GCP資料-藥物臨床試驗(yàn)英文詞匯及縮寫

1、【實(shí)用】GCP資料藥物臨床試驗(yàn)英文縮寫縮略語(yǔ)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CRCClinicalResearchCoordinator臨床研究協(xié)調(diào)者CRFCase Report Form病歷報(bào)告表CROContractResearchOrganiza

2、tion合同研究組織CSAClinicalStudyApplication臨床研究申請(qǐng)CTAClinicalTrialApplication臨床試驗(yàn)申請(qǐng)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數(shù)據(jù)安全及監(jiān)控委員藥海無(wú)涯學(xué)無(wú)止境專注醫(yī)學(xué)領(lǐng)域【實(shí)用】GCP資料縮略語(yǔ)英文全稱中文全稱Board會(huì)EDCElectronic Data Capture電子數(shù)據(jù)采集系統(tǒng)EDPElectronicDat

3、aProcessing電子數(shù)據(jù)處理系統(tǒng)FDAFoodandDrugAdministration美國(guó)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GMPGoodManufacturingPractice藥品生產(chǎn)質(zhì)量管理規(guī)范IBInvestigators Brochure研究者手冊(cè)ICInformed Consent知情同意ICFInformed Consent Form知情同意書ICHInternational Conferenceon

4、Harmonization國(guó)際協(xié)調(diào)會(huì)議IDMIndependentDataMonitoring獨(dú)立數(shù)據(jù)監(jiān)察IDMCIndependentData獨(dú)立數(shù)據(jù)監(jiān)察委員會(huì)藥海無(wú)涯學(xué)無(wú)止境專注醫(yī)學(xué)領(lǐng)域【實(shí)用】GCP資料縮略語(yǔ)英文全稱中文全稱Monitoring CommitteeIECIndependentEthicsCommittee獨(dú)立倫理委員會(huì)INDInvestigational New Drug新藥臨床研究IRBInstitutionalReviewBoard機(jī)構(gòu)審查委員會(huì)IVDIn Vitro Diagnostic體外診斷IVRSInteractiveVoiceResponse System互

5、動(dòng)語(yǔ)音應(yīng)答系統(tǒng)MAMarketingApproval/Authorization上市許可證MCAMedicines Control Agency英國(guó)藥品監(jiān)督局MHWMinistry of Health andWelfare日本衛(wèi)生福利部NDANew Drug Application新藥申請(qǐng)NECNew Drug Entity新化學(xué)實(shí)體NIHNational Institutes ofHealth國(guó)家衛(wèi)生研究所（美國(guó)）PIPrincipal Investigator主要研究者PLProduct License產(chǎn)品許可證PMAPre-marketApproval上市前許可（申請(qǐng)）藥海無(wú)涯學(xué)無(wú)止境專

6、注醫(yī)學(xué)領(lǐng)域【實(shí)用】GCP資料縮略語(yǔ)英文全稱中文全稱(Application)PSIStatisticians in thePharmaceutical 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(chǎng)評(píng)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/D

7、ocument原始數(shù)據(jù)/文件SDSubject Diary受試者日記SFDAState Food and DrugAdministration國(guó)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 IdentificationCode受試者識(shí)別代碼藥海無(wú)涯學(xué)無(wú)止境專注醫(yī)學(xué)領(lǐng)域【實(shí)用】GCP資料縮略語(yǔ)英文全稱中文全稱SOPStandardOperatingProcedure標(biāo)準(zhǔn)操作規(guī)

8、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-ICDRAWHOInternationalConference ofDrugRegulatoryAuthoritiesWHO國(guó)際藥品管理當(dāng)局會(huì)議藥海無(wú)涯學(xué)無(wú)止境專注醫(yī)學(xué)領(lǐng)域【實(shí)用】GCP資料藥物臨床試驗(yàn)英文縮寫英文全稱中文全稱Accuracy準(zhǔn)確度Active c

9、ontrol, AC陽(yáng)性對(duì)照活性對(duì)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 LethalDose)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)藥海無(wú)涯學(xué)無(wú)止境專注醫(yī)學(xué)領(lǐng)域【實(shí)用】GCP資料英文全稱中文全稱Assistant investigator助理研究者AST

10、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(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 control空白對(duì)照Blind codes編制盲底Blind review百態(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(zhǎng)度Carryover effect延滯效應(yīng)藥海無(wú)涯學(xué)無(wú)止境專注醫(yī)學(xué)領(lǐng)域【實(shí)用】GCP資料英文全稱中文全稱Case

11、history病歷Case report form/ caserecord 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 report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(qǐng)Clinical trial exemptionCTX臨床試驗(yàn)免責(zé)Clinical trial protocol CTP臨床試驗(yàn)方案Clinical t

12、rial/ study report臨床試驗(yàn)報(bào)告Cmax峰濃度Co-investigator合作研究者Comparison對(duì)照藥海無(wú)涯學(xué)無(wú)止境專注醫(yī)學(xué)領(lǐng)域【實(shí)用】GCP資料英文全稱中文全稱Compliance依從性Composite variable復(fù)合變量Computer-assistedtrialdesign 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)Contractresearchorganization CRO合同研究組織Contract/ agreement協(xié)議/合同Con

13、trol group對(duì)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(kù)藥海無(wú)涯學(xué)無(wú)止境專注醫(yī)學(xué)領(lǐng)域【實(shí)用】GCP資料英文全稱中文全稱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-reaction relation劑量一反應(yīng)

14、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 processingEDP電子數(shù)據(jù)處理系統(tǒng)Emergency envelope應(yīng)急信件End point終點(diǎn) 八、Endpoint Criteria終點(diǎn)指標(biāo)Endpointcriteria/measurement終點(diǎn)指標(biāo)藥海無(wú)涯學(xué)無(wú)止境專注醫(yī)學(xué)領(lǐng)域【實(shí)用】GCP資料英文全稱中文全稱Equivalence等效性Essential Doc

15、umentation必需文件Ethics committee倫理委員會(huì)Excellent顯效Exclusion criteria排除標(biāo)準(zhǔn)Factorial design析因設(shè)計(jì)Failure無(wú)效失敗Final point終點(diǎn) 八、Fixed-dose procedure固定劑量法Forced titration強(qiáng)制滴定Full analysis set全分析集GC-FTIR氣相色譜一傅利葉紅外聯(lián)用GC-MS氣相色譜一質(zhì)譜聯(lián)用Generic drug通用名藥Global assessment variable全局評(píng)價(jià)變量GLU血糖Good clinical practice, GCP藥物臨床試驗(yàn)

16、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Goodnon-clinical藥物非臨床研究質(zhì)量管理規(guī)藥海無(wú)涯學(xué)無(wú)止境專注醫(yī)學(xué)領(lǐng)域【實(shí)用】GCP資料英文全稱中文全稱laboratory practice, GLP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(píng)價(jià)Hypothesis test假設(shè)檢驗(yàn)Hypothesis testing假設(shè)檢驗(yàn)Improvement好轉(zhuǎn)Inclusion Criteria入選標(biāo)準(zhǔn)Inclusion criteria入選標(biāo)準(zhǔn)Indepen

17、dentethicscommittee IEC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)藥海無(wú)涯學(xué)無(wú)止境專注醫(yī)學(xué)領(lǐng)域【實(shí)用】GCP資料英文全稱中文全稱Intention-to - treat ITT意向性分析（一統(tǒng)計(jì)學(xué)）Interactive voice responsesys

18、tem IVRS互動(dòng)式語(yǔ)音應(yīng)答系統(tǒng)Interim analysis期中分析International Conference ofHarmonization ICH人用藥品注冊(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Investigational Product試驗(yàn)藥物Investigator研究者Investigators brochure,IB研究者手冊(cè)Last observation carry forward, LOCF最接近一次觀察的結(jié)轉(zhuǎn)LC-MS液相色譜一質(zhì)譜聯(lián)用LD50板數(shù)致死劑量LOCF, Last observation carry forward最近一次觀察的結(jié)轉(zhuǎn)Logic che

19、ck邏輯檢查L(zhǎng)OQ (Limit of Quantization)定量限Lost of follow up失訪Marketingapproval/上市許可證藥海無(wú)涯學(xué)無(wú)止境專注醫(yī)學(xué)領(lǐng)域【實(shí)用】GCP資料英文全稱中文全稱authorizationMatched pair匹配配對(duì)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MS-MS質(zhì)譜一質(zhì)譜聯(lián)用MTD (Maximum Tolerated Dose)最大耐受劑量M

20、ulti-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(qǐng)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依從性藥海無(wú)涯學(xué)無(wú)止境專注醫(yī)學(xué)領(lǐng)域【實(shí)用】GCP資料英文全稱中文全稱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 Assessment

21、結(jié)果評(píng)價(jià)Outcome assessment結(jié)果指標(biāo)評(píng)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)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Placebo安慰劑Placebo control安慰劑對(duì)照Polytomies多分類Power檢驗(yàn)效能Precision精密度藥海無(wú)涯學(xué)無(wú)止境專注醫(yī)學(xué)領(lǐng)域【實(shí)用】GCP資料英文全稱中文全稱Preclinical st

22、udy臨床前研究Primary endpoint主要終點(diǎn) y、八、Primary variable主要變量Principle investigator PI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 list query form應(yīng)用疑問表Randomization隨機(jī)Range check范圍檢查Rating scale量表Reference Pr

23、oduct參比制劑Regulatory authorities 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Run in準(zhǔn)備期Safety evaluation安全性評(píng)價(jià)藥海無(wú)涯學(xué)無(wú)止境專注醫(yī)學(xué)領(lǐng)域【實(shí)用】GCP資料英文全稱中文全稱Safety set安全性評(píng)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 SA

24、R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(jiǎn)單隨機(jī)Single blinding單目Site 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特異性藥海無(wú)涯學(xué)無(wú)止境專注醫(yī)學(xué)領(lǐng)域【實(shí)用】GCP資料英文全稱中文全稱Sponsor申辦者Sponsor-investigator申辦研究者Standard c

25、urve標(biāo)準(zhǔn)曲線Standardoperatingprocedure 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 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 lo

26、g受試者入選表藥海無(wú)涯學(xué)無(wú)止境專注醫(yī)學(xué)領(lǐng)域【實(shí)用】GCP資料英文全稱中文全稱Subject identification codeSIC受試者識(shí)別代碼Subject Identification CodeList受試者識(shí)別代碼表Subject Recruitment受試者招募Subject screening log受試者篩選表Superiority檢驗(yàn)Survival analysis生存分析SXRD單品乂一射線衍射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 Produc

27、t受試制劑TG熱重分析TLC、 HPLC制備色譜Tmax峰時(shí)間TP總蛋白藥海無(wú)涯學(xué)無(wú)止境專注醫(yī)學(xué)領(lǐng)域【實(shí)用】GCP資料英文全稱中文全稱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 objective試驗(yàn)?zāi)康腡rial site試驗(yàn)場(chǎng)所Triple blinding* 二目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紫外一可見吸

28、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(shì)受試者Wash-out洗脫Washout period洗脫期藥海無(wú)涯學(xué)無(wú)止境專注醫(yī)學(xué)領(lǐng)域【實(shí)用】GCP資料藥海無(wú)涯學(xué)無(wú)止境專注醫(yī)學(xué)領(lǐng)域【實(shí)用】GCP資料實(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% granulocyte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% a

29、llergy 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)胞體積藥海無(wú)涯學(xué)無(wú)止境專注醫(yī)學(xué)領(lǐng)域【實(shí)用】GCP資料英文全稱中文全稱MCHmeancorpusularhemoglobin平均紅細(xì)胞血紅蛋白含量MCHCmeancorpusularhemoglobin concerntration平均紅細(xì)胞血紅蛋白濃度RDW red blood cell volume distribution w

30、idth紅細(xì)胞分布寬度變異PLT/BPCplateletcount/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 bilirubin尿膽紅素URO urobilinogen尿膽原藥海無(wú)涯學(xué)無(wú)止境專注醫(yī)學(xué)領(lǐng)域【實(shí)用】GCP資料

31、英文全稱中文全稱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UREA urea尿素CREA creati

32、nine肌肝UA uric acid尿酸GLU glucose血糖ALT alanine amiotransferase丙氨酸氨基轉(zhuǎn)移酶ASTaspartate門冬氨酸氨基轉(zhuǎn)移酶藥海無(wú)涯學(xué)無(wú)止境專注醫(yī)學(xué)領(lǐng)域【實(shí)用】GCP資料英文全稱中文全稱aminotransferaseGGTY-glutamyltranspeptadase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 dehydrogenasea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-chigh-densitylipoprotein cholesterol高密度脂蛋白LDL-clow-densitylipoprotein cholesterol低密度脂蛋白VLDL very low-dens