臨床試驗以及實驗室中常見的中英文名詞及縮寫

1、中國創(chuàng)新藥咨詢與服務先鋒CRO臨床試驗以及實驗室中常見的英文縮寫藥物臨床試驗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AEAdverseEvent不良事件AIAssistantInvestigator助理研究者BMIBodyMassIndex體質指數(shù)CICo-investigator合作研究者COICoordinatingInvestigator協(xié)調研究者CRCClinicalResearchCoordinator臨床研究協(xié)調者CRFCaseReportForm病歷報告表CROContractRese

2、archOrganization合同研究組織一CSAClinicalStudyApplication臨床研究申請CTAClinicalTrialApplication臨床試驗申請CTXClinicalTrialExemption臨床試驗免責CTPClinicalTrialProtocol臨床試驗方案CTRClinicalTrialReport臨床試驗報告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總結報告GCPGoodClinicalPractice藥物臨床試驗質量管理規(guī)范GCPGoodLaboratoryPractice藥物非臨床試驗質量管理規(guī)范GMPGoodManufacturingPractice藥品生產質量管理規(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)調會議IDMIndependentDat

4、aMonitoring獨立數(shù)據(jù)監(jiān)察IDMCIndependentDataMonitoringCommittee獨立數(shù)據(jù)監(jiān)察委員會IECIndependentEthicsCommittee獨立倫理委員會INDInvestigationalNewDrug新藥臨床研究IRBInstitutionalReviewBoard機構審查委員會IVDInVitroDiagnostic體外診斷IVRSInteractiveVoiceResponseSystem互動語音應答系統(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新化學實體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產品許可證PMAPre-marketApproval(Application)上市前許可（申請）PSIStatisticiansinthePharmaceuticalIndustry制藥業(yè)統(tǒng)計學家協(xié)會QAQualityAssurance呆證QC

6、QualityControl質量控制RARegulatoryAuthorities監(jiān)督管理部門SASiteAssessment現(xiàn)場評估SAESeriousAdverseEvent嚴重不良事件SAPStatisticalAnalysisPlan統(tǒng)計分析計劃SARSeriousAdverseReaction嚴重不良反應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標準操作規(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國際藥品管理當局會議藥物臨床試驗英文縮寫英文全稱中文全稱Accuracy準確度Activecontrol,AC陽性對照活性對照Adversedrugreaction,ADR藥物不良反應Adverseevent,AE不良事件Adversemedicalevents不良醫(yī)學事件Adversereaction藥物不良反應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丙氨酸氨基轉換酶Analys

9、issets統(tǒng)計分析的數(shù)據(jù)集,二Approval批準Assistantinvestigator助理研究者AST天門冬酸氨基轉換酶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稽查報告Auditor航員Bias偏性偏倚Bioequivalence生物等效應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/設盲Block層Blocksize每段的長度Carryoveref

10、fect延滯效應Casehistory病歷Casereportform/caserecordformCRF病例報告表病例記錄表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Clinicalstudy臨床研究Clinicalstudyreport臨床試驗的總結報告Clinicaltrial臨床試驗ClinicaltrialapplicationCTA臨床試驗申請ClinicaltrialexemptionCTX臨床試驗免責-1ClinicaltrialprotocolCTP臨床試驗方案、1Clin

11、icaltrial/studyreport臨床試驗報告Cmax峰濃度1Co-investigator合作研究者Comparison對照Compliance依從性Compositevariable復合變量Computer-assistedtrialdesignCATD計算機輔助試驗設計Confidenceinterval可信區(qū)間Confidencelevel置信水平Consistencytest一致性檢驗ContractresearchorganizationCRO合同研究組織Contract/agreement協(xié)議/合同Controlgroup對照組Coordinatingcommittee協(xié)

12、調委員會Crea1：一肌酎CRF(casereportform)病例報告表Crossoverdesign交叉設計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-反應關系Doubledummy雙模擬Doubledummytechnique雙盲雙模擬技術Dropout脫落DSC差示掃描熱量

13、計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應急信件Endpoint終點EndpointCriteria終點指標Endpointcriteria/measurement終點指標Equivalence等效性EssentialDocumentation必需文件Ethicscommittee倫理委員會Excellent顯效Exclusioncriteria排除標準Factorialdesign析因設計Failure無效失敗Finalpoint終點

14、Fixed-doseprocedure固定劑量法Forcedtitration強制滴定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藥物臨床試驗質量管理規(guī)范Goodmanufacturepractice,GMP藥品生產質量管理規(guī)范Goodnon-clinicallaboratorypractice,GLP藥物非臨床研究質量管理規(guī)范Groupsequentialdesign成組序貫設計

15、Healtheconomicevaluation,HEV健康經濟學評價Hypothesistest假設檢驗Hypothesistesting假設檢驗Improvement好轉InclusionCriteria入選表準英乂全稱中乂全稱Inclusioncriteria入選標準Independentethicscommittee IEC獨立倫理委員會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機構檢查Institutionreviewboard,IBR機構審查委員會Intention-to 七eatITT意向性分析（一統(tǒng)計學）,Interactivevoiceresponsesystem IVRS互動式語音應答系統(tǒng)Interimanalysis期中分析：InternationalConferenceofHarmonizationICH人用藥品注冊技術要求國際技術協(xié)調會國際協(xié)調會議二；二. 1 11InvestigationalProduct試驗藥物F _.Investigator研究者Investigator ' sbrochure,IB研究者手冊Lastobser

17、vationcarryforward,LOCF最接次觀察的結轉LC MS液相色譜-質譜聯(lián)用LD50板數(shù)致夕匕劑量LOCF,Lastobservationcarryforward最次觀察的結轉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混合效應模式Monitor監(jiān)察員Monitoring監(jiān)查MonitoringPlan監(jiān)察計劃MonitoringReport

18、監(jiān)察報告MRT平均滯留時間MS質譜MS-MS質譜-質譜聯(lián)用MTD (MaximumToleratedDose )取大耐受劑里Multi-centerTrial多中心試驗英乂全稱中乂全稱Newchemicalentity NCE新化學實體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)計方法Obedience依從性ODR旋光光譜Open-label非盲1Optionaltitration隨意滴定,1Originalmedicalrecord

19、原始醫(yī)療記錄Outcome結果OutcomeAssessment結果評價-Outcomeassessment結果指標評價Outcomemeasurement結果指標Outlier離群值Parallelgroupdesign平行組設計Parameterestimation參數(shù)估計Parametricstatistics參數(shù)統(tǒng)計方法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檢驗效能Precision精密度Preclinicalstudy臨床前研究P

20、rimaryendpoint主要終點Primaryvariable主要變量Principleinvestigator PI主要研究者ProductlicensePL產品許可證Protocol試驗方案ProtocolAmendments修正案QualityassuranceQA»保證QualityassuranceunitQAU質量保證部門QualitycontrolQC叫控制英乂全稱中乂全稱Querylist queryform應用疑問表Randomization隨機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RSD日內和日間相對標準差Runin準備期-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Secondaryvariable次要變量Sequence試驗次序SeriousadverseeventSAE嚴重不良事件SeriousadversereactionSAR嚴重不良反應Seriousness嚴重性Severity嚴重程度Severity嚴重程度Significantlevel檢驗水

22、準SimpleRandomization簡單隨機Singleblinding單自Siteaudit試驗機構稽查sop_ r-試驗室的標準操作規(guī)程SourcedataSD原始數(shù)據(jù)SourcedataverificationSDV原始數(shù)據(jù)核準SourcedocumentSD原始文件Specificity特異性Sponsor申辦者Sponsor-investigator申辦研究者Standardcurve標準曲線Standardoperatingprocedure SOP標準操作規(guī)程Statistic統(tǒng)計1Statisticalanalysisplan統(tǒng)計分析計劃Statisticalmodel統(tǒng)計

23、模型Statisticaltables統(tǒng)計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試驗組Trialerror試驗誤差TrialInitialMeeting試驗啟動會議TrialMasterFile試驗總檔案Trialobjective試驗目的

25、Trialsite試驗場所Tripleblinding二盲英文全稱中文全稱Twoone-sidetest雙單側檢驗Un-blinding揭盲Unexpectedadverseevent UAE預料外不良事件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洗脫期實驗室檢查英文縮寫英文全稱中文全稱血常規(guī)WBCwhitebloodcellcount白細胞計數(shù)GR%granulocyte中性粒細胞百分比LY

26、%lymphocyte淋巴細胞百分比MID%中值細胞百分比EOS%eosimophil嗜酸性粒細胞百分比AL%allergylymphocyte變異淋巴細胞百分比ST%中性桿狀粒細胞百分比RBCredbloodcell紅細胞計數(shù)HGBhemoglobin血紅蛋白HCThematocrit紅細胞比積紅細胞比積MCVmeancorpusularvolume平均紅細胞體積MCHmeancorpusularhemoglobin平均紅細胞血紅蛋白含量MCHCmeancorpuscularhemoglobinconcerntrati on平均紅細胞血紅蛋白濃度11i r,RDWredbloodceHvol

27、umedistributionwidth紅細胞分布寬度變異PLT/BPCplateletcount/bloodplateletcount血小板計數(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白細胞ad

28、dish 計數(shù) addishcount艾迪氏計數(shù)/HPhighpowerobjective每高倍視野/LPlowpowerobjective每低倍視野OBoccultbloodtest大便隱血試驗體液常規(guī)CSFcerebrospinal腦積夜Pandypandy龐氏試驗英文全稱中文全稱生化檢驗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丙氨酸氨基轉移酶ASTaspartateaminotransferase口冬氨酸氨基轉移酶GGT 丫 -glutamyltranspeptadase谷氨酰轉肽酶' .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