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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 DevelopmentCM 临床监查/运营Clinical Monitoring/Op
