臨床試驗(yàn)以及實(shí)驗(yàn)室中常見的中英文名詞及縮寫

1、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中文全稱ADEAdverseDrugEvent藥物不良事件ADRAdverseDrugReaction藥物不良反應(yīng)AEAdverseEvent不良事件AIAssistantInvestigator助理研究者BMIBodyMassIndex體質(zhì)指數(shù)CICo-investigator合作研究者COICoordinatingInvestigator協(xié)調(diào)研究者CRCClinicalResearchCoordinator臨床研究協(xié)調(diào)者CRFCaseReportForm病歷報(bào)告表CROContractRese

2、archOrganization合同研究組織一CSAClinicalStudyApplication臨床研究申請CTAClinicalTrialApplication臨床試驗(yàn)申請CTXClinicalTrialExemption臨床試驗(yàn)免責(zé)CTPClinicalTrialProtocol臨床試驗(yàn)方案CTRClinicalTrialReport臨床試驗(yàn)報(bào)告DSMBDataSafetyandmonitoringBoard數(shù)據(jù)安全及監(jiān)控委員會EDCElectronicDataCapture電子數(shù)據(jù)采集系統(tǒng)EDPElectronicDataProcessing電子數(shù)據(jù)處理系統(tǒng)FDAFoodandDru

3、gAdministration美國食品與藥品管理局FRFinalReport總結(jié)報(bào)告GCPGoodClinicalPractice藥物臨床試驗(yàn)質(zhì)量管理規(guī)范GCPGoodLaboratoryPractice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IBInvestigator ' sBrochure研究者手冊ICInformedConsent知情同意ICFInformedConsentForm知情同意書ICHInternationalConferenceonHarmonization國際協(xié)調(diào)會議IDMIndependentDat

4、aMonitoring獨(dú)立數(shù)據(jù)監(jiān)察IDMCIndependentDataMonitoringCommittee獨(dú)立數(shù)據(jù)監(jiān)察委員會IECIndependentEthicsCommittee獨(dú)立倫理委員會INDInvestigationalNewDrug新藥臨床研究IRBInstitutionalReviewBoard機(jī)構(gòu)審查委員會IVDInVitroDiagnostic體外診斷IVRSInteractiveVoiceResponseSystem互動語音應(yīng)答系統(tǒng)MAMarketingApproval/Authorization上市許可證MCAMedicinesControlAgency英國藥品監(jiān)督

5、局MHWMinistryofHealthandWelfare日本衛(wèi)生福利部NDANewDrugApplication新藥申請NECNewDrugEntity新化學(xué)實(shí)體NIHNationalInstitutesofHealth國家衛(wèi)生研究所（美國）縮略語英文全稱中文全稱PIPrincipalInvestigator主要研究者PLProductLicense產(chǎn)品許可證PMAPre-marketApproval(Application)上市前許可（申請）PSIStatisticiansinthePharmaceuticalIndustry制藥業(yè)統(tǒng)計(jì)學(xué)家協(xié)會QAQualityAssurance呆證QC

6、QualityControl質(zhì)量控制RARegulatoryAuthorities監(jiān)督管理部門SASiteAssessment現(xiàn)場評估SAESeriousAdverseEvent嚴(yán)重不良事件SAPStatisticalAnalysisPlan統(tǒng)計(jì)分析計(jì)劃SARSeriousAdverseReaction嚴(yán)重不良反應(yīng)SDSourceData/Document原始數(shù)據(jù)/文件SDSubjectDiary受試者日記.SFDAStateFoodandDrugAdministration國家食品藥品監(jiān)督管理局SDVSourceDataVerification原始數(shù)據(jù)核準(zhǔn)SELSubjectEnrollme

7、ntLog受試后選表SISub-investigator助理研究者SISponsor-Investigator申辦研究者SICSubjectIdentificationCode受試者識別代碼SOPStandardOperatingProcedure標(biāo)準(zhǔn)操作規(guī)程SPLStudyPersonnelList研究人員名單SSLSubjectScreeningLog受試者篩選表T&RTestandReferenceProduct受試和參比試劑UAEUnexpectedAdverseEvent預(yù)料外不良事件WHOWorldHealthOrganization世界衛(wèi)生組織WHO-ICDRAWHOIn

8、ternationalConferenceofDrugRegulatoryAuthoritiesWHO國際藥品管理當(dāng)局會議藥物臨床試驗(yàn)英文縮寫英文全稱中文全稱Accuracy準(zhǔn)確度Activecontrol,AC陽性對照活性對照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 )近似致夕匕劑量ALP堿性磷酸酶Alphaspendingfunction消耗函數(shù)ALT丙氨酸氨基轉(zhuǎn)換酶Analys

9、issets統(tǒng)計(jì)分析的數(shù)據(jù)集,二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)血藥濃度一時間曲線卜面積Audit稽查Auditorinspection稽查/視察Auditreport稽查報(bào)告Auditor航員Bias偏性偏倚Bioequivalence生物等效應(yīng)Blankcontrol空白對照Blindcodes編制自底Blindreview百態(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Carryoveref

10、fect延滯效應(yīng)Casehistory病歷Casereportform/caserecordformCRF病例報(bào)告表病例記錄表Categoricalvariable分類及重英乂全稱中乂全稱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)ClinicaltrialapplicationCTA臨床試驗(yàn)申請ClinicaltrialexemptionCTX臨床試驗(yàn)免責(zé)-1ClinicaltrialprotocolCTP臨床試驗(yàn)方案、1Clin

11、icaltrial/studyreport臨床試驗(yàn)報(bào)告Cmax峰濃度1Co-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)ContractresearchorganizationCRO合同研究組織Contract/agreement協(xié)議/合同Controlgroup對照組Coordinatingcommittee協(xié)

12、調(diào)委員會Crea1：一肌酎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波動系統(tǒng)Dichotomies二分類DiviationBitDocumentation記錄/文件英乂全稱中乂全稱Dose-reactionrelation劑量-反應(yīng)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

13、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)

14、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- MS1 .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)

15、Healtheconomicevaluation,HEV健康經(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入選表準(zhǔn)英乂全稱中乂全稱Inclusioncriteria入選標(biāo)準(zhǔn)Independentethicscommittee IEC獨(dú)立倫理委員會Informationconsentform ICF知情同意書InformationGathering信息收集InformedconsentIC知情同意Initialmeeting啟動會議Inspection檢察/視察Institutioninspec

16、tion機(jī)構(gòu)檢查Institutionreviewboard,IBR機(jī)構(gòu)審查委員會Intention-to 七eatITT意向性分析（一統(tǒng)計(jì)學(xué)）,Interactivevoiceresponsesystem IVRS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)會議二；二. 1 11InvestigationalProduct試驗(yàn)藥物F _.Investigator研究者Investigator ' sbrochure,IB研究者手冊Lastobser

17、vationcarryforward,LOCF最接次觀察的結(jié)轉(zhuǎn)LC MS液相色譜-質(zhì)譜聯(lián)用LD50板數(shù)致夕匕劑量LOCF,Lastobservationcarryforward最次觀察的結(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Mixedeffectmodel混合效應(yīng)模式Monitor監(jiān)察員Monitoring監(jiān)查MonitoringPlan監(jiān)察計(jì)劃MonitoringReport

18、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 (MaximumToleratedDose )取大耐受劑里Multi-centerTrial多中心試驗(yàn)英乂全稱中乂全稱Newchemicalentity NCE新化學(xué)實(shí)體Newdrugapplication NDA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1Optionaltitration隨意滴定,1Originalmedicalrecord

19、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Perprotocol PP符合方案集Placebo安慰劑Placebocontrol安慰劑對照Polytomies多分類Power檢驗(yàn)效能Precision精密度Preclinicalstudy臨床前研究P

20、rimaryendpoint主要終點(diǎn)Primaryvariable主要變量Principleinvestigator PI主要研究者ProductlicensePL產(chǎn)品許可證Protocol試驗(yàn)方案ProtocolAmendments修正案QualityassuranceQA»保證QualityassuranceunitQAU質(zhì)量保證部門QualitycontrolQC叫控制英乂全稱中乂全稱Querylist queryform應(yīng)用疑問表Randomization隨機(jī)Rangecheck范圍檢查Ratingscale里表ReferenceProduct參比制劑Regulatoryau

21、thorities RA監(jiān)督管理部門Replication可重復(fù)RSD日內(nèi)和日間相對標(biāo)準(zhǔn)差Runin準(zhǔn)備期-1Safetyevaluation安全性評價,1Safetyset安全性評價的數(shù)據(jù)集Samplesize樣本重樣本大小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)重不良反應(yīng)Seriousness嚴(yán)重性Severity嚴(yán)重程度Severity嚴(yán)重程度Significantlevel檢驗(yàn)水

22、準(zhǔn)SimpleRandomization簡單隨機(jī)Singleblinding單自Siteaudit試驗(yàn)機(jī)構(gòu)稽查sop_ r-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Standardoperatingprocedure SOP標(biāo)準(zhǔn)操作規(guī)程Statistic統(tǒng)計(jì)1Statisticalanalysisplan統(tǒng)計(jì)分析計(jì)劃Statisticalmodel統(tǒng)計(jì)

23、模型Statisticaltables統(tǒng)計(jì)分析表英乂全稱中乂全稱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受試后入選表Subjectidentificationcode SIC受試者識別代碼SubjectIdentificationCodeList受試者識別代碼表SubjectRecruitment受試者招募Sub

24、jectscreeninglog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Tmax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?/p>

25、Trialsite試驗(yàn)場所Tripleblinding二盲英文全稱中文全稱Twoone-sidetest雙單側(cè)檢驗(yàn)Un-blinding揭盲Unexpectedadverseevent UAE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

26、%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MCHCmeancorpuscularhemoglobinconcerntrati on平均紅細(xì)胞血紅蛋白濃度11i r,RDWredbloodceHvol

27、umedistributionwidth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ad

28、dish 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)英文全稱中文全稱生化檢驗(yàn)TBtotalbilirubin總膽紅素DBdirectbilirubin直接膽紅素TPtotalprotein總蛋白ALBalbumin白蛋白GLOBglobulin球蛋白UREAureaCREAcreatinine肌肝UAuricacid尿酸GLUglucose血糖.ALTalanineamiotra

29、nsferase丙氨酸氨基轉(zhuǎn)移酶ASTaspartateaminotransferase口冬氨酸氨基轉(zhuǎn)移酶GGT 丫 -glutamyltranspeptadase谷氨酰轉(zhuǎn)肽酶' .CKcreatinekinase肌酸肌酶1" 1CK-MBcreatinekinase-MB肌酸肌酶同工酶LDHlactatedehydrogenase乳酸脫氫酶a -HBD a -hydroxybutyricdehydrogenasea -羥丁酸脫氫酶AMYserumamylase血淀粉酶TGtriglyceride肝油三脂CHOLcholesterol膽固醇HDL-chigh-densitylipoproteincholesterol高密度