临床试验常用的英文缩写

1、专业术语中文全称缩略语 英文全称DCF data clarification formSDV source data verification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ADR Adverse Drug Reaction药物不良反应AE Adverse Event不良事件AI Assistant Investigator助理研究者BMI Body Mass Index体质指数CI Co-investigator 作研究者COI Coordinating InvestigatorCRA Clinical Research A

2、ssociateCRC Clinical Research CoordinatorCRF Case Report FormCRO Contract Research OrganizationCSA Clinical Study ApplicationCTA Clinical Trial ApplicationCTXClinical Trial ExemptionCTPClinical Trial ProtocolCTRClinical Trial ReportDSMB Data Safety and monitoring BoardEDCElectronic Data Capture系统EDP

3、 Electronic Data ProcessingFDA Food and Drug AdministrationFR Final Report 报告GCP Good Clinical Practice 规范GLPGood Laboratory Practice合协调研究者临床监查员（临床监察员）临床研究协调者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电子数据采集电子数据处理系统 美国食品与药品管理局 总结药物临床试验质量管理药物非临床试验质量管理规范学习参考GMP Good Manufacturing Practice药品生产

4、质量管理规范 研究者手册IBInvestigator s BrochureICInformed 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IDMCIndependent Data Monitoring Committee独立数据监察委员会IECIndependent Ethics Committee独立伦理委员会INDInvestigational New Drug新药临床研究IRBIn

5、stitutional Review Board机构审查委员会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MHWMinistry of Health and Welfare日本卫生福利部NDANew Drug Application新药申请NECNew Drug Entity新化学实体NIHNational Institutes of Health国家卫

6、生研究所（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QAQuality Assurance质量保证QCQuality Control质量控制RARegulatory Authorities监督管理部门SASite Assessment现场评估SAESerious Adverse Event严重不良事件SAPStatistical

7、Analysis Plan统计分析计划SARSerious Adverse Reaction严重不良反应SDSource Data/Document原始数据 / 文件SDSubject Diary受试者日记SFDAState Food and Drug Administration国家食品药品监督管理局学习参考SDVSource Data Verification原始数据核准SELSubject Enrollment Log受试者入选表SISub-investigator助理研究者SISponsor-Investigator申办研究者SICSubject Identification Code

8、受试者识别代码SOPStandard Operating Procedure标准操作规程SPLStudy 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UAEUnexpected Adverse Event预料外不良事件WHOWorld Health Organization世界卫生组织WHO国WHO-ICDRA WHO International Conference of Drug Regulatory Authorities 际药品管理当局会议Active Con

9、trol阳性对照、活性对照Audit稽查Audit Report稽查报告Auditor稽查员Blank Control空白对照Blinding/masking盲法 / 设盲Case History病历Clinical study临床研究Clinical Trial临床试验Clinical Trial Report临床试验报告Compliance依从性Coordinating Committee协调委员会Cross-over Study交叉研究Double Blinding双盲Endpoint Criteria/measurement终点指标Essential Documentation必需文件

10、Exclusion Criteria排除标准Inclusion Criteria入选表准Information Gathering信息收集Initial Meeting启动会议Inspection察检察/视Institution Inspection机构检察学习参考原始医疗记录结果评价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单盲申办者研究稽查受试者受试者入选受试者入选表受试者识别代码表受试者招募研究中Investigational ProductInvestigatorMonitor（监察员）Monitoring察）Monitoring Pl

11、anMonitoring ReportMulti-center TrialNon-clinical StudyOriginal Medical RecordOutcome AssessmentPatient FilePatient HistoryPlaceboPlacebo ControlPreclinical StudyProtocolProtocol AmendmentsRandomizationReference ProductSample SizeSeriousnessSeverity度Single BlindingSponsorStudy AuditSubjectSubject EnrollmentSubject Enrollment LogSubject Identification Code ListSubject RecruitmentStudy Site心Subject Screening LogSystem AuditTest Product试