专业术语.缩略语中英对照表.docVIP

专业术语、缩略语中英对照表 缩略语英文全称中文全称ADE Adverse Drug Event 药物不良事件ADRAdverse 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 合作研究者COI Coordinating Investigator 协调研究者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CSA Clinical Study Application 临床研究申请CTA Clinical Trial Application 临床试验申请CTX Clinical Trial Exemption 临床试验免责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会EDC Electronic Data Capture 　电子数据采集系统EDPElectronic Data Processing 电子数据处理系统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GLP Good Laboratory Practice 药物非临床试验质量管理规范GMPGood Manufacturing Practice药品生产质量管理规范IBInvestigator’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IND　Investigational New Drug 新药临床研究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MCAMedicines Control Agency 英国药品监督局MHW Ministry of Health and Welfare 日本卫生福利部NDA New Drug Application 新药申请NECNew Drug Entity 新化学实体NIHNational Institutes of Health 国家卫生研究所（美国）PI Principal 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RA Regulatory Authorities 监督管理部门SASite Assessment 现场评估SAESerious Adverse Event 严重不良事件SAPStatistical Analysis Plan 统计分析计划SARSerious Adverse Reaction