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1、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AE Adverse Event 不良事件BMI Body Mass Index 体质指数ADR Adverse Drug Reaction 药物不良反应 AI Assistant Investigator 助理研究者 CI Co-investigator 合作研究者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 CR
2、F 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
3、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GMP Good Manufacturing Practice药品生产质量管理规范IB Investigators Brochure研究者手册IC Informed C
4、onsent 知情同意ICF Informed Consent Form 矢口情同意书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 Institutiona
5、l 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
6、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
7、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 Subject identification code （SIC）受试者识别代码 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
8、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pd pharmacodynamics 药物效应动力学SOP Standard Operating Procedure 标准操作规程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 Unexp
9、ected 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 国际药品 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
10、 Clinical study 临床研究Clinical Trial 临床试验 Clinical Trial Report 临床试验报告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 必需文件Exclusion Criteria 排除标准Inclusion Criteria 入选表准Information Gathering 信息收集Initial Meeti
11、ng 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 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多中心试验Non-clinical Study 非临床研究 Original Medical Record 原始医疗记录 Outcome Assessment 结果评价Patient File 病人
12、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 试验方案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 严重程度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
13、者入选表Subject Identification Code List 受试者识别代码表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 试验启动会议 Trial Master File 试验总档案 Wash-out 洗脱Trial Objective 试验目的 Triple Blinding 三盲 Wash-out Period 洗脱期Alb白蛋白 ALD(Approximate Lethal Do
14、se)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统计分析的数据集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稳态血药浓度一时间曲线下面积Standard operating procedure (SOP)标准操作规程Case report form/ case record form(CRF)病 例报告表病例记录表Clinical trial application (CTA)临床试验申请Clinical
15、trial exemption (CTX) 床试验免责Clinical trial protocol (CTP)临床试验方案Contract research organization (CRO)合 同研究组织Computer-assisted trial design (CATD)计算机辅助试验设计Source data (SD)原始数据Electronic data capture (EDC)电子数据采集系统Source data verification (SDV)原 始数据核准Electronic data processing (EDP)电子数据处理系统Subject enrollm
16、ent log 受试者入选表Institution review board (IBR)机构审查委员会Intention-to-treat (ITT)意向性分析(一统计学)Interactive voice response system (IVRS互动式语音应答系统Investigators brochure (IB )研究者手册Maximum Tolerated Dose (MTD)最大耐受剂量Principle investigator (PI)主 要研究者Product license (PL)产品许可证Serious adverse event (SAE)严重不良事件Serious ad
