临床专业术语英中文对照

专业术语英中文对照TTRtime-to-progression疾病进展时间SAEseverityAdverseEvent严重不良事件AEAdverseEvent不良事件SOPStandardOperatingProcedure标准操作规程CRFCaseReportform病例报告表DLT:剂量限制毒性MTD最大耐受剂量KPSKarnofskyPerformanceStatus行为状态评分CRcompleteresponse完全缓解PRpartialresponse部分缓解SD病情稳定PDprogressivedisease病情进展CTC常用药物毒性标准IEC:independentethicscommittee独立伦理委员会IRB:institutionalreviewboard伦理委员会CRA临床研究助理CROContractResearchOrganization合同研究组织DFSDiseaseFreeSurvival无病生存期OS(OverallSurvival)总生存时间IC:Informedconsent知情同意ADRAdverseDrugReaction不良反应GAPGoodAgriculturalPractice中药材种植管理规范GCPGoodClinicalPractice药物临床试验质量管理规范GLPGoodLaboratoryPractice药品实验室管理规范GMPGoodManufacturingPractice药品生产质量管理规范GSPGoodSupplyPractice药品经营质量管理规范GUPGoodUsePractice药品使用质量管理规范PI:Principalinvestigator主要研究者CI:Co-inveatigator合作研究者SI:Sub-investigator助理研究者COI:Coordinatinginvestigtor协调研究者DGMP医疗器械生产质量管理规范ICF:Informedconsentform知情同意书RCT：randomizedcontrolledtrial,随机对照试验NRCCTnon-randomizedconcurrentcontrolledtrial,非随机同期对照试验EBMevidence-basedmedicine循证医学RCDrandomizedcross-overdisgn随机交*对照试验HCThistorialcontroltrial,历史对照研究RECISTResponseEvaluationCriteriaInSolidTumors.实体瘤疗效反应的评价标准QCQualityControl质量控制UADRUnexpectedAdverseDrugReaction,非预期药物不良反应ActivecontrolAC

阳性对照，活性对照AdversedrugreactiveADR药物不良反应Audit稽查Bias偏差blankControl空白对照Blinding/asking盲法Casehistory病历Clinicaltrial临床试验Clinicaltrialapplication,CTA临床试验中请Clinicaltrialexemption,CTX临床试验免责Clinicaltrialprotocol,CTP临床试验方案Clinicaltrial/studyreport临床试验报告Co-investigator合作研究者Comparison对照Compliance/obedience依从性Computer-assistedtrialdesignCATD计算机辅助试验设计Coordinatingcommittee协调委员会Cross-overstudy交叉研究Documentation文件Dose-reactionrelation齐【J量-反应关系doubleblinding双盲终点指标electronicdatacapture/processing电子数据采集/处理系统终点指标endpointcriteria/measurement

exclusioncriteria排除标准exclusioncriteria排除标准genericdrug通用名药healtheconomicevaluation,HEV健康经济学评价hypothesistesting假设检验inclusioncriteria入选标准informationgathering信息收集initialmeeting启动会议inspection视察/检查intentiontotreat意向治疗interactivevoiceresponsesystem,IVRS互动式语音应答系统internationalconferenceonharmonization国际协调会议investigationalnewdrug,IND新药临床研究marketingapproval/authorization上市许可证newchemicalentity新化学实体newdrugapplication,NDA新药申请optionaltitration随意滴定patientfile病人档案placebo安慰剂principleinvestigator,PI主要研究者productlicense,PL产品许可证protocolamendment方案补正qualityassurance,QA质量保证qualityassuranceunit,QAU质量保证部门qualitycontrol,QC质量控制randomization随机化runin准备期samplesize样本量，样本大小seriousness严重性severity严重程度siteaudit试验机构稽查sourcedata/sourcedocument,SD原始数据sourcedataverification,SDV原始数据核准statisticalanalysisplan,SAP统计分析计划subjectdiary受试者日记subjectenrollment受试者筛选subjectenrollmentlog受试者入选表subjectidentificationcode,SIC受试者识别代码subjectrecruitment受试者招募subjectscreeninglog受试者筛选表trialerror试验误差