告Clinicaltrial臨床試驗(yàn)Clinicaltrialapplication，CTA臨床試驗(yàn)申請(qǐng)Clinicaltrialexemption，CTX臨床試驗(yàn)免責(zé)Clinicaltrialprotocol，CTP臨床試驗(yàn)方案Clinicaltrial/studyreport臨床試驗(yàn)報(bào)告Cmax峰濃度Co-investigator合作研究者Comparison對(duì)照Compliance依從性Compositevariable復(fù)合變量Computer-assistedtrialdesign，CATD計(jì)算機(jī)輔助試驗(yàn)設(shè)計(jì)Confidenceinterval可信區(qū)間Confidencelevel置信水平Consistencytest一致性檢驗(yàn)Contractresearchorganization，CRO合同研究組織Contract/agreement協(xié)議／合同Controlgroup對(duì)照組Coordinatingcommittee協(xié)調(diào)委員會(huì)Crea肌酐CRF（casereportform）病例報(bào)告表Crossoverdesign交叉設(shè)計(jì)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(jì)分析DF波動(dòng)系統(tǒng)Dichotomies二分類Diviation偏差Documentation記錄／文件Dose-reactionrelation劑量－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(jì)Effectiveness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(diǎn)Endpointcriteria/measurement終點(diǎn)指標(biāo)Equivalence等效性Essentialdocumentation必須文件Ethicscommittee倫理委員會(huì)Excellent顯效Exclusioncriteria排除標(biāo)準(zhǔn)Factorialdesign析因設(shè)計(jì)Failure無效，失敗Finalpoint終點(diǎn)Fixed-doseprocedure固定劑量法Forcedtitration強(qiáng)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(píng)價(jià)變量GLU血糖Goodclinicalpractice，GCP藥物臨床試驗(yàn)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(jì)Healtheconomicevaluation，HEV健康經(jīng)濟(jì)學(xué)評(píng)價(jià)Hypothesistest假設(shè)檢驗(yàn)Hypothesistesting假設(shè)檢驗(yàn)InternationalConferenceofHarmonization，ICH人用藥品注冊(cè)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)Inclusioncriteria入選標(biāo)準(zhǔn)Independentethicscommittee，IEC獨(dú)立倫理委員會(huì)Informationconsentform，ICF知情同意書Informationgathering信息收集Informedconsent，IC知情同意Initialmeeting啟動(dòng)會(huì)議Inspection視察／檢查Institutioninspection機(jī)構(gòu)檢查Institutionreviewboard，IBR機(jī)構(gòu)審查委員會(huì)Intentiontotreat意向治療（——臨床領(lǐng)域）Intention-to–treat，ITT意向性分析（－統(tǒng)計(jì)學(xué)）Interactivevoiceresponsesystem，IVRS互動(dòng)式語音應(yīng)答系統(tǒng)Interimanalysis期中分析Investigator研究者Investigator'sbrochure，IB研究者手冊(cè)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Logiccheck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(duì)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(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（MaximumToleratedDose）最大耐受劑量Multicentertrial多中心試驗(yàn)Multi-centertrial多中心試驗(yàn)Newchemicalentity，NCE新化學(xué)實(shí)體Newdrugapplication，NDA新藥申請(qǐng)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(jì)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(píng)價(jià)Outcomemeasurement結(jié)果指標(biāo)Outlier離群值Parallelgroupdesign平行組設(shè)計(jì)Parameterestimation參數(shù)估計(jì)Parametricstatistics參數(shù)統(tǒng)計(jì)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(duì)照Polytomies多分類Power檢驗(yàn)效能Precision精密度Preclinicalstudy臨床前研究Primaryendpoint主要終點(diǎn)Primaryvariable主要變量Principalinvestigator主要研究者Principleinvestigator，PI主要研究者Productlicense，PL產(chǎn)品許可證Protocol試驗(yàn)方案Protocol試驗(yàn)方案Protocolamendment方案補(bǔ)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(duì)標(biāo)準(zhǔn)差Runin準(zhǔn)備期Safetyevaluation安全性評(píng)價(jià)Safetyset安全性評(píng)價(jià)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(yàn)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(yàn)水準(zhǔn)Simplerandomization簡單隨機(jī)Singleblinding單盲Single-blinding單盲Siteaudit試驗(yàn)機(jī)構(gòu)稽查SOP試驗(yàn)室的標(biāo)準(zhǔn)操作規(guī)程Sourcedataverification，SDV原始數(shù)據(jù)核準(zhǔn)Subjectrecruitment受試者招募Subjectscreeninglog受試者篩選表Superiority檢驗(yàn)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T－BIL總膽紅素T－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Treatmentgroup試驗(yàn)組Trialerror試驗(yàn)誤差Trialmasterfile試驗(yàn)總檔案Trialobjective試驗(yàn)?zāi)康腡rialsite試