临床研究缩写

1、缩略语ADE ADRAEAI BMI CI COI CRC CRF CRO CSA CTA CTX CTP CTR DSMB英文全称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中文全称不良事件体质指数 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数据安全及监控委员会EDC EDP FDA FR GCPElectronic Data Capture Electronic Data Processing Food and Drug Administration Final

3、ReportGood Clinical Practice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GLPGood LaboratoryPractice药物非临床试验质量管理规范GMP IBIC ICF ICHGood Manufacturing Practice Investigators Brochure Informed ConsentInformed Consent FormInternational Conference on Harmonization研究者手册知情同意 国际协调会议IDM IDMCIndependent Data Monit

4、oringIndependent Data Monitoring Committee独立数据监察独立数据监察委员会IEC INDIndependent Ethics Committee Investigational New Drug独立伦理委员会新药临床研究IRB IVD IVRSInstitutional Review BoardIn Vitro DiagnosticInteractive Voice Response System机构审查委员会体外诊断互动语音应答系统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英文全称Pre-market Approval（Application）Statisticians in the Pharmaceutical Industry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（美国主要研究者产品许可证中文全称上市前许

6、可（申请） 制药业统计学家协会QAQualityAssurance质量保证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质量控制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

7、国家食品药品监督管理局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 申办研究者受试者识别代码标准操作规程SPLSPLStudy Personnel List研究人员名单SSLSubject Screening Log受试者筛选表T&RTest and Reference Product受试和参比试剂UAEUn

8、expected Adverse Event预料外不良事件WHOWorld Health Organization世界卫生组织WHO-ICDRWHO International Conference ofADrug Regulatory AuthoritiesWHO 国际药品管理当局会议药物临床试验英文缩写英文全称英文全称中文全称Accuracy准确度Active control，AC阳性对照 活性对照Adverse medical events不良医学事件Adverse reaction药物不良反应Alb白蛋白ALD（Approximate Lethal Dose）近似致死剂量ALP碱性磷酸

9、酶Alpha spending function消耗函数ALTAnalysis sets ApprovalAssistantinvestigator ASTATRAuditAudit or inspection Audit report AuditorBias Bioequivalence Blank control Blind codes Blind review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衰竭全反射法稳态血药浓度-时间曲线下面积稽查稽查/视察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/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临床等效应临床研究临床试验申请临床试验报告Cmax Comparison Complia

11、nceCompositevariableComputer-assisted trial design，CATD ConfidenceintervalConfidence level Consistency test Contract/agreement Control group Coordinating committee CreaCrossover designCross-over study CssCure峰浓度对 照 依从性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数据管理 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终点终点指标等 效 性 必须文件显效排除标准析因设计终点强制滴定 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 假设检验假设检验好

15、转入选标准独立伦理委员会知情同意书视察/机构检查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混合效应模式监察员监查监察计划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随意滴定原始医疗记录结果结果评价/结果指标评价结果指标离群值参数估计病人档案病历安慰剂多分类检验效能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 Sever

20、ity Significant levelSimple randomization Single blindingSite audit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原始数据原始文件特异性申办者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统计分析表分层研究稽查研究中心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亚组助理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X-系统稽查目标变量 总胆红素 总胆固醇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 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UV-VISVariableVisual 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%紫外-变异变量直观类比打分法人工检查弱势