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1、欧阳引擎创编2021.01.01专业术语欧阳引擎(2021.01.01)缩略语英文全称DCF data clarification formSDV source data verification中文全称数据澄清表，用于纸质query原始数据核对ADE Adverse Drug Event药物不良事件药物不良反应ADR Adverse Drug ReactionAE Adverse Event不良事件Al Assistant Investigator助理研究者BMI Body Mass Index体质指数CI Co-investigatorCOI Coordinating Investigat
2、orCRA Clinical Research Associate合作研究者协调研究者临床监查员（临床监察员)CRC Clinical Research Coordinator 临床研究协调者CRF Case Report Form病历报告表欧阳引擎创编2021.01.01欧阳引擎创编2021.01.01CRO Contract Research Organization合同研究组织CSA Clinical Study Application临床研究申请CT A Clinical Trial Application临床试验申请CTX Clinical Trial Exemption临床试验免责
3、CTP Clinical Trial Protocol临床试验方案CTR Clinical Trial Report临床试验报告DSMB Data Safety and monitoring Board 数据安全及监控委员合EDC Electronic Data Capture电子数据采集系统EDP Electronic Data Processing电子数据处理系统FDA Food and Drug Administration美国食品与药品管理FR Final Report总结报告GCP Good Clinical Practice药物临床试验质量管理规范GLP Good Laborato
4、ry Practice药物非临床试验质量管理药品生产质量管理规范规范GMP Good Manufacturing PracticeIBInvestigator Brochure研究者手册ICInformed Consent知情同意ICFInformed Consent Form知情同意书ICHInternational Conference on Harmonization 国际协调会议IDMIndependent Data Monitoring 独立数据监察IDMC Independent Data Monitoring Committee 独立数据监察委欧阳引擎创编2021.01.01员会
5、IECIndependent Ethics Committee独立伦理委员会INDInvestigational New Drug新药临床研究IRBInstitutional Review Board机构审查委员合IVDIn Vitro Diagnostic体外诊断IVRSInteractive Voice Response System 互动语音应答系统MAMarketing Approval/Authorization 上市许可证MCAMedicines Control Agency英国药品监督局MHWr Ministry of Health and Welfare日本卩牛福利部NDANe
6、w Drug Application新约甲请NECNew Drug Entity新化学实体NIHNational Institutes of Health国家卫生硏究所（美国）PIPrincipal Investigator主要研究者PLProduct License产品许可证PMAPre-market Approval (Application)上市前许可(申请)PSIStatisticians in the Pharmaceutical Industry 制药业统计学家协会欧阳引擎创编2021.01.01QAQuality Assurance质量保证QCQuality Control质量控
7、制RARegulatory Authorities监督管理部门SASite Assessment现场评估SAESerious Adverse Event严重不良事件欧阳引擎创编2021.01.01欧阳引擎创编2021.01.01SAP Statistical Analysis Plan统计分析计划SAR Serious Adverse Reaction严重不良反应SD Source Data/Document原始数据/文件SD Subject Diary受试者日记SFDA State Food and Drug Administration 国家食品药品监督管 理局SDV Source Dat
8、a Verification 原始数据核准SEL Subject Enrollment Log受试者入选表SI Sub-investigator助理硏究者SI Sponsor-Investigator申办研究者SIC Subject Identification Code受试者识别代码SOP Standard Operating Procedure 标准操作规程研究人员名单受试者筛选表受试和参比试剂预料外不良事件世界卫生组织SPL Study Personnel ListSSL Subject Screening LogT&R Test and Reference ProductUAE Une
9、xpected Adverse EventWHO World Health OrganizationWHO-ICDRA WHO International Conference of Drug RegulatoryAuthorities WHO国际药品管理当局会议Active Control阳性对照、活性对照Audit稽查Audit Report稽查报告欧阳引擎创编2021.01.012021.01.01欧阳引擎创编Coordinating CommitteeCross-over StudyDouble BlindingEndpoint Criteria/measurementEssentia
10、l DocumentationExclusion CriteriaInclusion CriteriaInformation GatheringInitial MeetingAuditorBlank ControlBlinding/maskingCase HistoryClinical studyClinical TrialClinical Trial ReportComplianceInspectionInstitution InspectionInvestigational ProductInvestigatorMonitor稽查员空白对照盲法/设盲病历临床研究临床试验临床试验报告 依从性
11、协调委员会交叉研究双盲终点指标必需文件排除标准入选表准信息收集启动会议检察/视察机构检察试验药物研究者监查员（监察员）2021.01.01欧阳引擎创编2021.01.01欧阳引擎创编病人档案病历安慰剂安慰剂对照临床前研究试验方案修正案随机参比制剂样本量、样本大小严重性严重程度单盲申办者MonitoringMonitoring PlanMonitoring ReportMulti-center TrialNon-clinical StudyOriginal Medical RecordOutcome AssessmentPatient FilePatient HistoryPlaceboPlac
12、ebo ControlPreclinical StudyProtocolProtocol AmendmentsRandomizationReference ProductSample SizeSeriousnessSeveritySingle BlindingSponsorStudy Audit监查（监察）监查计划（监察计划）监查报告（监察报告）多中心试验非临床研究原始医疗记录结果评价研究稽查2021.01.01欧阳引擎创编Subject受试者Subject Enrollment受试者入选Subject Enrollment Log受试者入选表欧阳引擎创编2021.01.01Subject Identification Code List 受试者识别代码表Subject Recmitment迸试者招募Study Site硏究中心Subject Screening Log受试者筛选表System Audit系统稽查Test Product受试制剂Trial Initial Meeting试也启动n议Trial Master File试验总档案Trial Objective试验目的Triple Blinding三盲Wash-out洗脱Wash-out Period洗脱期2021.01.01欧阳引擎创编
