臨床研究縮寫(xiě)

1、縮略語(yǔ)ADE ADRAEAI BMI CI COI CRC CRF CRO CSA CTA CTX CTP CTR DSMB英文全稱(chēng)Adverse Drug Event Adverse Drug Reaction Adverse Event Assistant Investigator Body Mass IndexCo-investigator Coordinating InvestigatorClinical Research Coordinator Case Report FormContract Research Organization Clinical Study Applicat

2、ion Clinical Trial ApplicationClinical Trial Exemption Clinical Trial Protocol Clinical Trial ReportData Safety and Monitoring Board中文全稱(chēng)不良事件體質(zhì)指數(shù) 病歷報(bào)告表合同研究組織臨床研究申請(qǐng)臨床試驗(yàn)申請(qǐng)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)EDC EDP FDA FR GCPElectronic Data Capture Electronic Data Processing Food and Drug Administration Final

3、ReportGood Clinical Practice電子數(shù)據(jù)采集系統(tǒng)電子數(shù)據(jù)處理系統(tǒng)美國(guó)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GLPGood LaboratoryPractice藥物非臨床試驗(yàn)質(zhì)量管理規(guī)范GMP IBIC ICF ICHGood Manufacturing Practice Investigators Brochure Informed ConsentInformed Consent FormInternational Conference on Harmonization研究者手冊(cè)知情同意 國(guó)際協(xié)調(diào)會(huì)議IDM IDMCIndependent Data Monit

4、oringIndependent Data Monitoring Committee獨(dú)立數(shù)據(jù)監(jiān)察獨(dú)立數(shù)據(jù)監(jiān)察委員會(huì)IEC INDIndependent Ethics Committee Investigational New Drug獨(dú)立倫理委員會(huì)新藥臨床研究IRB IVD IVRSInstitutional Review BoardIn Vitro DiagnosticInteractive Voice Response System機(jī)構(gòu)審查委員會(huì)體外診斷互動(dòng)語(yǔ)音應(yīng)答系統(tǒng)MA MCA MHW NDA NEC NIH PIPLPMA PSIMarketing Approval/Authoriz

5、ation Medicines Control Agency Ministry of Health and Welfare New Drug ApplicationNew Drug EntityNational Institutes of HealthPrincipal Investigator Product License英文全稱(chēng)Pre-market Approval（Application）Statisticians in the Pharmaceutical Industry上市許可證英國(guó)藥品監(jiān)督局日本衛(wèi)生福利部新藥申請(qǐng)新化學(xué)實(shí)體國(guó)家衛(wèi)生研究所（美國(guó)主要研究者產(chǎn)品許可證中文全稱(chēng)上市前許

6、可（申請(qǐng)） 制藥業(yè)統(tǒng)計(jì)學(xué)家協(xié)會(huì)QAQualityAssurance質(zhì)量保證QC RA SA SAE SAP SAR SD SD SFDAQuality Control Regulatory Authorities Site Assessment Serious Adverse Event Statistical Analysis PlanSerious Adverse Reaction Source Data/Document Subject DiaryState Food and DrugAdministration質(zhì)量控制現(xiàn)場(chǎng)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

7、國(guó)家食品藥品監(jiān)督管理局SDV SEL SI SI SIC SOPSource Data Verification Subject Enrollment Log Sub-investigator Sponsor-InvestigatorSubject Identification Code Standard Operating Procedure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SPLSPLStudy 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UAEUn

8、expected Adverse Event預(yù)料外不良事件WHOWorld Health Organization世界衛(wèi)生組織WHO-ICDRWHO International Conference ofADrug Regulatory AuthoritiesWHO 國(guó)際藥品管理當(dāng)局會(huì)議藥物臨床試驗(yàn)英文縮寫(xiě)英文全稱(chēng)英文全稱(chēng)中文全稱(chēng)Accuracy準(zhǔn)確度Active control，AC陽(yáng)性對(duì)照 活性對(duì)照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 Lethal Dose）近似致死劑量ALP堿性磷酸

9、酶Alpha spending function消耗函數(shù)ALTAnalysis sets ApprovalAssistantinvestigator ASTATRAuditAudit or inspection Audit report AuditorBias Bioequivalence Blank control Blind codes Blind review丙氨酸氨基轉(zhuǎn)移酶統(tǒng)計(jì)分析的數(shù)據(jù)集批準(zhǔn)助理研究者天門(mén)冬酸氨基轉(zhuǎn)移酶衰竭全反射法穩(wěn)態(tài)血藥濃度-時(shí)間曲線下面積稽查稽查/視察稽查報(bào)告稽查員偏性 偏倚空白對(duì)照 編制盲底盲態(tài)審核/盲法檢查Blinding method BlockBlock

10、size Carryover effect Case historyCase report form/case record form CRF Categorical variableCav CD CLClincal equivalence Clinical study Clinical study reportClinical trial application CTA Clinical trial/study report盲法盲法/設(shè)盲層延滯效應(yīng) 病歷病例報(bào)告表/病例記錄表分類(lèi)變量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)申請(qǐng)臨床試驗(yàn)報(bào)告Cmax Comparison Complia

11、nceCompositevariableComputer-assisted trial design，CATD ConfidenceintervalConfidence level Consistency test Contract/agreement Control group Coordinating committee CreaCrossover designCross-over study CssCure峰濃度對(duì) 照 依從性復(fù)合變量可信區(qū)間置信水平 協(xié)議/合同對(duì)照組肌酐穩(wěn) 濃 度 痊愈Data management DatabaseDescriptive statistical ana

12、lysis DFDichotomies Diviation Dose-reaction relation DoubledummyDouble dummy technique Drop outDSCEffectivenessElectronic data capture EDC Electronic data processing EDP Emergency envelope數(shù)據(jù)管理 描述性統(tǒng)計(jì)分析波動(dòng)系統(tǒng)二分類(lèi)偏差記錄/文件劑量-反應(yīng)關(guān)系雙模擬脫落療效電子數(shù)據(jù)采集系統(tǒng)電子數(shù)據(jù)處理系統(tǒng)應(yīng)急信件End pointEndpoint criteria/measurement EquivalenceEs

13、sential documentation Ethics committee ExcellentExclusion criteria Factorial design FailureFinal pointFixed-dose procedure Forced titrationFull analysis set GC-FTIRGC-MSGeneric drug終點(diǎn)終點(diǎn)指標(biāo)等 效 性 必須文件顯效排除標(biāo)準(zhǔn)析因設(shè)計(jì)終點(diǎn)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)譜連用通用名藥Global assessmentvariable GLUGood non-clincal laboratory

14、practice， GLPGroup sequential designHealth economic evaluation，HEV Hypothesis testHypothesis testing Improvement Inclusion criteriaIndependent ethic committee， IEC Information consent form， ICF Information gatheringInitial meeting Inspection Institutioninspection全局評(píng)價(jià)變量血糖藥物非臨床研究質(zhì)量管理規(guī)范成組序貫設(shè)計(jì) 假設(shè)檢驗(yàn)假設(shè)檢驗(yàn)好

15、轉(zhuǎn)入選標(biāo)準(zhǔn)獨(dú)立倫理委員會(huì)知情同意書(shū)視察/機(jī)構(gòu)檢查Institution review board， IBR Intention-to-treat，ITTInteractive voice response system， IVRSInterim analysisInternational conference of harmonization, ICHInvestigational productLast observation carry forward，LOCF LC-MSLD50Logic checkLOQ（limit of quantization） Lost of follow up

16、Marketing approval/authorization Matched pairMissing value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(yǔ)音應(yīng)答系統(tǒng)期中分析人用藥品注冊(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)議試驗(yàn)藥物最近一次觀察的結(jié)轉(zhuǎn)液相色譜-質(zhì)譜聯(lián)用半數(shù)致死劑量邏輯檢查定 量 限 失訪匹配配對(duì) 缺失值Mixed effect model MonitorMonitoring Monitoring plan MRTMSMS-MSMTD（Maximum tolerated dose） Multi-center trialNMRNon-clinical study Non-inf

17、eriorityNon-parametric statistics ObedienceODROpen-label混合效應(yīng)模式監(jiān)察員監(jiān)查監(jiān)察計(jì)劃平均滯留時(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)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Optional titration Original medical record OutcomeOutcome assessment Outcome measurement OutlierParallel group design Parameter estimation Parametric statistics Patient file

18、Patient history Per protocol，PP PlaceboPlacebo control Polytomies Power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)離群值參數(shù)估計(jì)病人檔案病歷安慰劑多分類(lèi)檢驗(yàn)效能Precision Preclinical study Primary endpoint Primary variablePrinciple investigator，PI Product license, PL ProtocolProtocol amendments Quality assurance，QA Quality assurance unit，

19、QAU Qualitycontrol，QCQuerylistquery form RandomizationRange check Rating scale Reference product精密度主要終點(diǎn) 主要變量 試驗(yàn)方案 修正案質(zhì)量保證質(zhì)量控制隨機(jī)量表參比制劑Regulatory authorities，RA ReplicationRSDRun inSafety evaluation Safety set Sample sizeScale of ordered categorical ratings Secondary variableSequence Seriousness Sever

20、ity Significant levelSimple randomization Single blindingSite audit可重復(fù)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(lèi)指標(biāo)次要變量試驗(yàn)次序嚴(yán) 重 性 嚴(yán)重程度檢驗(yàn)水準(zhǔn)簡(jiǎn)單隨機(jī)單盲試驗(yàn)機(jī)構(gòu)稽查SOPSource data, SDSource data verification，SDV Source document，SD SpecificitySponsorSponsor-investigator Standard curveStandard operating procedure，SOP StatisticStat

21、istical analysis plan Statistical model Statistical tables StratifiedStudy audit Study site原始數(shù)據(jù)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)分析表分層研究稽查研究中心SubgroupSub-investigator SubjectSubject enrollment Subject enrollment logSubject identification code，SIC Subject identification code list Subject recrui

22、tmentSubject screening log SuperioritySXRDSystem audit T1/2Target variable T-BILT-CHO亞組助理研究者受試者受試者入選 受試者識(shí)別代碼 受試者招募受試者篩選表檢驗(yàn)X-系統(tǒng)稽查目標(biāo)變量 總膽紅素 總膽固醇Test product TGTLC、HPLCTmax TPTransformation Treatment group Trial errorTrial initialmeeting Trial master file Trial objective TrialsiteTriple blinding Two on

23、e-side test Un-blindingUnexpected adverse event，UAE峰 時(shí) 間 總 蛋 白 試 驗(yàn) 組 試驗(yàn)總檔案 試驗(yàn)?zāi)康娜そ颐ゎA(yù)料外不良事件UV-VISVariableVisual analogy scale Visual check Vulnerable subject Wash-outWashout period血常規(guī)WBC white blood cell count GR% granulocyte LY%lymphocyteMID%EOS% eosimophilAL% allergy lymphocyte ST%紫外-變異變量直觀類(lèi)比打分法人工檢查弱勢(shì)