专业术语缩略语 英文全称 中文全称ADE Adverse Drug Event 药物不良事件 ADR Adverse Drug Reaction 药物不良反映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 合伙研究者COI Coordinating Investigator 协调研究者 CRA Clinical Research Associate临床监查员(临床监察员) 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 ECRF 电子化病历报告表CSA Clinical Study Application 临床研究申请 CTA Clinical Trial Application 临床实验申请CTX Clinical Trial Exemption 临床实验免责 CTP Clinical Trial Protocol 临床实验方案CTR Clinical Trial Report 临床实验报告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 电子数据解决系统FDA Food and Drug Administration 美国食品与药物管理局 FR Final Report 总结报告GCP Good Clinical Practice 药物临床实验质量管理规范 GLP Good Laboratory Practice 药物非临床实验质量管理规GMP Good Manufacturing Practice 药物生产质量管理规范IB Investigator’s Brochure研究者手册 IC Informed Consent 知情批准ICF Informed Consent Form 知情批准书 ECG Electrocardiogram心电图ICH International Conference on Harmonization 国际协调会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 MA Marketing Approval/Authorization 上市许可证IVRS Interactive Voice Response System 互动语音应答系统MCA Medicines Control Agency 英国药物监督局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 重要研究者 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 制药业记录学家协会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 记录分析计划SAR Serious Adverse Reaction 严重不良反映 SD Source Data/Document 原始数据 /文献SD Subject Diary 受试者日记 Subject identification code (SIC)受试者辨认代码SFDA State Food and Drug Administration 国家食品药物监督管理局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 受试者辨认代码 pd pharmacodynamics药物效应动力学SOP Standard Operating Procedure 原则操作规程 pk pharmacokinetics药物代谢动力学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 Active Control 阳性对照、活性对照WHO-ICDRA WHO International Conference of Drug Regulatory Authorities WHO国际药物 管理当局会议 Unexpected adverse event (UAE)预料外不良事件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 临床实验 Clinical Trial Report 临床实验报告 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 必需文献Exclusion Criteria 排除原则 Inclusion Criteria 入选表准 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 实验药物 Investigator 研究者 Monitor 监查员(监察员) Monitoring 监查(监察) Monitoring Plan 监查计划(监察计划)Monitoring Report 监查报告(监察报告) Multi-center Trial 多中心实验Non-clinical Study 非临床研究 Original Medical Record 原始医疗记录Outcome Assessment 成果评价 Patient File 病人档案 Patient History 病历Placebo 安慰剂 Placebo Control 安慰剂对照 Preclinical Study 临床前研究Protocol 实验方案 Protocol Amendments 修正案 Randomization 随机Reference Product 参比制剂 Sample Size 样本量、样本大小 Seriousness 严重性Severity 严重限度 Single Blinding 单盲 Sponsor 申办者Study Audit 研究稽查 Subject 受试者 Subject Enrollment 受试者入选 Subject Enrollment Log 受试者入选表 Subject Identification Code List 受试者辨认代码表 Subject Recruitment 受试者招募 Subject Screening Log 受试者筛选表System Audit 系统稽查 Study Site 研究中心 Test Product 受试制剂Trial Initial Meeting 实验启动会议 Trial Master File 实验总档案 Wash-out 洗脱Trial Objective 实验目旳 Triple Blinding 三盲 Wash-out Period 洗脱期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 Approval批准Analysis sets记录分析旳数据集 Approval批准 ATR衰减全反射法Assistant investigator助理研究者 AST天门冬酸氨基转换酶AUCss稳态血药浓度－时间曲线下面积 Standard operating procedure (SOP)原则操作规程Case report form/ case record form(CRF)病例报告表病例登记表Clinical trial application (CTA)临床实验申请 Clinical trial exemption (CTX)临床实验免责Clinical trial protocol (CTP)临床实验方案 Contract research organization (CRO)合同研究组织Computer-assisted t。