临床研究专业术语、缩略语中英对照表(4页).doc

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1、-Active Control 阳性对照、活性对照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Audit Report 稽查报告Audit 稽查Auditor 稽查员Blank Control 空白对照Blinding/masking 盲法/设盲BMI Body Mass Index 体质指数Case History 病历CI Co-investigator 合作研究者Clinical study 临床研究Clin

2、ical Trial Report 临床试验报告Clinical Trial 临床试验COI Coordinating Investigator 协调研究者Compliance 依从性Coordinating Committee 协调委员会CRC Clinical Research Coordinator 临床研究协调者CRF Case Report Form 病历报告表CRO Contract Research Organization 合同研究组织Cross-over Study 交叉研究CSA Clinical Study Application 临床研究申请CTA Clinical T

3、rial Application 临床试验申请CTP Clinical Trial Protocol 临床试验方案CTR Clinical Trial Report 临床试验报告CTX Clinical Trial Exemption 临床试验免责Double Blinding 双盲DMP数据管理计划DSMB Data Safety and monitoring Board 数据安全及监控委员会DVP数据核查计划eCRF电子病历报告EDC Electronic Data Capture 电子数据采集系统EDP Electronic Data Processing 电子数据处理系统Endpoin

4、t Criteria 终点指标Essential Documentation 必需文件Exclusion Criteria 排除标准FDA Food and Drug Administration 美国食品与药品管理局FR Final Report 总结报告GCP Good Clinical Practice 药物临床试验质量管理规范GCP Good Laboratory Practice 药物非临床试验质量管理规范GMP Good Manufacturing Practice 药品生产质量管理规范IB Investigators Brochure 研究者手册IC Informed Conse

5、nt 知情同意ICF Informed Consent Form 知情同意书ICH International Conference on Harmonization 国际协调会议IDM Independent Data Monitoring 独立数据监察IDMC Independent Data Monitoring Committee 独立数据监察委员会IEC Independent Ethics Committee 独立伦理委员会Inclusion Criteria 入选表准IND Investigational New Drug 新药临床研究Information Gathering

6、信息收集Initial Meeting 启动会议Inspection 检察/视察Institution Inspection 机构检察Investigational Product 试验药物Investigator 研究者IRB Institutional Review Board 机构审查委员会IVD In Vitro Diagnostic 体外诊断IVRS Interactive Voice Response System 互动语音应答系统MA Marketing Approval/Authorization 上市许可证MCA Medicines Control Agency 英国药品监督

7、局MHW Ministry of Health and Welfare 日本卫生福利部Monitor 监察员Monitoring Plan 监察计划Monitoring Report 监察报告Monitoring 监察Multi-center Trial 多中心试验NDA New Drug Application 新药申请NEC New Drug Entity 新化学实体NIH National Institutes of Health 国家卫生研究所（美国）Non-clinical Study 非临床研究Original Medical Record 原始医疗记录Outcome Assess

8、ment 结果评价Patient File 病人档案Patient History 病历PI Principal Investigator 主要研究者PL Product License 产品许可证Placebo Control 安慰剂对照Placebo 安慰剂PM项目经理PMA Pre-market Approval (Application) 上市前许可（申请）PMP项目组建立Preclinical Study 临床前研究Protocol Amendments 修正案Protocol 试验方案PSI Statisticians in the Pharmaceutical Industry

9、制药业统计学家协会QA Quality Assurance 质量保证QC Quality Control 质量控制RA Regulatory Authorities 监督管理部门Randomization 随机Reference Product 参比制剂Regulatory AuthoritiesSA Site Assessment 现场评估SAE Serious Adverse Event 严重不良事件Sample Size 样本量、样本大小SAP Statistical Analysis Plan 统计分析计划SAR Serious Adverse Reaction 严重不良反应SD So

10、urce Data/Document 原始数据/文件SD Subject Diary 受试者日记SDV Source Data Verification 原始数据核准SEL Subject Enrollment Log 受试者入选表Seriousness 严重性Severity 严重程度SFDA State Food and Drug Administration 国家食品药品监督管理局SI Sponsor-Investigator 申办研究者SI Sub-investigator 助理研究者SIC Subject Identification Code 受试者识别代码Simple Rando

11、mization 样本量、样本大小Single Blinding 单盲SOP Standard Operating Procedure 标准操作规程SPL Study Personnel List 研究人员名单Sponsor 申办者SSL Subject Screening Log 受试者筛选表Study Audit 研究稽查Study Site 研究中心Subject Enrollment Log 受试者入选表Subject Enrollment 受试者入选Subject Identification Code List 受试者识别代码表Subject Recruitment 受试者招募Su

12、bject Screening Log 受试者筛选表Subject 受试者System Audit 系统稽查T&R Test and Reference Product 受试和参比试剂Test Product 受试制剂Trial Initial Meeting 试验启动会议Trial Master File 试验总档案Trial Objective 试验目的Triple Blinding 三盲UAE Unexpected Adverse Event 预料外不良事件UAT用户接受测试Un-blinding 洗脱Wash-out PeriodWash-out 洗脱期WHO International Conference of DrugWHO World Health Organization 世界卫生组织WHO 国际药品管理当局会议WHO-ICDR A-第 4 页-