臨床試驗(yàn)以及實(shí)驗(yàn)室中常見的中英文名詞及縮寫

中國創(chuàng)新藥咨詢與服務(wù)先鋒 CRO臨床試驗(yàn)以及實(shí)驗(yàn)室中常見的英文縮寫藥物臨床試驗(yàn)英文縮寫縮略語 英文全稱ADE AdverseDrugEventADR AdverseDrugReactionAE AdverseEventAI AssistantInvestigatorBMI BodyMassIndexCI Co-investigatorCOI CoordinatingInvestigatorCRC ClinicalResearchCoordinatorCRF CaseReportFormCRO ContractResearchOrganizationCSA ClinicalStudyApplicationCTA ClinicalTrialApplicationCTX ClinicalTrialExemptionCTP ClinicalTrialProtocolCTR ClinicalTrialReportDSMB DataSafetyandmonitoringBoardEDC ElectronicDataCaptureEDP ElectronicDataProcessingFDA FoodandDrugAdministrationFR FinalReportGCP GoodClinicalPracticeGCP GoodLaboratoryPracticeGMP GoodManufacturingPracticeIB Investigator Brochure’sIC InformedConsentICF InformedConsentFormICH InternationalConferenceonHarmonizationIDM IndependentDataMonitoringIDMC IndependentDataMonitoringCommitteeIEC IndependentEthicsCommitteeIND InvestigationalNewDrugIRB InstitutionalReviewBoardIVD InVitroDiagnosticIVRS InteractiveVoiceResponseSystemMA MarketingApproval/AuthorizationMCA MedicinesControlAgencyMHW MinistryofHealthandWelfareNDA NewDrugApplicationNEC NewDrugEntityNIH NationalInstitutesofHealth

中文全稱藥物不良事件藥物不良反應(yīng)不良事件助理研究者體質(zhì)指數(shù)合作研究者協(xié)調(diào)研究者臨床研究協(xié)調(diào)者病歷報(bào)告表合同研究組織臨床研究申請臨床試驗(yàn)申請臨床試驗(yàn)免責(zé)臨床試驗(yàn)方案臨床試驗(yàn)報(bào)告數(shù)據(jù)安全及監(jiān)控委員會(huì)電子數(shù)據(jù)采集系統(tǒng)電子數(shù)據(jù)處理系統(tǒng)美國食品與藥品管理局總結(jié)報(bào)告藥物臨床試驗(yàn)質(zhì)量管理規(guī)范藥物非臨床試驗(yàn)質(zhì)量管理規(guī)范藥品生產(chǎn)質(zhì)量管理規(guī)范研究者手冊知情同意知情同意書國際協(xié)調(diào)會(huì)議獨(dú)立數(shù)據(jù)監(jiān)察獨(dú)立數(shù)據(jù)監(jiān)察委員會(huì)獨(dú)立倫理委員會(huì)新藥臨床研究機(jī)構(gòu)審查委員會(huì)體外診斷互動(dòng)語音應(yīng)答系統(tǒng)上市許可證英國藥品監(jiān)督局日本衛(wèi)生福利部新藥申請新化學(xué)實(shí)體國家衛(wèi)生研究所（美國）縮略語 英文全稱PI PrincipalInvestigatorPL ProductLicensePMA Pre-marketApproval(Application)PSI StatisticiansinthePharmaceuticalIndustryQA QualityAssuranceQC QualityControlRA RegulatoryAuthoritiesSA SiteAssessmentSAE SeriousAdverseEventSAP StatisticalAnalysisPlanSAR SeriousAdverseReactionSD SourceData/DocumentSD SubjectDiarySFDA StateFoodandDrugAdministrationSDV SourceDataVerificationSEL SubjectEnrollmentLogSI Sub-investigatorSI Sponsor-InvestigatorSIC SubjectIdentificationCodeSOP StandardOperatingProcedureSPL StudyPersonnelListSSL SubjectScreeningLogT&R TestandReferenceProductUAE UnexpectedAdverseEventWHO WorldHealthOrganizationWHO-ICDRA WHOInternationalConferenceofDrugRegulatoryAuthorities

中文全稱主要研究者產(chǎn)品許可證上市前許可（申請）制藥業(yè)統(tǒng)計(jì)學(xué)家協(xié)會(huì)質(zhì)量保證質(zhì)量控制監(jiān)督管理部門現(xiàn)場評(píng)估嚴(yán)重不良事件統(tǒng)計(jì)分析計(jì)劃嚴(yán)重不良反應(yīng)原始數(shù)據(jù)/文件受試者日記國家食品藥品監(jiān)督管理局原始數(shù)據(jù)核準(zhǔn)受試者入選表助理研究者申辦研究者受試者識(shí)別代碼標(biāo)準(zhǔn)操作規(guī)程研究人員名單受試者篩選表受試和參比試劑預(yù)料外不良事件世界衛(wèi)生組織WHO國際藥品管理當(dāng)局會(huì)議藥物臨床試驗(yàn)英文縮寫英文全稱中文全稱Accuracy準(zhǔn)確度Activecontrol,AC陽性對(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層Blocksize每段的長度Carryovereffect延滯效應(yīng)Casehistory病歷Casereportform/caserecordformCRF病例報(bào)告表病例記錄表Categoricalvariable分類變量英文全稱CavCDCLClinicalequivalenceClinicalstudyClinicalstudyreportClinicaltrialClinicaltrialapplication CTAClinicaltrialexemption CTXClinicaltrialprotocolCTPClinicaltrial/studyreportCmaxCo-investigatorComparisonComplianceCompositevariableComputer-assistedtrialdesignCATDConfidenceintervalConfidencelevelConsistencytestContractresearchorganizationCROContract/agreementControlgroupCoordinatingcommitteeCreaCRF(casereportform)CrossoverdesignCross-overStudyCssCureDatamanagementDatabaseDescriptivestatisticalanalysisDFDichotomiesDiviationDocumentation

中文全稱平均濃度圓二色譜清除率臨床等效應(yīng)臨床研究臨床試驗(yàn)的總結(jié)報(bào)告臨床試驗(yàn)臨床試驗(yàn)申請臨床試驗(yàn)免責(zé)臨床試驗(yàn)方案臨床試驗(yàn)報(bào)告峰濃度合作研究者對(duì)照依從性復(fù)合變量計(jì)算機(jī)輔助試驗(yàn)設(shè)計(jì)可信區(qū)間置信水平一致性檢驗(yàn)合同研究組織協(xié)議／合同對(duì)照組協(xié)調(diào)委員會(huì)肌酐病例報(bào)告表交叉設(shè)計(jì)交叉研究穩(wěn)濃度痊愈數(shù)據(jù)管理建立數(shù)據(jù)庫描述性統(tǒng)計(jì)分析波動(dòng)系統(tǒng)二分類偏差記錄／文件英文全稱Dose-reactionrelationDoubledummyDoubledummytechniqueDropoutDSCEffectivenessElectronicdatacaptureEDCElectronicdataprocessingEDPEmergencyenvelopeEndpointEndpointCriteriaEndpointcriteria/measurementEquivalenceEssentialDocumentationEthicscommitteeExcellentExclusioncriteriaFactorialdesignFailureFinalpointFixed-doseprocedureForcedtitrationFullanalysissetGC－FTIRGC－MSGenericdrugGlobalassessmentvariableGLUGoodclinicalpractice,GCPGoodmanufacturepractice,GMPGoodnon-clinicallaboratorypractice,GLPGroupsequentialdesignHealtheconomicevaluation,HEVHypothesistestHypothesistestingImprovementInclusionCriteria

中文全稱劑量－反應(yīng)關(guān)系雙模擬雙盲雙模擬技術(shù)脫落差示掃描熱量計(jì)療效電子數(shù)據(jù)采集系統(tǒng)電子數(shù)據(jù)處理系統(tǒng)應(yīng)急信件終點(diǎn)終點(diǎn)指標(biāo)終點(diǎn)指標(biāo)等效性必需文件倫理委員會(huì)顯效排除標(biāo)準(zhǔn)析因設(shè)計(jì)無效失敗終點(diǎn)固定劑量法強(qiáng)制滴定全分析集氣相色譜－傅利葉紅外聯(lián)用氣相色譜－質(zhì)譜聯(lián)用通用名藥全局評(píng)價(jià)變量血糖藥物臨床試驗(yàn)質(zhì)量管理規(guī)范藥品生產(chǎn)質(zhì)量管理規(guī)范藥物非臨床研究質(zhì)量管理規(guī)范成組序貫設(shè)計(jì)健康經(jīng)濟(jì)學(xué)評(píng)價(jià)假設(shè)檢驗(yàn)假設(shè)檢驗(yàn)好轉(zhuǎn)入選表準(zhǔn)英文全稱InclusioncriteriaIndependentethicscommittee IECInformationconsentform ICFInformationGatheringInformedconsentICInitialmeetingInspectionInstitutioninspectionInstitutionreviewboard,IBRIntention-to–treat ITTInteractivevoiceresponsesystem IVRSInterimanalysisInternationalConferenceofHarmonizationICHInvestigationalProductInvestigatorInvestigator brochure,’sIBLastobservationcarryforward,LOCFLC－MSLD50LOCF,LastobservationcarryforwardLogiccheckLOQ(LimitofQuantization)LostoffollowupMarketingapproval/authorizationMatchedpairMissingvalueMixedeffectmodelMonitorMonitoringMonitoringPlanMonitoringReportMRTMSMS－MSMTD（MaximumToleratedDose）Multi-centerTrial

中文全稱入選標(biāo)準(zhǔn)獨(dú)立倫理委員會(huì)知情同意書信息收集知情同意啟動(dòng)會(huì)議檢察/視察機(jī)構(gòu)檢查機(jī)構(gòu)審查委員會(huì)意向性分析(－統(tǒng)計(jì)學(xué)）互動(dòng)式語音應(yīng)答系統(tǒng)期中分析人用藥品注冊技術(shù)要求國際技術(shù)協(xié)調(diào)會(huì)國際協(xié)調(diào)會(huì)議試驗(yàn)藥物研究者研究者手冊最接近一次觀察的結(jié)轉(zhuǎn)液相色譜－質(zhì)譜聯(lián)用板數(shù)致死劑量最近一次觀察的結(jié)轉(zhuǎn)邏輯檢查定量限失訪上市許可證匹配配對(duì)缺失值混合效應(yīng)模式監(jiān)察員監(jiān)查監(jiān)察計(jì)劃監(jiān)察報(bào)告平均滯留時(shí)間質(zhì)譜質(zhì)譜－質(zhì)譜聯(lián)用最大耐受劑量多中心試驗(yàn)英文全稱Newchemicalentity NCENewdrugapplication NDANMRNon-clinicalStudyNon-inferiorityNon-parametricstatisticsObedienceODROpen-labelOptionaltitrationOriginalmedicalrecordOutcomeOutcomeAssessmentOutcomeassessmentOutcomemeasurementOutlierParallelgroupdesignParameterestimationParametricstatisticsPatientfilePatienthistoryPerprotocol PPPlaceboPlacebocontrolPolytomiesPowerPrecisionPreclinicalstudyPrimaryendpointPrimaryvariablePrincipleinvestigator PIProductlicensePLProtocolProtocolAmendmentsQualityassuranceQAQualityassuranceunitQAUQualitycontrolQC

中文全稱新化學(xué)實(shí)體新藥申請核磁共振譜非臨床研究非劣效性非參數(shù)統(tǒng)計(jì)方法依從性旋光光譜非盲隨意滴定原始醫(yī)療記錄結(jié)果結(jié)果評(píng)價(jià)結(jié)果指標(biāo)評(píng)價(jià)結(jié)果指標(biāo)離群值平行組設(shè)計(jì)參數(shù)估計(jì)參數(shù)統(tǒng)計(jì)方法病人檔案病歷符合方案集安慰劑安慰劑對(duì)照多分類檢驗(yàn)效能精密度臨床前研究主要終點(diǎn)主要變量主要研究者產(chǎn)品許可證試驗(yàn)方案修正案質(zhì)量保證質(zhì)量保證部門質(zhì)量控制英文全稱Querylist queryformRandomizationRangecheckRatingscaleReferenceProductRegulatoryauthorities RAReplicationRSDRuninSafetyevaluationSafetysetSamplesizeScaleoforderedcategoricalratingsSecondaryvariableSequenceSeriousadverseeventSAESeriousadversereactionSARSeriousnessSeveritySeveritySignificantlevelSimpleRandomizationSingleblindingSiteauditSOPSourcedataSDSourcedataverificationSDVSourcedocumentSDSpecificitySponsorSponsor-investigatorStandardcurveStandardoperatingprocedureSOPStatisticStatisticalanalysisplanStatisticalmodelStatisticaltables

中文全稱應(yīng)用疑問表隨機(jī)范圍檢查量表參比制劑監(jiān)督管理部門可重復(fù)日內(nèi)和日間相對(duì)標(biāo)準(zhǔn)差準(zhǔn)備期安全性評(píng)價(jià)安全性評(píng)價(jià)的數(shù)據(jù)集樣本量樣本大小有序分類指標(biāo)次要變量試驗(yàn)次序嚴(yán)重不良事件嚴(yán)重不良反應(yīng)嚴(yán)重性嚴(yán)重程度嚴(yán)重程度檢驗(yàn)水準(zhǔn)簡單隨機(jī)單盲試驗(yàn)機(jī)構(gòu)稽查試驗(yàn)室的標(biāo)準(zhǔn)操作規(guī)程原始數(shù)據(jù)原始數(shù)據(jù)核準(zhǔn)原始文件特異性申辦者申辦研究者標(biāo)準(zhǔn)曲線標(biāo)準(zhǔn)操作規(guī)程統(tǒng)計(jì)量統(tǒng)計(jì)分析計(jì)劃統(tǒng)計(jì)模型統(tǒng)計(jì)分析表英文全稱StratifiedStudyAuditStudyauditStudySiteSubgroupSub-investigatorSubjectSubjectSubjectdiarySubjectEnrollmentSubjectenrollmentlogSubjectidentificationcodeSICSubjectIdentificationCodeListSubjectRecruitmentSubjectscreeninglogSuperioritySurvivalanalysisSXRDSystemauditSystemAuditT1/2TargetvariableT－BILT－CHOTestProductTGTLC、HPLCTmaxTPTransformationTreatmentgroupTrialerrorTrialInitialMeetingTrialMasterFileTrialobjectiveTrialsiteTripleblinding

中文全稱分層研究稽查研究稽查研究中心亞組助理研究者受試者受試者受試者日記受試者入選受試者入選表受試者識(shí)別代碼受試者識(shí)別代碼表受試者招募受試者篩選表檢驗(yàn)生存分析單晶X－射線衍射系統(tǒng)稽查系統(tǒng)稽查消除半衰期目標(biāo)變量總膽紅素總膽固醇受試制劑熱重分析制備色譜峰時(shí)間總蛋白變量變換試驗(yàn)組試驗(yàn)誤差試驗(yàn)啟動(dòng)會(huì)議試驗(yàn)總檔案試驗(yàn)?zāi)康脑囼?yàn)場所三盲英文全稱中文全稱Twoone-sidetest雙單側(cè)檢驗(yàn)Un-blinding揭盲UnexpectedadverseeventUAE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MCHCmeancorpuscularhemoglobin平均紅細(xì)胞血紅蛋白濃度concerntrationRDWredbloodcellvolumedistributionwidth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)英文全稱生化檢驗(yàn)TBtotalbilirubinDBdirectbilirubinTPtotalproteinALBalbuminGLOBglobulinUREAureaCREAcreatinineUAuricacidGLUglucoseALTalanineamiotransferaseASTaspartateaminotransferaseGGTγ-glutamyltranspeptadaseCKcreatinekinaseCK-MBcreatinekinase-MBLDHlactatedehydrogenase-HBDα-hydroxybutyricdehydrogenaseAMYserumamylaseTGtriglycerideCHOLcholesterolHDL-chigh-densitylipoproteincholesterolLDL-clow-densitylipoproteincholesterolVLDLverylow-densitylipoproteinCaserumcalciumMgserummagnesiumIPinorganicphosphate