1、临床研究常用术语缩写表编号 术语缩写 英文全称/中文全称ADR Adverse drug reaction/不良反应AE Adverse Event/不良事件ASV Accompanied Site Visit/陪同访视BD 业务拓展 Business DevelopmentBS 生物统计 BiostatisticsCCF Central Clinical File 申办方临床研究文件夹CD Controlled Documents/控制文件CDA Confidentiality Disclosure Agreement/保密协议CDC Center for Disease Control/疾
2、病控制中心CSDs Clinical Study Documents临床研究文件CEC Central Ethics Committee/中心伦理委员会Co-I Coordinating Investigator 负责协调不同中心参加多中心临床试验研究者的研究者COF Change Order Form/工作范围变更申请表CIF Central Investigators File 申办者 研究者文件夹（中心研究者文件夹）CM Clinical Monitoring / Operations/临床监查/运营CMA Clinical Monitoring Associate/临床研究监查助理CR
3、 Complete Response 痊愈CRA Clinical Research Associate (equivalent to Clinical Study Monitor)临床监查员CRC Clinical Research Coordinator/临床研究协调员CRF Case Report Form or Case Record Form/病例报告表CRO Contract Research Organization/合同研究组织CSDs Clinical Study Documents/临床研究文件CSR Clinical Study Report/临床研究报告CTA Clin
4、ical Trial Assistant (equivalent to Clinical Research Assistant)临床研究助理CTA Clinical Trial Agreement/临床试验协议CTA Clinical Trial Application/临床试验申请CTS Clinical Trial Supplies/临床试验用品CTX Clinical Trial Exemption/临床试验免责CV Curriculum Vitae/履历DCF Data Clarification Form /数据澄清表DCR Data Clarification Report (se
5、e DCF)/数据澄清报告DCRF Data Clarification and Resolution Form (see DCF)/数据澄清和解决表DM Data Management/数据管理DMP Data Management Plan/数据管理计划书编号 术语缩写 英文全称/中文全称DQF Data Query Form/数据疑问表DS Data Source/数据源EC Ethics Committee /伦理委员会eCRF Electronic Case Report Form/电子病历报告表EDC Electronic Data Capture/电子数据采集EOS End of
6、 Study/研究结束EU European Union/欧盟FAS Full Analysis Set/全分析集FDA Food and Drug Administration/美国食品药品管理局FM Approved Standard Form/批准的标准表格GCP Good Clinical Practice/临床试验质量管理规范GLP Good Laboratory Practice /实验室质量管理规范GMP Good Manufacturing Practice/药品生产质量管理规范GRP Good Research Practice/科学研发质量管理规范GSP Good Stat
7、istical Practice/统计质量管理规范HCO Head of Clinical Operations 临床运营总监IB Investigators Brochure/研究者手册IC Informed Consent/ 知情同意ICF Informed Consent Form (also see IC)/知情同意书ICH International Conference on Harmonization/国际协调会议ICH-GCPInternational Conference on Harmonisation Tripartite Guideline on Good Clinic
8、al Practice国际协调会议药品临床试验质量管理规范指南IDB Investigational Drug Brochure /试验药物手册IEC Independent Ethic Committee/独立伦理委员会IND Investigational New Drug (US FDA)/研究用新药IP Investigational Product/研究用产品IRAEs Immediately Reportable Adverse Events/立即上报的不良事件IRB Institutional Review Board. /机构审查委员会ITT Intention to trea
9、t/意向性治疗ISA Investigator Study Agreement/研究者合同ISF Investigational Site File 研究者文件夹LM Line Manager/直线经理LOI Letter of Intent/意向书MOH Ministry of Health/卫生部MSA Master Services Agreement/主服务协议MTD Maximum Tolerated Dose/最大耐受剂量MW Medical Writing/医学写作NA Not Available/不可用NCE New Chemical Entity/新化学实体NCS Not C
10、linically Significant/无临床意义ND Not Done/未做编号 术语缩写 英文全称/中文全称NDA New Drug Application./新药上市申请OD Other Documents/其他文件OP Operating Procedure/操作规程OOS Out Of Scope/超工作范围OS Overall Survival/总体生存期OTL Operational Team Lead/运营团队负责人PD Protocol Deviation/方案偏离PI Principle Investigator /主要研究者 PIN Personal Identifi
11、cation Number/个人确认密码PK Pharmacokinetics/药物代谢动力学PM Project Manager/项目经理PMF Project Managerment File/项目管理文件夹PMI Periodic Maintenance Inspection/定期维护检查PMS Post-Marketing Surveillance/上市后药物检测PP Project Plan/项目计划PP Per Protocol/符合方案集PR Patient Recruitment/患者招募QA Quality Assurance/质量管理QC Quality Control/质
12、量控制RA Regulatory Authorities/监督管理部门RM Remote Monitoring/远程监查On-Site Monitoring/现场监查=On-Target Monitoring/目标化监查SAE Serious Adverse Event /严重不良事件SC Study Coordinator/研究协调员SCV Site Close-out Visit/中心关闭访视SSV Site Selection Visit/中心筛选访视SMV Site Monitoring Visit/中心监查访视SVR Site Visit Report/中心访视报告SD Source
13、 Data/源数据SDV Source Data Verification/原始数据核查SFDA State Food and Drug Administration/国家食品药品监督管理局SIC Subject Identification Code/受试者识别代码SIF Site Information Form/中心信息表SIV Site Initiation Visit/中心启动访视SOP Standard Operating Procedure/标准操作规程SOW Scope of Work/工作范围Sub-I Subinvestigator 次要研究者SUSAR Suspected
14、 Unexpected Serious Adverse Reaction可疑的非预期的严重不良反应TP Template/模版TMF Trial Master File/试验主文档UADR Unexpected Adverse Drug Reaction/非预期药物不良反应编号 术语缩写 英文全称/中文全称UADE Unanticipated adverse drug effect/非预期的不良反应UAE Unexpected adverse event/非预期的不良事件WI Work Instruction/工作指南SOP 类型缩写表OP 操作规程 Operating ProceduresW
15、I 工作指南 Work InstructionsTP 模板 TemplateFM 批准的标准表格 Approved Standard FormsOD 其他文件 Other Documents业务部门缩写表/ Functional Area Abbreviation Table:BS 生物统计 BiostatisticsBD 业务拓展Business DevelopmentCM 临床监查/运营Clinical Monitoring/OperationDM 数据管理 Data ManagementIT 信息技术 Information TechnologyMS 医学科学服务Medical Scie
16、nce ServicePM 项目管理 Project ManagementQA 质量保证 Quality AssuranceRM 记录管理 Records ManagementRA 注册事务Regulatory AffairsSM SOP 管理 SOP ManagementST 研究中心管理服务Site Management ServiceTR 培训 Training试验主文档：（TMF） Trial Master FilePMF 项目管理文件夹 Project Management FileCCF 申办方临床研究文件夹 Central Clinical File CIF 申办方- 研究者文件夹 Central Investigator File ISF 研究者文件夹 Investigator Site File BSF 生物统计学文件夹 Biostatistics Study File DMSF 数据管理研究文件夹 Data Management Study File
