医疗器械临研人英文缩写汇总大全
第一部分 临床试验相关英文缩写/短语GCP Good Clinical Practice 医疗器械临床试验质量管理规范CRO Contract Research Organization 合同研究组织CDMO contract development manufacture organization 合同研发生产组织SMO Site Management Organization 现场管理组织CRA Clinical Research Assistant 临床监查员CTA Clinical Trial Assistant 临床试验助理CRC Clinical Research Coordinator 临床协调员IDMC Independent Data Monitoring Committee 独立数据监查委员会DSMB data safety monitoring board 数据安全监查委员会CEC clinical endpoint committee 临床终点判定委员会MAH Marketing Authorization /Approval Holder 上市许可人持有制度RCD random cross-over design 随机交叉设计RCT random control trial 随机对照试验CTX Clinical Trial Exemption 临床试验免责/豁免CDA Confidentiality agreements 保密协议IEC independent ethics committee 独立伦理委员会IRB Institutional Review Board 机构审查委员会ISF investigator study file 研究者文件夹WI work instruction 工作指南SF standard form 标准表格PI Principal Investigator 主要研究者Sub-I sub-Investigator 研究者ICH International Conference Harmonization 该会议由欧盟、美国及日本发起，并由三方成员国的药品管理当局以及制药企业管理机构共同组成。SOP Standard Operation Procedure 临床试验项目标准操作规程GMP Good Manufacturing Practice 药品生产质量管理规范GLP Good Laboratory Practice of drug 药物非临床研究质量管理规范ADR Adverse drug reaction 不良反应AE Adverse Event 不良事件CRF Clinical Research Form病例报告表eCRF Electronic Case Report Form 电子病例报告表，eCRF (EDC系统)ICF Informed Consent Form 知情同意书：是患者表示自愿进行医疗治疗的文件证明。EDP Electronic Data Processing 电子数据处理系统SSU study start up 研究启动前准备工作SEV site evaluation visit 中心评估访视PSV pre-study visit 试验前访视SIV site Initiation visit 中心启动访视RMV routine monitoring visit 常规监查访视COV/SOV close out visit/site close-out visit 中心关闭访视TMF trial master file 临床试验文档研究主文档SDV Source Data Verification 原始数据核查SAE Serious Adverse Event 严重不良事件CTCAE common terminology criteria for adverse events 不良事件通用术语标准IB Investigator’s Brochure 研究者手册IP Investigational Product 研究产品SAP statistical analysis plan 统计分析计划PD protocol deviation 方案偏离PV protocol violation 方案违背SUSAR suspicious unexpected serious adverse reaction 可疑的非预期的严重不良反应CM Concomitant Medications 合并用药MH medical history 既往病史SPL Study Personnel List 研究人员名单SSL Subject Screening Log 受试者筛选表SEL Subject Enrollment Log 受试者入选表BMI body mass index 体重指数PL product license 产品许可证CTD Common Technical Document 通用技术文件On-site training 现场培训Kick-off meeting 启动大会To do list 待办事项清单Follow up letter 跟踪信Vulnerable subjects 弱势受试者Legally Acceptable Representative 法定代理人Study Objective 研究目的Study Endpoint 研究终点Study Design 研究设计Study Procedure 研究流程Study Completion 研究完成Study Termination 研究终止Placebo Control 安慰剂对照Outcome Assessment 结果评价Multi-center Trial 多中心试验Protocol Amendments 修正案Comparator Product 对照产品Subject Identification Code 受试者鉴认代码Essential documents 临床试验必备文件TEAE治疗期不良事件initial Meeting 启动会Subject Identification Code 受试者识别代码FPI/FSI-First Patient/Subject In 首例受试者入组LPI/LSI-Last Patient/Subject In 末例受试者入组LPO/LSO-Last Patient/Subject Out 末例受试者出组Visit Window 访视窗口期Out of Visit Window 超窗Follow Up 随访Wash-out Period 洗脱期Treatment Allocation 治疗分配Patient File 病人档案Case Record/Medical History 病历SD-Source Data/Document/Documentation 原始数据/文件Subject Diary 受试者日记DOB-Date of Birth 出生日期Laboratory Assessment 实验室评估IP-Investigational Product 研究产品CM-Concomitant Medication 合并用药safety Assessment/Evaluation 安全评估Outcome measurement 结果指标primary outcome 主要结果指标secondary outcome 次要结果指标blind review 盲态审核blind codes 盲底blank control 空白对照double blinding 双盲single blinding 单盲treatment group 试验组Un-blinding揭盲Lost follow up 失访documentation control 文件控制double dummy technique 双盲双模拟技术Comparison value 比较值parallel design 平行设计CMDE Center for medical device evaluation 国家药品监督管理局医疗器械技术审评中心IEC International Electrotechnical Commission 国际电子技术委员会MedDRA Medical Dictionary for Regulatory Activities 国际医学用语词典IST industry-sponsored clinical trial 医药企业发起的临床试验IIT Investigator-Initiated Clinical Trial 研究者发起的临床试验WHO World Health Organization 世界卫生组织SOC system organ class 系统器官分类MA Medical Advisor 医学顾问CRP Clinical Research Physician 临床研究医生CDP Clinical Development Plan 临床开发计划GM general manager 总经理CEO chief executive officer 首席执行官VP vice president 副总经理COO chief operations officer 首席运营官FIM First-in-Man 首次人体试验CER clinical evaluation report 临床评价报告CEP clinical evaluation protocol 临床评价方案COC Clinical operation center 临床运营中心BD Business Development 商务发展CO Clinical Operation 临床运营DM Data Management 数据管理MS Medical Service 医学服务RA Regulatory Affairs 注册事务TM Training Management 培训管理OP Operating Procedure 操作规程WI Work Instruction 工作指南SF Standard Form 标准表格BDM Bid Defense Meeting 项目竞标会UDI Unique Device Identification 医疗器械唯一标识IDE Investigational Device exemptions 器械临床豁免USADE非预期的器械SAEASADE预期的器械SAEGAIS面部整体美容改善评分WSRS皱纹严重程度分级评价表Medical Coding 医学编码impartial witness 公平见证人第二部分 合并用药相关缩写Qd--每日一次Bid--每日两次Tid--每日三次Qid--每日四次Qh--每小时1次Biw--每周两次St--立即DC--取消、停止Prn--需要时长期医嘱Sos--需要时限用一次，12小时内有效gtt--滴、量滴、滴剂Mist--合剂Tab--片剂Inj-注射剂Cap--胶囊Uug-软胶膏Ac--餐前Am--上午Pm--下午Qn-每晚Pc--餐后i.H--皮下注射I.m/M--肌肉注射Iv./V--静脉注射lv.gtt--静滴Po--口服Ad us.Int--内服Ad us.Inext--外用Inhal.--吸入
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