临床研究专业术语缩略语中英对照表.docxVIP

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Clinical 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 Trial 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Endpoint 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 Investigator’s Brochure 研究者手册IC Informed Consent 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 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