-临床英语术语缩写表

1、编号术语缩写adraeasv临床研究常用术语缩写表 英文全称/中文全称adverse drug reaction/不良反应 adverse event/不良事件 accompanied site visit/陪同访视bdbs业务拓展生物统计business developmentbiostatisticsccfcdcdacdccsdscecco-icentral clinical file申办方临床研究文件夹controlled documents/控制文件confidentiality disclosure agreement/保密协议center for disease control/疾

2、病控制中心clinical study documents临床研究文件central ethics committee/中心伦理委员会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cofchange order form/工作范围变更申请表cifcmcmacrcracrccrfcrocsdscsrctactactactsctxcvdcfdcrdcrfdmdmpcentral investigators申file办者研究者文件夹（中心研究者文件夹）clinical monitoring / operations/临床监查/运营clinical

3、 monitoring associate/临床研究监查助理complete response痊愈clinical research associate (equivalent to clinical study monitor) 临床监查员clinical research coordinator/临床研究协调员case report form or case record form/病例报告表contract research organization/合同研究组织clinical study documents/临床研究文件clinical study report/临床研究报告clin

4、ical trial assistant (equivalent to clinical research assistant) 临床研究助理clinical trial agreement/临床试验协议clinical trial application/临床试验申请clinical trial supplies/临床试验用品clinical trial exemption/临床试验免责c urriculum vitae/履历d ata clarification form数据/澄清表data clarification report (see dcf)/数据澄清报告data clarifi

5、cation and resolution form (see dcf)/数据澄清和解决表data management/ 数据管理data management plan/ 数据管理计划书编号术语缩写dqfddeeecrfedceoseufasfdafmgcpglpgmpgrpggghhhibicicfichich-gcpidbiecindipiraesirbittisaisflmlllmmmmsamtdmmnnncencsnd英文全称/中文全称data query form/数据疑问表d ata source/数据源e thics committee 伦/理委员会electronic ca

6、se report form/电子病历报告表electronic data capture/电子数据采集end of study/研究结束e uropean union/欧盟f ull analysis set/全分析集food and drug administration/美国食品药品管理局approved standard form/批准的标准表格good clinical practice/临床试验质量管理规范good laboratory practice实/验室质量管理规范good manufacturing practice/药品生产质量管理规范good research pra

7、ctice/科学研发质量管理规范g ood statistical practice/统计质量管理规范h ead of clinical operations临床运营总监i nvestigators brochure/研究者手册informed consent/ 知情同意informed consent form (also see ic)/知情同意书international conference on harmonization/国际协调会议 international conference on harmonisation tripartite guideline on good cli

8、nical practice国际协调会议药品临床试验质量管理规范指南investigational drug brochure试验/药物手册independent ethic committee/独立伦理委员会investigational new drug (us fda)/研究用新药investigational product/研究用产品immediately reportable adverse events/立即上报的不良事件 institutional review board.机构/审查委员会intention to treat/意向性治疗investigator study a

9、greement/研究者合同investigational site file研究者文件夹line manager/直线经理l etter of intent/意向书m inistry of health/卫生部master services agreement/主服务协议maximum tolerated dose/ 最大耐受剂量m edical writing/医学写作n ot available/不可用new chemical entity/新化学实体not clinically significant/无临床意义not done/未做编号术语缩写ndaodopoososotlpdpip

10、inpkpmpmfpmipmsppppppqqqqrrrmsaescscvssvsmvsvrsdsdvsfdasicsifsivsopsowsub-isusartptmfuadr英文全称/中文全称n ew drug application./新药上市申请o ther documents/ 其他文件operating procedure/操作规程out of scope/超工作范围overall survival/总体生存期o perational team lead/运营团队负责人p rotocol deviation/方案偏离principle investigator /主要研究者pers

11、onal identification number/个人确认密码 pharmacokinetics/药物代谢动力学project manager/项目经理project managerment file/项目管理文件夹periodic maintenance inspection/定期维护检查 post-marketing surveillance/上市后药物检测project plan/项目计划per protocol/符合方案集p atient recruitment/ 患者招募q uality assurance/质量管理q uality control/质量控制r egulatory

12、 authorities/监督管理部门remote monitoring/远程监查on-site monitoring/现场监查=on-target monitoring/目标化监查 serious adverse event /严重不良事件study coordinator/研究协调员site close-out visit/中心关闭访视site selection visit/中心筛选访视site monitoring visit/中心监查访视site visit report/中心访视报告source data/源数据source data verification/原始数据核查stat

13、e food and drug administration/国家食品药品监督管理局 subject identification code/受试者识别代码site information form/中心信息表site initiation visit/中心启动访视standard operating procedure/标准操作规程scope of work/工作范围subinvestigator次要研究者suspected unexpected serious adverse reaction可疑的非预期的严重不良反应template/模版t rial master file/试验主文档u

14、 nexpected adverse drug reaction/非预期药物不良反应编号术语缩写uadeuaewi英文全称/中文全称unanticipated adverse drug effect/非预期的不良反应 unexpected adverse event/非预期的不良事件work instruction/工作指南sop 类型缩写表op 操作规程 wi 工作指南operating procedureswork 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/

15、 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 science servicepm 项目管理 qa 质量保证 rm 记录管理p roject managementq uality assurancer ecords 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