藥物臨床試驗(yàn)英文縮寫匯編

-.z.藥物臨床試驗(yàn)英文縮寫序號縮略語中文全稱英文全稱1ADE藥物不良事件AdverseDrugEvent2ADR藥物不良反響AdverseDrugReaction3AE不良事件AdverseEvent4AI助理研究者AssistantInvestigator5BMI體質(zhì)指數(shù)BodyMassInde*6CI合作研究者Co-investigator7COI協(xié)調(diào)研究者CoordinatingInvestigator8CRC臨床研究協(xié)調(diào)者ClinicalResearchCoordinator9CRF病歷報(bào)告表CaseReportForm10CRO合同研究組織ContractResearchOrganization11CSA臨床研究申請ClinicalStudyApplication12CTA臨床試驗(yàn)申請ClinicalTrialApplication13CT*臨床試驗(yàn)免責(zé)ClinicalTrialE*emption14CTP臨床試驗(yàn)方案ClinicalTrialProtocol15CTR臨床試驗(yàn)報(bào)告ClinicalTrialReport16DSMB數(shù)據(jù)平安及監(jiān)控委員會DataSafetyandmonitoringBoardEC倫理委員會EthicsCommittee17EDC電子數(shù)據(jù)采集系統(tǒng)ElectronicDataCapture18EDP電子數(shù)據(jù)處理系統(tǒng)ElectronicDataProcessing19FDA美國食品與藥品管理局FoodandDrugAdministration20FR總結(jié)報(bào)告FinalReport21GCP藥物臨床試驗(yàn)質(zhì)量管理標(biāo)準(zhǔn)GoodClinicalPractice22GLP藥物非臨床試驗(yàn)質(zhì)量管理標(biāo)準(zhǔn)GoodLaboratoryPractice23GMP藥品生產(chǎn)質(zhì)量管理標(biāo)準(zhǔn)GoodManufacturingPractice24IB研究者手冊Investigator’sBrochure25IC知情同意InformedConsent26ICF知情同意書InformedConsentForm27ICH國際協(xié)調(diào)會議InternationalConferenceonHarmonization28IDM獨(dú)立數(shù)據(jù)監(jiān)察IndependentDataMonitoring29IDMC獨(dú)立數(shù)據(jù)監(jiān)察委員會IndependentDataMonitoringCommittee30IEC獨(dú)立倫理委員會IndependentEthicsCommittee31IND新藥臨床研究InvestigationalNewDrug32IRB機(jī)構(gòu)審查委員會InstitutionalReviewBoard33IVD體外診斷InVitroDiagnostic34IVRS互動語音應(yīng)答系統(tǒng)InteractiveVoiceResponseSystem35MA上市許可證MarketingApproval/Authorization36MCA英國藥品監(jiān)視局MedicinesControlAgency37MHW日本衛(wèi)生福利部MinistryofHealthandWelfare38NDA新藥申請NewDrugApplication39NEC新化學(xué)實(shí)體NewDrugEntity40NIH國家衛(wèi)生研究所〔美國〕NationalInstitutesofHealth41PI主要研究者PrincipalInvestigator42PL產(chǎn)品許可證ProductLicense43PMA上市前許可〔申請〕Pre-marketApproval(Application)44PSI制藥業(yè)統(tǒng)計(jì)學(xué)家協(xié)會StatisticiansinthePharmaceuticalIndustry45QA質(zhì)量保證QualityAssurance46QC質(zhì)量控制QualityControl47RA監(jiān)視管理部門RegulatoryAuthorities48SA現(xiàn)場評估SiteAssessment49SAE嚴(yán)重不良事件SeriousAdverseEvent50SAP統(tǒng)計(jì)分析方案StatisticalAnalysisPlan51SAR嚴(yán)重不良反響SeriousAdverseReaction52SD原始數(shù)據(jù)/文件SourceData/Document53SD受試者日記SubjectDiary54SFDA國家食品藥品監(jiān)視管理局StateFoodandDrugAdministration55SDV原始數(shù)據(jù)核準(zhǔn)SourceDataVerification56SEL受試者入選表SubjectEnrollmentLog57SI助理研究者Sub-investigator58SI申辦研究者Sponsor-Investigator59SIC受試者識別代碼SubjectIdentificationCode60SOP標(biāo)準(zhǔn)操作規(guī)程StandardOperatingProcedure60SPL研究人員名單StudyPersonnelList62SSL受試者篩選表SubjectScreeningLog63T&R受試和參比試劑TestandReferenceProduct64UAE預(yù)料外不良事件Une*pectedAdverseEvent65WHO世界衛(wèi)生組織WorldHealthOrganization66WHO-ICDRAWHO國際藥品管理當(dāng)局會議WHOInternationalConferenceofDrugRegulatoryAuthorities藥物臨床試驗(yàn)英文縮寫英文全稱中文全稱Accuracy準(zhǔn)確度Activecontrol,AC陽性對照活性對照Adversemedicalevents不良醫(yī)學(xué)事件Adversereaction藥物不良反響Alb白蛋白ALD〔Appro*imateLethalDose〕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層Blocksize每段的長度Carryovereffect延滯效應(yīng)Casehistory病歷Categoricalvariable分類變量Cav平均濃度CD圓二色譜CL去除率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)Cma*峰濃度Co-investigator合作研究者Comparison對照Compliance依從性Compositevariable復(fù)合變量Computer-assistedtrialdesignCATD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)Contract/agreement協(xié)議／合同Controlgroup對照組Coordinatingcommittee協(xié)調(diào)委員會Crea肌酐CRF(casereportform)病例報(bào)告表Crossoverdesign穿插設(shè)計(jì)Cross-overStudy穿插研究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波動系統(tǒng)Dichotomies二分類Diviation偏差Documentation記錄／文件Dose-reactionrelation劑量－反響關(guān)系Doubledummy雙模擬Doubledummytechnique雙盲雙模擬技術(shù)Dropout脫落DSC差示掃描熱量計(jì)Effectiveness療效ElectronicdatacaptureEDC電子數(shù)據(jù)采集系統(tǒng)ElectronicdataprocessingEDP電子數(shù)據(jù)處理系統(tǒng)Emergencyenvelope應(yīng)急信件Endpoint終點(diǎn)EndpointCriteria終點(diǎn)指標(biāo)Endpointcriteria/measurement終點(diǎn)指標(biāo)Equivalence等效性EssentialDocumentation必需文件Ethicscommittee倫理委員會E*cellent顯效E*clusioncriteria排除標(biāo)準(zhǔn)Factorialdesign析因設(shè)計(jì)Failure無效失敗Finalpoint終點(diǎn)Fi*ed-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全局評價變量GLU血糖Groupsequentialdesign成組序貫設(shè)計(jì)Healtheconomicevaluation,HEV安康經(jīng)濟(jì)學(xué)評價Hypothesistest假設(shè)檢驗(yàn)Hypothesistesting假設(shè)檢驗(yàn)Improvement好轉(zhuǎn)Inclusioncriteria入選標(biāo)準(zhǔn)InformationGathering信息收集InformedconsentIC知情同意Initialmeeting啟動會議Inspection檢察/視察Institutioninspection機(jī)構(gòu)檢查Institutionreviewboard,IBR機(jī)構(gòu)審查委員會Intention-to–treatITT意向性分析(－統(tǒng)計(jì)學(xué)〕InteractivevoiceresponsesystemIVRS互動式語音應(yīng)答系統(tǒng)Interimanalysis期中分析InternationalConferenceofHarmonizationICH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InvestigationalProduct試驗(yàn)藥物Investigator研究者Investigator’sbrochure,IB研究者手冊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LOCF,Lastobservationcarryforward最近一次觀察的結(jié)轉(zhuǎn)Logiccheck邏輯檢查LOQ(LimitofQuantization)定量限Lostoffollowup失訪Marketingapproval/authorization上市許可證Matchedpair匹配配對Missingvalue缺失值Mi*edeffectmodel混合效應(yīng)模式Monitor監(jiān)察員Monitoring監(jiān)查MonitoringPlan監(jiān)察方案MonitoringReport監(jiān)察報(bào)告MRT平均滯留時間MS質(zhì)譜MS－MS質(zhì)譜－質(zhì)譜聯(lián)用MTD〔Ma*imumToleratedDose〕最大耐受劑量Multi-centerTrial多中心試驗(yàn)NewchemicalentityNCE新化學(xué)實(shí)體NewdrugapplicationNDA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(jì)方法Obedience依從性O(shè)DR旋光光譜Open-label非盲Optionaltitration隨意滴定Originalmedicalrecord原始醫(yī)療記錄Outcome結(jié)果OutcomeAssessment結(jié)果評價Outcomeassessment結(jié)果指標(biāo)評價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PerprotocolPP符合方案集Placebo撫慰劑Placebocontrol撫慰劑對照Polytomies多分類Power檢驗(yàn)效能Precision精細(xì)度Preclinicalstudy臨床前研究Primaryendpoint主要終點(diǎn)Primaryvariable主要變量PrincipleinvestigatorPI主要研究者ProductlicensePL產(chǎn)品許可證Protocol試驗(yàn)方案ProtocolAmendments修正案QualityassuranceQA質(zhì)量保證QualityassuranceunitQAU質(zhì)量保證部門QualitycontrolQC質(zhì)量控制Querylistqueryform應(yīng)用疑問表Randomization隨機(jī)Rangecheck范圍檢查Ratingscale量表ReferenceProduct參比制劑RegulatoryauthoritiesRA監(jiān)視管理部門Replication可重復(fù)RSD日內(nèi)和日間相對標(biāo)準(zhǔn)差Runin準(zhǔn)備期Safetyevaluation平安性評價Safetyset平安性評價的數(shù)據(jù)集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SeriousadverseeventSAE嚴(yán)重不良事件SeriousadversereactionSAR嚴(yán)重不良反響Seriousness嚴(yán)重性Severity嚴(yán)重程度Severity嚴(yán)重程度Significantlevel檢驗(yàn)水準(zhǔn)SimpleRandomization簡單隨機(jī)Singleblinding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SourcedataSD原始數(shù)據(jù)SourcedataverificationSDV原始數(shù)據(jù)核準(zhǔn)SourcedocumentSD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StandardoperatingprocedureSOP標(biāo)準(zhǔn)操作規(guī)程Statistic統(tǒng)計(jì)量Statisticalanalysisplan統(tǒng)計(jì)分析方案Statisticalmodel統(tǒng)計(jì)模型Statisticaltables統(tǒng)計(jì)分析表Stratified分層StudyAudit研究稽查Studyaudit研究稽查StudySite研究中心Subgroup亞組Sub-investigator助理研究者Subject受試者Subject受試者Subjectdiary受試者日記SubjectEnrollment受試者入選Subjectenrollmentlog受試者入選表SubjectidentificationcodeSIC受試者識別代碼SubjectIdentificationCodeList受試者識別代碼表SubjectRecruitment受試者招募Subjectscreeninglog受試者篩選表Superiority檢驗(yàn)Survivalanalysis生存分析S*RD單晶*－射線衍射Systemaudit系統(tǒng)稽查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TestProduct受試制劑TG熱重分析TLC、HPLC制備色譜Tma*峰時間TP總蛋白Transformation變量變換Treatmentgroup試驗(yàn)組Trialerror試驗(yàn)誤差TrialInitialMeeting試驗(yàn)啟動會議TrialMasterFile試驗(yàn)總檔案Trialobjective試驗(yàn)?zāi)康腡rialsite試驗(yàn)場所Tripleblinding三盲Twoone-sidetest雙單側(cè)檢驗(yàn)Un-blinding揭盲Une*pectedadverseeventUAE預(yù)料外不良事件UV－VIS紫外－可見吸收光譜Variability變異Variable變量Visualanalogyscale直觀類比打分法Visualcheck人工檢查Vulnerablesubject弱勢受試者Wash-out洗脫Washoutperiod洗脫期研究者〔Investigator〕，實(shí)施臨床試驗(yàn)并對臨床試驗(yàn)的質(zhì)量及受試者平安和權(quán)益的負(fù)責(zé)者。研究者必須經(jīng)過資格審查，具有臨床試驗(yàn)的專業(yè)特長、資格和能力。協(xié)調(diào)研究者〔CoordinatingInvestigator〕，在多中心臨床試驗(yàn)中負(fù)責(zé)協(xié)調(diào)參加各中心研究者工作的一名研究者。申辦者〔Sponsor〕，發(fā)起一項(xiàng)臨床試驗(yàn)，并對該試驗(yàn)的啟動、管理、財(cái)務(wù)和監(jiān)查負(fù)責(zé)的公司、機(jī)構(gòu)或組織。監(jiān)查員〔Monitor〕，由申辦者任命并對申辦者負(fù)責(zé)的具備相關(guān)知識的人員，其任務(wù)是監(jiān)查和報(bào)告試驗(yàn)的進(jìn)展情況和核實(shí)數(shù)據(jù)?；椤睞udit〕，指由不直接涉及試驗(yàn)的人員所進(jìn)展的一種系統(tǒng)性檢查，以評價試驗(yàn)的實(shí)施、數(shù)據(jù)的記錄和分析是否與試驗(yàn)方案、標(biāo)準(zhǔn)操作規(guī)程以及藥物臨床試驗(yàn)相關(guān)法規(guī)要求相符。視察〔Inspection〕，藥品監(jiān)視管理部門對一項(xiàng)臨床試驗(yàn)的有關(guān)文件、設(shè)施、記錄和其它方面進(jìn)展官方審閱，視察可以在試驗(yàn)單位、申辦者所在地或合同研究組織所在地進(jìn)展。病例報(bào)告表〔CaseReportForm,CRF〕，指按試驗(yàn)方案所規(guī)定設(shè)計(jì)的一種文件，用以記錄每一名受試者在試驗(yàn)過程中的數(shù)據(jù)。試驗(yàn)用藥品〔InvestigationalProduct〕，用于臨床試驗(yàn)中的試驗(yàn)藥物、對照藥品或撫慰劑。不良事件〔AdverseEvent〕，病人或臨床試驗(yàn)受試者承受一種藥品后出現(xiàn)的不良醫(yī)學(xué)事件，但并不一定與治療有因果關(guān)系。嚴(yán)重不良事件〔SeriousAdverseEvent〕，臨床試驗(yàn)過程中發(fā)生需住院治療、延長住院時間、傷殘、影響工作能力、危及生命或死亡、導(dǎo)致先天畸形等事件。標(biāo)準(zhǔn)操作規(guī)程〔StandardOperatingProcedure,SOP〕，為有效地實(shí)施和完成*一臨床試驗(yàn)中每項(xiàng)工作所擬定的標(biāo)準(zhǔn)和詳細(xì)的書面規(guī)程。設(shè)盲〔Blinding/Masking〕，臨床試驗(yàn)中使一方或多方不知道受試者治療分配的程序。單盲指受試者不知，雙盲指受試者、研究者、監(jiān)查員或數(shù)據(jù)分析者均不知治療分配。合同研究組織〔ContractResearchOrganization,CRO〕，一種學(xué)術(shù)性或商業(yè)性的科學(xué)機(jī)構(gòu)。申辦者可委托其執(zhí)行臨床試驗(yàn)中的*些工作和任務(wù)，此種委托必須作出書面規(guī)定。實(shí)驗(yàn)室檢查英文縮寫英文全稱中文全稱血常規(guī)WBCwhitebloodcellcount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%allergylymphocyte變異淋巴細(xì)胞百分比ST%中性桿狀粒細(xì)胞百分比RBCredbloodcell紅細(xì)胞計(jì)數(shù)HGBhemoglobin血紅蛋白HCThematocrit紅細(xì)胞比積紅細(xì)胞比積MCVmeancorpusularvolume平均紅細(xì)胞體積MCHmeancorpusularhemoglobin平均紅細(xì)胞血紅蛋白含量MCHCmeancorpusularhemoglobinconcerntration平均紅細(xì)胞血紅蛋白濃度RDWredbloodcellvolumedistributionwidth紅細(xì)胞分布寬度變異PLT/BPCplateletcount/bloodplateletcount血小板計(jì)數(shù)MPVmeanplateletvolume平均血小板體積PCTplateletocrit血小板比積PDWplateletdistributionwidth血小板分布寬度尿便常規(guī)PHacidity酸堿度NITnitrite亞硝酸鹽GLUglucose尿糖SGspecificgravity比重PROprotein尿蛋白BLDblood隱血BILbilirubin尿膽紅素UROurobilinogen尿膽原WBCwhitebloodcell白細(xì)胞addish計(jì)數(shù)addishcount艾迪氏計(jì)數(shù)/HPhighpowerobjective每高倍視野/LPlowpowerobjective每低倍視野OBoccultbloodtest大便隱血試驗(yàn)體液常規(guī)CSFcerebrospinal腦積夜Pandypandy龐氏試驗(yàn)生化檢驗(yàn)TBtotalbilirubin總膽紅素DBdirectbilirubin直接膽紅素TPtotalprotein總蛋白ALBalbumin白蛋白GLOBglobulin球蛋白UREAurea尿素CREAcreatinine肌肝UAuricacid尿酸GLUglucose血糖ALTalanineamiotransferase丙氨酸氨基轉(zhuǎn)移酶ASTaspartateaminotransferase門冬氨酸氨基轉(zhuǎn)移酶GGTγ-glutamyltranspeptadase谷氨酰轉(zhuǎn)肽酶CKcreatinekinase肌酸肌酶CK-MBcreatinekinase-MB肌酸肌酶同工酶LDHlactatedehydrogenase乳酸脫氫酶α-HBD