临床英语术语缩写表.doc

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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AEAdverseEvent/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CSDsClinic

2、alStudy 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CRACli

3、nical 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 t

4、o 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 R

5、esolution 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 and

6、Drug Administration/美国食品药品管理局FMApprovedStandardForm/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GSPGoodStatisticalPractice/统计质量管理规范HCOHead of Clinical Operations临床运营总监IBInvestigators Bro

7、chure/研究者手册ICInformed Consent/ 知情同意ICFInformedConsentForm(alsoseeIC)/知情同意书ICHInternational Conference on Harmonization/国际协调会议ICHGCPInternational 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IECIndependent Ethic

8、Committee/独立伦理委员会INDInvestigationalNewDrug(USFDA)/研究用新药IPInvestigationalProduct/研究用产品IRAEsImmediatelyReportableAdverseEvents/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LMLineManager/直线经理LOILettero

9、fIntent/意向书MOHMinistry of Health/卫生部MSAMasterServicesAgreement/主服务协议MTDMaximum Tolerated Dose/最大耐受剂量MWMedicalWriting/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OPOperatingProcedure/操作规程OOSOut

10、 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PINPersonalIdentificationNumber/个人确认密码PKPharmacokinetics/药物代谢动力学PMProjectManager/项目经理PMFProjectManagerment File/项目管理文件夹PMIPeriodic Maintenance Inspection/定期维护检查PMSPostMarket

11、ing Surveillance/上市后药物检测PPProjectPlan/项目计划PPPer Protocol/符合方案集PRPatientRecruitment/患者招募QAQualityAssurance/质量管理QCQualityControl/质量控制RARegulatory Authorities/监督管理部门RMRemote Monitoring/远程监查OnSite Monitoring/现场监查=On-Target Monitoring/目标化监查SAESerious Adverse Event /严重不良事件SCStudy Coordinator/研究协调员SCVSiteC

12、lose-outVisit/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SDSourceData/源数据SDVSourceDataVerification/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SIFSiteInformationForm/中心信息表SIVSiteInitiationVisit/中心启动访

13、视SOPStandardOperatingProcedure/标准操作规程SOWScopeofWork/工作范围Sub-ISubinvestigator次要研究者SUSARSuspectedUnexpectedSeriousAdverseReaction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 adverse drug effect/非预期的不良反应UAEUnexpected adverse event/非

14、预期的不良事件WIWorkInstruction/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/OperationDM 数据管理Data M

15、anagementIT 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 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 FileISF研究者文件夹Investigator Site FileBSF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