临床试验常用术语缩写

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

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

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 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 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 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－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 trial exemption (CTX)临床试验免责

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