臨床試驗(yàn)常用中英文詞匯

(完整)臨床驗(yàn)常用中英文詞匯(完整)臨床驗(yàn)常用中文詞匯編輯整理：尊敬的讀者朋友們：這里是精品文檔編輯中心，本文檔內(nèi)容是由我和我的同事精心編輯整理后發(fā)布的，發(fā)布之前我們對(duì)文中內(nèi)容進(jìn)行仔細(xì)校對(duì)，但是難免會(huì)有疏漏的地方，但是任然希望（(整)床試驗(yàn)常用中英文詞匯）的內(nèi)容能夠給您的工作和學(xué)習(xí)帶來便利。同時(shí)也真誠(chéng)的希望收到您的建議和反饋，這將是我們進(jìn)步的源泉，前進(jìn)的動(dòng)力。本文可編輯可修改，如果覺得對(duì)您有幫助請(qǐng)收藏以便隨時(shí)查閱，最后祝您生活愉快業(yè)績(jī)進(jìn)步，以下為(完整臨床試驗(yàn)常用中英文詞匯的全部?jī)?nèi)容。

(完整)臨床驗(yàn)常用中英文詞匯SFDAGlossary：GCP，GLP，TRIALAccuracy準(zhǔn)確度Activecontrol，AC陽(yáng)對(duì)照，活性對(duì)照AdversedrugreactionADR藥不良反應(yīng)Adverseevent，AE不良事件Adversemedicalevents不良醫(yī)學(xué)事件Adversereaction物不良反應(yīng)Alb白蛋白ALD（ApproximateLethal近似致死劑量ALP堿性磷酸酶Alphaspendingfunction消函數(shù)ALT丙氨酸氨基轉(zhuǎn)換Analysissets統(tǒng)計(jì)析的數(shù)據(jù)集Approval批準(zhǔn)Assistantinvestigator理研究者AST天門冬酸氨基轉(zhuǎn)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Auditinspection稽／視察Auditreport查告Auditor稽員Bias偏性，偏倚Bioequivalence生等效應(yīng)

(完整)臨床驗(yàn)常用中英文詞匯Blankcontrol空白照Blindcodes編制盲Blindreview態(tài)核Blindreview態(tài)查BlindingmethodBlinding/masking法，設(shè)盲Block分段Block層Blocksize每段的度BUN尿素氮Carryovereffect滯效應(yīng)Casehistory病歷Casereport病報(bào)告表Casereportcaserecord，CRF例報(bào)告表,病例錄表Categoricalvariable分變量Cav平均濃度CD圓二色譜CL清除率Clinicalequivalence臨等效應(yīng)Clinicalstudy臨床究Clinicalstudyreport臨床試驗(yàn)的總結(jié)報(bào)告Clinicaltrial臨床驗(yàn)Clinicaltrialapplication，CTA臨床試驗(yàn)申請(qǐng)Clinicaltrialexemption，CTX床試驗(yàn)免責(zé)

(完整)臨床驗(yàn)常用中英文詞匯Clinicaltrialprotocol，CTP臨床試驗(yàn)方案Clinicaltrial/report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)變量Computer—assistedtrialdesignCATD算機(jī)輔助試驗(yàn)設(shè)Confidenceinterval可信區(qū)間Confidencelevel信水平Consistencytest一性檢驗(yàn)Contractresearchorganization，CRO合同研究組織Contract/agreement協(xié)議／合同Controlgroup對(duì)照Coordinatingcommittee協(xié)委員會(huì)Crea肌酐CRF（casereportform例報(bào)告表Crossoverdesign叉設(shè)計(jì)Cross-overstudy叉研究Css穩(wěn)濃度Cure痊愈Datamanagement數(shù)管理Database建立數(shù)據(jù)Descriptivestatisticalanalysis描述性統(tǒng)計(jì)分析

(完整)臨床驗(yàn)常用中英文詞匯DF波動(dòng)系統(tǒng)Dichotomies二分類Diviation偏差Documentation記文件Dose—reactionrelation劑量－反應(yīng)關(guān)系DoubleblindingDoubledummy雙模Doubledummytechnique雙雙模擬技術(shù)Double—blinding雙盲Dropout脫落DSC差示掃描熱量計(jì)Effectiveness療ElectronicdatacaptureEDC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)信件Endpoint終點(diǎn)Endpointcriteria/measurement終點(diǎn)指標(biāo)Equivalence等效性Essentialdocumentation必文件Ethicscommittee倫委員會(huì)Excellent顯效Exclusioncriteria排標(biāo)準(zhǔn)Factorialdesign因設(shè)計(jì)Failure無，失敗

(完整)臨床驗(yàn)常用中英文詞匯Finalpoint終點(diǎn)Fixed—doseprocedure定劑量法Forcedtitration強(qiáng)滴定Fullanalysis全分集GC－FTIR氣相色譜傅利葉紅外聯(lián)用GC－MS氣相色譜－譜聯(lián)用Genericdrug通用藥Globalassessmentvariable局評(píng)價(jià)變量GLU血糖Goodclinicalpractice，GCP物臨床試驗(yàn)質(zhì)量管理規(guī)范GoodmanufacturepracticeGMP品生產(chǎn)質(zhì)量管理規(guī)范Goodnon-clinicallaboratory，GLP藥物非臨床究質(zhì)量管理規(guī)范Groupsequentialdesign組序貫設(shè)計(jì)Healtheconomicevaluation,健康經(jīng)濟(jì)學(xué)評(píng)價(jià)Hypothesistest假檢驗(yàn)Hypothesistesting假檢驗(yàn)InternationalConferenceofHarmonizationICH人用藥注冊(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Improvement好轉(zhuǎn)Inclusioncriteria入標(biāo)準(zhǔn)IndependentethicscommitteeIEC獨(dú)立倫理委員會(huì)Informationconsent，ICF知同意書Informationgathering信息收集

(完整)臨床驗(yàn)常用中英文詞匯Informedconsent,情同意Initialmeeting啟動(dòng)議Inspection視察／查Institutioninspection機(jī)構(gòu)檢查Institutionreviewboard,IBR機(jī)構(gòu)審查委員會(huì)Intentiontreat意向治療（——臨床領(lǐng)域）Intention-to–treat，ITT意性分析（－統(tǒng)計(jì)學(xué)）Interactivevoiceresponsesystem，互動(dòng)式語(yǔ)音應(yīng)答統(tǒng)Interimanalysis中分析Investigator究Investigator'sbrochure，IB究者手冊(cè)IR紅外吸收光譜Ka吸收速率常LastobservationforwardLOCF接近一次觀察的結(jié)LC－MS液相色譜－譜聯(lián)用LD50板數(shù)致死劑量Logiccheck邏輯檢LOQ（LimitofQuantitation）定量限LOCF，Lastobservationcarryforward最近一次觀察的結(jié)轉(zhuǎn)Lostfollowup訪Marketingapproval/authorization上市許可證Matchedpair匹配對(duì)Missingvalue缺失Mixedeffect混合效應(yīng)模式

(完整)臨床驗(yàn)常用中英文詞匯Monitor監(jiān)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)譜用MTD（MaximumToleratedDose）最大耐受劑量Multicentertrial多中心試驗(yàn)Multi—centertrial多心試驗(yàn)Newchemicalentity,NCE新學(xué)實(shí)體NewdrugapplicationNDA新申請(qǐng)NMR核磁共振譜Non-clinicalstudy非臨床研究Non-inferiority非劣效性Non-parametricstatistics非數(shù)統(tǒng)計(jì)方法Obedience依從性O(shè)DR旋光光譜Open-blinding非Open-label非盲Optionaltitration隨滴定Originalmedicalrecord原醫(yī)療記錄Outcome結(jié)Outcomeassessment結(jié)果指標(biāo)評(píng)價(jià)Outcomemeasurement結(jié)果指標(biāo)

(完整)臨床驗(yàn)常用中英文詞匯Outlier離值Parallelgroupdesign平行組設(shè)計(jì)Parameterestimation參數(shù)估計(jì)Parametricstatistics參統(tǒng)計(jì)方法Patientfile病人案Patienthistory病歷Perprotocol，PP符合方案集Placebo安劑Placebocontrol安慰對(duì)照Polytomies多分類Power檢驗(yàn)效能Precision精密度Preclinicalstudy臨床前研究Primaryendpoint要終點(diǎn)Primaryvariable要變量Principalinvestigator要研究者PrincipleinvestigatorPI主要研究者Productlicense,產(chǎn)許可證Protocol試驗(yàn)方案Protocol試驗(yàn)方案Protocolamendment方補(bǔ)正QualityassuranceQAU量保證部門Qualityassurance，QA量保證Qualitycontrol,質(zhì)控制

(完整)臨床驗(yàn)常用中英文詞匯Querylist，queryform用疑問表Randomization隨Randomization隨Rangecheck范圍檢Ratingscale量表RegulatoryauthoritiesRA監(jiān)督管理部門Replication可重復(fù)RSD日內(nèi)和日間相對(duì)準(zhǔn)差Run準(zhǔn)備期Safetyevaluation安全性評(píng)價(jià)Safetyset安全性價(jià)的數(shù)據(jù)集Samplesize樣本含Samplesize樣本量樣本大小Scaleorderedcategoricalratings有序分類指標(biāo)Secondaryvariable次變量Sequence試驗(yàn)次序SeriousadverseSAE嚴(yán)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(jiǎn)單隨機(jī)SingleblindingSingle-blinding單盲

(完整)臨床驗(yàn)常用中英文詞匯Siteaudit試驗(yàn)機(jī)稽查SOP試驗(yàn)室的標(biāo)準(zhǔn)操規(guī)程Sourcedataverification，SDV原數(shù)據(jù)核準(zhǔn)Sourcedata，原始數(shù)據(jù)Sourcedocument,SD原文件Specificity特異性Sponsor申者Sponsor—investigator申辦究者Standardcurve標(biāo)準(zhǔn)線Standardoperatingprocedure，SOP準(zhǔn)操作規(guī)程Statistic統(tǒng)計(jì)量Statisticalanalysis統(tǒng)計(jì)分析計(jì)劃Statisticalanalysis統(tǒng)計(jì)參數(shù)計(jì)劃書Statisticalanalysis，SAP計(jì)分析計(jì)劃Statisticalmodel統(tǒng)計(jì)模型Statisticaltables計(jì)分析表Stratified分層Studyaudit研究稽Subgroup亞組Sub-investigator理研究者Subject受者Subjectdiary受試日記Subjectenrollment受試者入選Subjectenrollmentlog受者入選表

(完整)臨床