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/ 不良反响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/ 限制文件CDAConfidentiality Disclosure Agreement/保密协议CDCCenter for Disease Control/ 疾病限制中央CS

2、DsClinical Study Documents临床研究文件CECCentral Ethics Committee/中央伦理委员会Co-ICoordinating Investigator负责协调不同中央参加多中央临床试验研究者的研究者COFChange Order Form/ 工作氾围变更申请表CIFCe ntral Investigator研明者 研允者文件夹中央研允者文件失CMClinical Monitoring / Operations/临床监查 /返宫CMAClinical Monitoring Associate/ 临床研究监查助理CRComplete Response 痊愈

3、CRAClinical Research Associate (equivalent to Clinical Study Monitor)临床监查员CRCCRFClinical Research Coordinator/临床研究协调员Case Report Form or Case Record Form/ 病例报CROContract Research Organization/合 1 司研究组织CSDsClinical Study Documents/临床研究文件CSRClinical Study Report/ 临床研究报告CTAClinical Trial Assistant (equ

4、ivalent 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 Clar

5、ification and Resolution Form (see DCF)/数据澄清和解决表DMData Management/ 数据治理DMPData Management Plan/ 数据治理方案书编号术语缩写央文全称/中文全称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/电子数据米集EOSEnd of Study/研究结束EUEuropean Union/ 欧盟FA

6、SFull Analysis Set/ 全分析集FDAFood and Drug Administration/美国食品药品治理局FMApproved Standard Form/ 批准的标准表格GCPGood Clinical Practice/临床试验质量治理规也GLPGood Laboratory Practice / 头验至质量治理规也GMPGood Manufacturing Practice/药品生产质量治理规也GRPGood Research Practice/ 科学研发质量治理规也GSPGood Statistical Practice/统计质量治理规也HCOHead of C

7、linical Operations临床返宫忌监IBInvestigators Brochure/ 研允者手册ICInformed Consent/ 知情同意ICFInformed Consent Form (also see IC)/知情同息书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治理标准指南IDBInvestig

8、ational Drug Brochure / 试验药物IECIndependent Ethic Committee/独立伦理委员会INDInvestigational New Drug (US FDA)/研先用新药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/ 后向性治疗ISAInvestigator Study Agreement/ 研究者合同IS

9、FInvestigational Site File 研允者文件夹LMLine Manager/直线经理LOILetter of Intent/ 息向书MOHMinistry of Health/ 卫生部MSAMaster Services Agreement/ 主效劳协议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/无临床急义NDNot Done/ 未做编号术语缩写央文全

10、称/中文全称NDANew Drug Application./ 新药上市申请ODOther Documents/ 其他文件OPOperating Procedure/ 操作规程OOSOut Of Scope/超工作范围OSOverall Survival/ 总体生存期OTLOperational Team Lead/ 运宫 团队: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

11、Manager/ 工程经理PMFProject Managerment File/ 工程治理文件夹PMIPeriodic Maintenance Inspection/ 定期维护检查PMSPost-Marketing Surveillance/上市后药物检测PPProject Plan/工程方案PPPer Protocol/符合方案集PRPatient Recruitment/招募QAQuality Assurance/ 质量治理QCQuality Control/ 质量限制RARegulatory Authorities/ 监督治理部门RMRemote Monitoring/ 远程监查On-

12、Site 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SCVSite Close-out Visit/ 中央关闭访视SSVSite Selection Visit/ 中央筛选访视SMVSite Monitoring Visit/ 中央监查访视SVRSite Visit Report/中央访视报告SDSource Data/ 源数据SDVSource Data Verification/ 原始数据核查SFDAState Food and

13、Drug Administration/国家食品药品监督治理局SICSubject Identification Code/ 受试者识别代码SIFSite Information Form/ 中央信息表SIVSite Initiation Visit/ 中央启动访视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/、良反响TPTemplate/ 模版TMFT

14、rial Master File/ 试验主文档UADRUnexpected Adverse Drug Reaction/非预期药物不良反响编号I术语缩写央文全称/中文全称UADEUnanticipated adverse drug effect/ 非预期的不良反响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 Form

15、sOD 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 数据治理 Data ManagementIT 信息技术 Information TechnologyMS 医学科学效劳 Medical Science ServicePM 工程治理 Project ManagementQA 质量保证 Quality AssuranceRM 记录治理 Records ManagementRA 注册事务 Regulatory AffairsSM SOP 治理 SOP ManagementST研究中央治理效劳 Site Management ServiceTR 培训I Trainin