临床研究缩写

1、临床研究缩写临床研究缩写 PAGE PAGE 18 / 18缩略语ADE ADR AE AI BMI CI COI CRC CRF CRO CSA CTA CTX CTP CTRDSMB EDC EDP FDA FR GCP英文全称Adverse Drug Event Adverse Drug Reaction Adverse Event Assistant Investigator Body Mass IndexCo-investigator Coordinating InvestigatorClinical Research Coordinator Case Report FormCont

2、ract Research Organization Clinical Study Application Clinical Trial ApplicationClinical Trial Exemption Clinical Trial Protocol Clinical Trial ReportData Safety and Monitoring Board Electronic Data CaptureElectronic Data Processing Food and Drug Administration Final ReportGood Clinical Practice中文全称

3、不良事件体质指数 病历报告表合同研究组织临床研究申请临床试验申请临床试验免责临床试验方案临床试验报告电子数据采集系统电子数据处理系统美国食品与药品管理局总结报告药物临床试验质量管理规范GLP GMP IBIC ICFGood Laboratory Practice Good Manufacturing Practice Investigators Brochure Informed ConsentInformed Consent Form药物非临床试验质量管理规范药物生产质量管理规范知情同意 ICHInternationalConference国际协调会议IDMHarmonizationInd

4、ependent Data Monitoring独立数据监察IDMCIndependentData独立数据监察委员会IEC IND IRB IVD IVRS MA MCA MHW NDA NEC NIH PICommitteeIndependent Ethics Committee Investigational New Drug Institutional Review BoardIn Vitro DiagnosticInteractive Voice Response System Marketing Approval/Authorization Medicines Control Age

5、ncy Ministry of Health and Welfare New Drug ApplicationNew Drug EntityNational Institutes of Health Principal Investigator新药临床研究 体外诊断互动语音应答系统上市许可证英国药品监督局日本卫生福利部新药申请新化学实体国家卫生研究所（美国主要研究者PL缩略语PMA PSIQA QC RA SA SAE SAP SAR SD SD SFDA SDV SEL SISI SIC SOP SPLProduct License英文全称Pre-market Statisticiansin

6、theIndustryQuality Assurance Quality Control Regulatory Authorities Site Assessment Serious Adverse Event Statistical Analysis PlanSerious Adverse Reaction Source Data/Document Subject DiaryState Food and Drug Administration Source Data VerificationSubject Enrollment Log Sub-investigator Sponsor-Inv

7、estigatorSubject Identification Code Standard Operating Procedure Study Personnel List产品许可证中文全称上市前许可（申请） 制药业统计学家协会现场评估严重不良事件统计分析计划严重不良反应原始数据/文件受试者日记国家食品药品监督管理局原始数据核准助理研究者 申办研究者标准操作规程 研究人员名单SSLSSLSubject Screening Log受试者筛选表T&RTest and Reference Product受试和参比试剂UAEUnexpected Adverse Event预料外不良事件WHOWorld

8、 Health Organization世界卫生组织WHO-ICDRAWHOInternationalConferenceofWHO 国际药品管理当局会议Drug Regulatory Authorities药物临床试验英文缩写英文全称AccuracyActive control，AC Adverse medical events Adverse reactionAlbALD（Approximate Lethal ALPAlpha spending function ALTAnalysis sets ApprovalAssistant investigatorAST中文全称准确度阳性对照 活性

9、对照不良医学事件药物不良反应白蛋白碱性磷酸酶 消耗函数丙氨酸氨基转移酶统计分析的数据集批准助理研究者天门冬酸氨基转移酶ATRAUCss AuditAudit or inspection Audit report AuditorBias Bioequivalence Blank control Blind codes Blind review Blinding Blinding/masking BlockBlock size Carryover effect Case historyCase report form/case record form CRF Categorical variabl

10、eCav CDCL衰竭全反射法稳态血药浓度-时间曲线下面积稽查/稽查报告稽 查 员 偏性 偏倚空白对照 编制盲底盲态审核/盲法检查盲法盲法/设盲层延滞效应 病历病例报告表/病例记录表分类变量平均浓度圆二色谱清除率Clincal equivalence Clinical study Clinical study reportClinical trial application CTA Clinical trial/study report CmaxComparison Compliance Composite variableComputer-assisted trial Confidence

11、intervalConfidence level Consistency test Contract/agreement Control group Coordinating committee CreaCrossover design Cross-over study CssCureData management临床等效应临床研究临床试验的总结报告临床试验申请峰浓度对 照 复合变量可信区间置信水平 协议/合同对照组肌酐稳 浓 度 痊愈数据管理DatabaseDescriptive statistical analysis DFDichotomies Diviation Dose-reacti

12、on relation Double dummyDouble dummy technique Drop outDSCEffectivenessElectronic data capture EDC Electronic data processing EDP Emergency envelopeEnd pointEndpoint criteria/measurement EquivalenceEssential documentation Ethics committee ExcellentExclusion criteria建立数据库描述性统计分析波动系统二分类偏差记录/文件剂量-反应关系双

13、模拟脱落疗效电子数据采集系统电子数据处理系统应急信件终点终点指标等 效 性 必须文件伦理委员会显效排除标准Factorial design FailureFinal pointFixed-dose procedure Forced titrationFull analysis set GC-FTIRGC-MSGeneric drugGlobal assessment variable GLUGood non-clincal laboratory practice，GLP Group sequential designHealth economic evaluation，HEV Hypothes

14、is testHypothesis testing Improvement Inclusion criteriaIndependent ethic committee， IEC Information consent form， ICF Information gatheringInitial meeting析因设计无效 失败终点强制滴定 全分析集气相色谱-傅利叶红外联用气相色谱-质谱连用通用名药全局评价变量血糖药物非临床研究质量管理规范成组序贯设计健康经济学评价假设检验假设检验好转入选标准独立伦理委员会知情同意书信息收集启动会议Inspection Institution inspectio

15、nInstitution review board， IBR Intention-to-treat，ITTInteractive voice response system， IVRS Interim analysisInternational conference of harmonization, ICHInvestigational productLast observation carry forward，LOCF LC-MSLD50Logic checkLOQ（limit of quantization） Lost of follow upMarketing approval/aut

16、horization Matched pairMissing value Mixed effect model Monitor MonitoringMonitoring plan视察/检查机构检查机构审查委员会意向性分析（-统计学） 互动式语音应答系统期中分析人用药品注册技术要求国际技术协调会国际协调会议试验药物最近一次观察的结转液相色谱-质谱联用半数致死剂量逻辑检查定 量 限 失访匹配配对 缺失值监察员监查监察计划MRT MSMS-MSMTD（Maximum tolerated dose） Multi-center trialNMRNon-clinical study Non-inferio

17、rityNon-parametric statistics ObedienceODROpen-label Optional titrationOriginal medical record OutcomeOutcome assessment Outcome measurement OutlierParallel group design Parameter estimation Parametric statisticsPatient file平均滞留时间质谱质谱-质谱联用最大耐受剂量多中心试验核磁共振谱非临床研究非劣效性非参数统计方法依从性旋光光谱非盲随意滴定原始医疗记录结果结果评价/结果指

18、标评价结果指标离群值参数估计病人档案Patient history Per protocol，PP PlaceboPlacebo control Polytomies Power PrecisionPreclinical study Primary endpoint Primary variablePrinciple investigator，PI Product license, PL ProtocolProtocol amendments Quality assurance，QA Quality assurance Quality Query listquery Randomization

19、Range check Rating scaleReference product病历安慰剂多分类精密度主要终点 主要变量 试验方案 修正案质量保证质量控制随机量表参比制剂Regulatory authorities，RA ReplicationRSDRun inSafety evaluation Safety set Sample sizeScale of ordered categorical ratings Secondary variableSequence Seriousness Severity Significant levelSimple randomization Singl

20、e blindingSite audit SOPSource data, SDSource data verification，SDV Source document，SD SpecificitySponsor可重复准备期安全性评价安全性评价的数据集样本量 样本大小有序分类指标次要变量试验次序严 重 性 严重程度检验水准简单随机单盲试验机构稽查原始数据原始文件特异性申办者Sponsor-investigator Standard curveStandard operating procedure，SOP StatisticStatistical analysis plan Statistica

21、l model Statistical tables StratifiedStudy audit Study site SubgroupSub-investigator SubjectSubject enrollment Subject enrollment logSubject identification code，SIC Subject identification code list Subject recruitmentSubject screening log SuperioritySXRDSystem audit申办研究者标准曲线标准操作规程统计量统计分析计划统计模型分层亚组助理

22、研究者受试者受试者入选 受试者识别代码 受试者招募受试者筛选表检验单晶 X-射线衍射系统稽查T1/2Target variable T-BILT-CHOTest product TGTLC、HPLCTmax TPTransformation Treatment group Trial errorTrial initial meeting Trial master file Trial objectiveTrial site Triple blindingTwo one-side test Un-blindingUnexpected adverse event，UAE UV-VISVariability目标变量 总胆红素 总胆固醇 受试制剂 热重分析 制备色谱 峰时间总 蛋 白 试 验 组 试验总档案 试验目的三盲揭盲预料外不良事件紫外-可见吸收光谱变异VariableVisual analogy scale Visual check Vulnerable subject Wash-outWashout period血常规WBC white blood cell count GR% granulocyte LY%lymphocyteMID%EOS% eosimophilAL% allergy lymphocyte ST%RBC red blood cell