临床试验常用术语缩写.doc

1、精品文档专业术语缩略语 英文全称 中文全称ADE Adverse Drug Event 药物不良事件ADR Adverse Drug Reaction药物不良反应AE Adverse Event 不良事件AI Assistant Investigator助理研究者BMI Body Mass Index体质指数CI Co-investigator合作研究者COI Coordinating Investigator协调研究者CRA Clinical Research Associate临床监查员 ( 临床监察员 )CRC Clinical Research Coordinator临床研究协调者 C

2、RF Case Report Form病历报告表CRO Contract Research Organization合同研究组织 ECRF电子化病历报告表CSAClinicalStudyApplication临床研究申请CTA ClinicalTrial Application临床试验申请CTX ClinicalTrialExemption临床试验免责CTPClinicalTrialProtocol临床试验方案CTR Clinical Trial Report临床试验报告DSMB Data Safety and monitoring Board数据安全及监控委员会EDC Electronic

3、Data Capture电子数据采集系统EDP Electronic Data Processing电子数据处理系统FDA Food and Drug Administration美国食品与药品管理局FR Final Report总结报告GCP Good Clinical Practice药物临床试验质量管理规范GLP Good Laboratory Practice药物非临床试验质量管理规GMP Good Manufacturing Practice药品生产质量管理规范IB Investigators Brochure研究者手册ICInformed Consent 知情同意ICF Infor

4、med Consent Form知情同意书ECG Electrocardiogram心电图ICH International Conference on Harmonization国际协调会IDM Independent Data Monitoring独立数据监察IDMC Independent Data Monitoring Committee独立数据监察委员会IEC Independent Ethics Committee独立伦理委员会IND Investigational New Drug新药临床研究 IRB Institutional Review Board机构审查委员会IVD In

5、 Vitro Diagnostic体外诊断MA Marketing Approval/Authorization上市许可证IVRS Interactive Voice Response System互动语音应答系统MCA Medicines Control Agency英国药品监督局MHW Ministry of Health and Welfare日本卫生福利部 NDA New Drug Application新药申请NEC New Drug Entity新化学实体 NIH National Institutes of Health国家卫生研究所(美国)PI Principal Invest

6、igator主要研究者PL Product License产品许可证。1 欢迎下载精品文档PMA Pre-market Approval (Application)上市前许可 ( 申请 )PSI Statisticians in the Pharmaceutical Industry制药业统计学家协会QA Quality Assurance质量保证QC Quality Control质量控制RA Regulatory Authorities监督管理部门SA SiteAssessment现场评估SAE Serious Adverse Event严重不良事件SAP Statistical Anal

7、ysis Plan统计分析计划SAR Serious Adverse Reaction严重不良反应SD Source Data/Document原始数据 /文件SD Subject Diary受试者日记Subject identification code (SIC)受试者识别代码SFDA State Food and Drug Administration国家食品药品监督管理局SDV Source Data Verification原始数据核准SEL Subject Enrollment Log受试者入选表SI Sub-investigator助理研究者SISponsor-Investiga

8、tor申办研究者SIC Subject Identification Code受试者识别代码pd pharmacodynamics药物效应动力学SOP Standard Operating Procedure标准操作规程pk pharmacokinetics药物代谢动力学SPL Study Personnel List研究人员名单SSL Subject Screening Log受试者筛选表T&R Test and Reference Product受试和参比试剂UAE Unexpected Adverse Event预料外不良事件WHO World Health Organization世界

9、卫生组织Active Control阳性对照、活性对照WHO-ICDRA WHO International Conference of Drug Regulatory Authorities WHO国际药品 管理当局会议Unexpected adverse event (UAE)预料外不良事件Audit稽查Audit Report稽查报告Auditor稽查员Blank Control空白对照Blinding/masking盲法 /设盲Case History病历Clinical study临床研究ClinicalTrial临床试验ClinicalTrialReport临床试验报告Compli

10、ance依从性Coordinating Committee协调委员会Cross-overStudy交叉研究DoubleBlinding双盲Endpoint Criteria/measurement终点指标Essential Documentation必需文件ExclusionCriteria排除标准InclusionCriteria入选表准InformationGathering信息收集InitialMeeting 启动会议Inspection检察 /视察InstitutionInspection机构检察Investigational Product试验药物Investigator研究者Mon

11、itor监查员 (监察员 )Monitoring 监查 ( 监察 )Monitoring Plan监查计划 ( 监察计划 )Monitoring Report监查报告 ( 监察报告 )Multi-center Trial多中心试验。2 欢迎下载精品文档Non-clinical Study非临床研究Original Medical Record原始医疗记录Outcome Assessment 结果评价Patient File病人档案Patient History病历Placebo安慰剂Placebo Control安慰剂对照Preclinical Study临床前研究Protocol试验方案Pr

12、otocol Amendments修正案Randomization随机Reference Product参比制剂SampleSize样本量、样本大小Seriousness严重性Severity严重程度Single Blinding单盲Sponsor申办者Study Audit研究稽查Subject受试者Subject Enrollment受试者入选Subject Enrollment Log受试者入选表Subject Identification Code List受试者识别代码表 Subject Recruitment受试者招募Subject Screening Log受试者筛选表Syste

13、m Audit系统稽查Study Site研究中心Test Product受试制剂Trial InitialMeeting试验启动会议TrialMasterFile试验总档案Wash-out洗脱Trial Objective试验目的Triple Blinding三盲Wash-out Period洗脱期Alb 白蛋白ALD（ Approximate Lethal Dose）近似致死剂量ALP碱性磷酸酶Alpha spending function消耗函数ALT丙氨酸氨基转换酶Approval批准Analysis sets统计分析的数据集Approval批准ATR衰减全反射法Assistant i

14、nvestigator助理研究者AST天门冬酸氨基转换酶AUCss稳态血药浓度时间曲线下面积Standard operating procedure (SOP)标准操作规程Case report form/ case record form(CRF)病例报告表病例记录表Clinicaltrialapplication (CTA) 临床试验申请Clinicaltrial exemption(CTX)临床试验免责Clinical trial protocol (CTP)临床试验方案Contract research organization (CRO)合同研究组织Computer-assisted

15、 trial design (CATD)计算机辅助试验设计Source data (SD)原始数据Electronic data capture (EDC)电子数据采集系统Source data verification (SDV)原始数据核准Electronic data processing (EDP)电子数据处理系统Subject enrollment log受试者入选表Institution review board (IBR)机构审查委员会Intention-totreat (ITT)意向性分析( 统计学）Interactive voice response system (IVRS)互动式语音应答系统Investigators brochure (I