临床英语术语缩写表

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ADRAdverse drug reaction/不良反应AEAdverse Event/不良事件ASVAccompanied Site Visit/陪同访视BD业务拓展Business DevelopmentBS生物统计 BiostatisticsCCFCentral Clinical File申办方临床研究文件夹CDControlled Documents/控制文件CDAConfidentiality Disclosure Agreement/保密协议CDCCenter for Disease Control/疾病控制中心CSDsClin

2、ical Study Documents临床研究文件CECCentral Ethics Committee/中心伦理委员会Co-ICoordinating 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COFChange Order Form/工作范围变更申请表CIFCentral Investigators File申办者研究者文件夹（中心研究者文件夹）CMClinical Monitoring / Operations/临床监查/运营CMAClinical Monitoring Associate/临床研究监查助理CRComplete Response痊愈CRAC

3、linical Research Associate (equivalent to Clinical Study Monitor)临床监查员CRCClinical Research Coordinator/临床研究协调员CRFCase Report Form or Case Record Form/病例报告表CROContract Research Organization/合同研究组织CSDsClinical Study Documents/临床研究文件CSRClinical Study Report/临床研究报告CTAClinical Trial Assistant (equivalent

4、 to Clinical Research Assistant)临床研究助理CTAClinical Trial Agreement/临床试验协议CTAClinical Trial Application/临床试验申请CTSClinical Trial Supplies/临床试验用品CTXClinical Trial Exemption/临床试验免责CVCurriculum Vitae/履历DCFData Clarification Form /数据澄清表DCRData Clarification Report (see DCF)/数据澄清报告DCRFData Clarification and

5、 Resolution Form (see DCF)/数据澄清和解决表DMData Management/数据管理DMPData Management Plan/数据管理计划书DQFData Query Form/数据疑问表DSData Source/数据源ECEthics Committee /伦理委员会eCRFElectronic Case Report Form/电子病历报告表EDCElectronic Data Capture/电子数据采集EOSEnd of Study/研究结束EUEuropean Union/欧盟FASFull Analysis Set/全分析集FDAFood an

6、d Drug Administration/美国食品药品管理局FMApproved Standard Form/批准的标准表格GCPGood Clinical Practice/临床试验质量管理规范GLPGood Laboratory Practice /实验室质量管理规范GMPGood Manufacturing Practice/药品生产质量管理规范GRPGood Research Practice/科学研发质量管理规范GSPGood Statistical Practice/统计质量管理规范HCOHead of Clinical Operations临床运营总监IBInvestigato

7、rs Brochure/研究者手册ICInformed Consent/ 知情同意ICFInformed Consent Form (also see IC)/知情同意书ICHInternational Conference on Harmonization/国际协调会议ICH-GCPInternational Conference on Harmonisation Tripartite Guideline on Good Clinical Practice国际协调会议药品临床试验质量管理规范指南IDBInvestigational Drug Brochure /试验药物手册IECIndepe

8、ndent Ethic Committee/独立伦理委员会INDInvestigational New Drug (US FDA)/研究用新药IPInvestigational Product/研究用产品IRAEsImmediately Reportable Adverse Events/立即上报的不良事件IRBInstitutional Review Board. /机构审查委员会ITTIntention to treat/意向性治疗ISAInvestigator Study Agreement/研究者合同ISFInvestigational Site File 研究者文件夹LMLine M

9、anager/直线经理LOILetter of Intent/意向书MOHMinistry of Health/卫生部MSAMaster Services Agreement/主服务协议MTDMaximum Tolerated Dose/最大耐受剂量MWMedical Writing/医学写作NANot Available/不可用NCENew Chemical Entity/新化学实体NCSNot Clinically Significant/无临床意义NDNot Done/未做NDANew Drug Application./新药上市申请ODOther Documents/其他文件OPOpe

10、rating Procedure/操作规程OOSOut Of Scope/超工作范围OSOverall Survival/总体生存期OTLOperational Team Lead/运营团队负责人PDProtocol Deviation/方案偏离PIPrinciple Investigator /主要研究者 PINPersonal Identification Number/个人确认密码PKPharmacokinetics/药物代谢动力学PMProject Manager/项目经理PMFProject Managerment File/项目管理文件夹PMIPeriodic Maintenanc

11、e Inspection/定期维护检查PMSPost-Marketing Surveillance/上市后药物检测PPProject Plan/项目计划PPPer Protocol/符合方案集PRPatient Recruitment/患者招募QAQuality Assurance/质量管理QCQuality Control/质量控制RARegulatory Authorities/监督管理部门RMRemote Monitoring/远程监查On-Site Monitoring/现场监查=On-Target Monitoring/目标化监查SAESerious Adverse Event /严

12、重不良事件SCStudy Coordinator/研究协调员SCVSite Close-out Visit/中心关闭访视SSVSite Selection Visit/中心筛选访视SMVSite Monitoring Visit/中心监查访视SVRSite Visit Report/中心访视报告SDSource Data/源数据SDVSource Data Verification/原始数据核查SFDAState Food and Drug Administration/国家食品药品监督管理局SICSubject Identification Code/受试者识别代码SIFSite Infor

13、mation Form/中心信息表SIVSite Initiation Visit/中心启动访视SOPStandard Operating Procedure/标准操作规程SOWScope of Work/工作范围Sub-ISubinvestigator次要研究者SUSARSuspected Unexpected Serious Adverse Reaction可疑的非预期的严重不良反应TPTemplate/模版TMFTrial Master File/试验主文档UADRUnexpected Adverse Drug Reaction/非预期药物不良反应UADEUnanticipated ad

14、verse drug effect/非预期的不良反应UAEUnexpected adverse event/非预期的不良事件WIWork Instruction/工作指南SOP 类型缩写表OP 操作规程 Operating ProceduresWI 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 D

15、evelopmentCM 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 Science 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 FileP