临床试验术语英汉对照.docx

1、临床试验术语英汉对照临床试验常用的英文Accuracy正确度Active control, AC阳性比较，活性比较Adverse drug reaction, ADR药物不良反响Adverse event, AE不良事件Adverse medical events不良医学事件Adverse reaction药物不良反响Alb白蛋白ALD（ Approximate Lethal Dose）近似致死剂量ALP碱性磷酸酶ALT丙氨酸氨基变换酶Analysis sets统计剖析的数据集Approval赞同Assistant investigator助理研究者AST天门冬酸氨基变换酶ATR衰减全反射法A

2、UCss稳态血药浓度时间曲线下边积Audit稽察Audit or inspection稽察视察Audit report稽察报告Auditor稽察员BiasBioequivalenceBlank controlBlind codesBlind reviewBlinding methodBlinding/ maskingBlockBlock sizeBUNCarryover effectCase historyCase report form/ case record form, CRFCategorical variableCavCLClinical equivalenceClinical st

3、udyClinical study reportClinical trialClinical trial application, CTAClinical trial exemption, CTXClinical trial protocol, CTPClinical trial/ study report偏性，偏倚生物等效应空白比较编制盲底盲态审察盲法盲法，设盲分段每段的长度尿素氮延滞效应病历病例报告表，病例记录表分类变量均匀浓度除去率临床等效应临床研究临床试验的总结报告临床试验临床试验申请临床试验免责临床试验方案临床试验报告CmaxCo-investigatorComparisonComp

4、lianceComposite variableComputer-assisted trial design, CATDConfidence intervalConfidence levelConsistency testContract research organization, CROContract/ agreementControl groupCoordinating committeeCreaCRF(case report form)Crossover designCross-over studyCssCureData managementDatabaseDescriptive s

5、tatistical analysisDFDichotomies峰浓度合作研究者比较允从性复合变量计算机协助试验设计可信区间置信水平一致性查验合同研究组织协议合同比较组协调委员会肌酐病例报告表交错设计交错研究稳浓度康复数据管理成立数据库描绘性统计剖析颠簸系统二分类DiviationDocumentationDose-reaction relationDouble blindingDouble dummyDouble dummy techniqueDouble-blindingDrop outEffectivenessElectronic data capture, EDCElectronic

6、data processing, EDPEmergency envelopeEnd pointEndpoint criteria/ measurementEquivalenceEssential documentationEthics committeeExcellentExclusion criteriaFactorial designFailureFinal pointFixed-dose procedureForced titration偏差记录文件剂量反响关系双盲双模拟双盲双模拟技术双盲零落疗效电子数据采集系统电子数据办理系统应急信函终点终点指标等效性一定文件伦理委员会显效清除标准析因

7、设计无效，失败终点固定剂量法强迫滴定Full analysis set 全剖析集GC FTIR 气相色谱傅利叶红外联用GC MS 气相色谱质谱联用Generic drug 通用名药Global assessment variable 全局评论变量GLU 血糖Good clinical practice, GCP 药物临床试验质量管理规范Good manufacture practice, GMP 药品生产质量管理规范Good non-clinical laboratory practice, 药物非临床研究质量管理规范GLPGroup sequential design 成组序贯设计Hypot

8、hesis test 假定查验International Conference of Harmonization, ICH 人用药品注册技术要求国际技术协调会，国际协调会议Improvement 好转Inclusion criteria 当选标准Independent ethics committee, IEC 独立伦理委员会Information consent form, ICF 知情赞同书Information gathering 信息采集Informed consent, IC 知情赞同Initial meeting 启动会议Inspection 视察检查Institution ins

9、pection 机构检查Institution review board, IBR 机构审察委员会Intention to treat 意愿治疗（ - 临床领域）Intention-to treat, ITT意愿性剖析 ( 统计学）Interim analysis期中剖析Investigator研究者Investigators brochure, IB研究者手册IR红外汲取光谱Ka汲取速率常Last observation carry forward, LOCF最靠近一次察看的结转LC MS液相色谱质谱联用LD多半致死剂量50Logic check逻辑检查LOQ (Limit of Quant

10、itation)定量限LOCF, Last observation carry forward近来一次察看的结转Lost of follow up失访Marketing approval/ authorization上市允许证Matched pair般配配对Missing value缺失值Mixed effect model混淆效应模式Monitor监查员Monitoring监查Monitoring report监查报告MRT均匀滞留时间MTD（ Maximum Tolerated Dose）最大耐受剂量Multi-center trial多中心试验New chemical entity, N

11、CE新化学实体New drug application, NDANMRNon-clinical studyNon-inferiorityNon-parametric statisticsObedienceODROpen-blindingOpen-labelOptional titrationOriginal medical recordOutcomeOutcome assessmentOutcome measurementOutlierParallel group designParameter estimationParametric statisticsPatient filePatien

12、t historyPer protocol, PPPlaceboPlacebo controlPolytomies新药申请核磁共振谱非临床研究非劣效性非参数统计方法允从性旋光光谱非盲非盲任意滴定原始医疗记录结果结果指标评论结果指标离群值平行组设计参数预计参数统计方法病人档案病历切合方案集宽慰剂宽慰剂比较多分类PowerPrecisionPreclinical studyPrimary endpointPrimary variablePrincipal investigatorPrinciple investigator, PIProduct license, PLProtocolProtoco

13、l amendmentQuality assurance unit, QAUQuality assurance, QAQuality control, QCQuery list, query formRandomizationRange checkRating scaleRegulatory authorities, RAReplicationRSDRun inSafety evaluationSafety setSample size查验效能精细度临床前研究主要终点主要变量主要研究者主要研究者产品允许证试验方案方案补正质量保证部门质量保证质量控制应用疑问表随机化范围检查量表监察管理部门可重复

14、日内和白天相对标准差准备期安全性评论安全性评论的数据集样本量，样本大小Scale of ordered categorical ratingsSecondary variableSequenceSerious adverse event, SAESerious adverse reaction, SARSeriousnessSeveritySignificant levelSimple randomizationSingle-blindingSite auditSource data verification, SDVSource data, SDSource document, SDSpec

15、ificitySponsorSponsor-investigatorStandard curveStandard operating procedure, SOPStatisticStatistical analysis plan, SAPStatistical modelStatistical tablesStratified有序分类指标次要变量试验序次严重不良事件严重不良反响严重性严重程度查验水平简单随机单盲试验机构稽察原始数据赞同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剖析计划统计模型统计剖析表分层Study auditSubgroupSub-investig

16、atorSubjectSubject diarySubject enrollmentSubject enrollment logSubject identification code, SICSubject recruitmentSubject screening logSuperioritySurvival analysisSXRDSystem auditT研究稽察亚组助理研究者受试者受试者日志受试者当选受试者当选表受试者辨别代码受试者招募受试者挑选表查验生计剖析单晶 X射线衍射系统稽察除去半衰期Target variableT BILT CHOTGTLC、 HPLCTmaxTPTransf

17、ormationTreatment group目标变量总胆红素总胆固醇热重剖析制备色谱峰时间总蛋白变量变换试验组Trial errorTrial master fileTrial objectiveTrial siteTriple blindingTwo one-side testUnblindingUnexpected adverse event, UAEUV VISVariabilityVariableVisual analogy scaleVisual checkVulnerable subjectWash-out periodWell-being试验偏差试验总档案试验目的试验场所三盲双单侧查验揭盲料想外不良事件紫外可见汲取光谱变异变量直观类比打分法人工检查弱势受试者洗改期福利，健康