药物临床试验英文缩写缩略语 英文全称 中文全称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 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GMP Good Manufacturing Practice 药品生产质量管理规范IB Investigators 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MCA Medicines 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NEC New Drug Entity 新化学实体NIH National Institutes of Health 国家卫生研究所（美国）PI Principal Investigator 主要研究者PL Product License 产品许可证PMA Pre-market Approval (Application) 上市前许可（申请）PSI Statisticians in the Pharmaceutical Industry 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SA Site Assessment 现场评估SAE Serious Adverse Event 严重不良事件SAP 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 Data Verification 原始数据核准SEL Subject Enrollment Log 受试者入选表SI Sub-investigator 助理研究者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SPL Study Personnel List 研究人员名单SSL Subject Screening Log 受试者筛选表T&R Test and Reference Product 受试和参比试剂UAE Unexpected Adverse Event 预料外不良事件WHO World Health Organization 世界卫生组织WHO-ICDRAWHO International Conference of Drug Regulatory AuthoritiesWHO国际药品管理当局会议 药物临床试验英文缩写英文全称 中文全称Accuracy准确度Active control, AC阳性对照 活性对照Adverse drug reaction, ADR药物不良反应Adverse event, AE不良事件Adverse medical events不良医学事件Adverse reaction药物不良反应Alb白蛋白ALD（Approximate Lethal Dose）近似致死剂量ALP碱性磷酸酶Alpha spending function消耗函数ALT丙氨酸氨基转换酶Analysis sets统计分析的数据集Approval批准Assistant investigator助理研究者AST天门冬酸氨基转换酶ATR衰减全反射法AUCss稳态血药浓度时间曲线下面积Audit 稽查Audit or inspection稽查视察Audit report 稽查报告Auditor稽查员Bias偏性 偏倚Bioequivalence生物等效应Blank control空白对照Blind codes编制盲底Blind review盲态审核Blind review 盲态检查Blinding method盲法Blinding/masking盲法/设盲Block层Block size每段的长度Carryover effect延滞效应Case history病历Case report fo