临床试验常用的英文缩写

1、_专业术语缩略语 英文全称中文全称ADEAdverse Drug Event药物不良事件ADRAdverse Drug Reaction药物不良反应AEAdverse Event不良事件AIAssistant Investigator助理研究者BMIBody Mass Index体质指数CICo-investigator合作研究者COICoordinating Investigator协调研究者CRAClinical Research Associate临床监查员（临床监察员）CRCClinical Research Coordinator临床研究协调者CRFCase Report Form病

2、历报告表CROContract Research Organization合同研究组织CSAClinical Study Application临床研究申请CTAClinical Trial Application临床试验申请CTXClinical Trial Exemption临床试验免责CTPClinical Trial Protocol临床试验方案CTRClinical Trial Report临床试验报告DSMB Data Safety and monitoring Board数据安全及监控委员会EDCElectronic Data Capture电子数据采集系统精品资料_EDPEle

3、ctronic Data Processing电子数据处理系统FDAFood and Drug Administration美国食品与药品管理局FRFinal Report总结报告GCPGood Clinical Practice药物临床试验质量管理规范GLPGood Laboratory Practice药物非临床试验质量管理规范GMP Good Manufacturing Practice药品生产质量管理规范IBInvestigator s Brochure研究者手册ICInformed Consent知情同意ICFInformed Consent Form知情同意书ICHInternat

4、ional Conference on Harmonization国际协调会议IDMIndependent Data Monitoring独立数据监察IDMCIndependent Data Monitoring Committee独立数据监察委员会IECIndependent Ethics Committee独立伦理委员会INDInvestigational New Drug新药临床研究IRBInstitutional Review Board机构审查委员会IVDIn Vitro Diagnostic体外诊断IVRSInteractive Voice Response System互动语音应

5、答系统MAMarketing Approval/Authorization上市许可证MCAMedicines Control Agency英国药品监督局MHWMinistry of Health and Welfare日本卫生福利部NDANew Drug Application新药申请NECNew Drug Entity新化学实体精品资料_NIHNational Institutes of Health国家卫生研究所（美国）PIPrincipal Investigator主要研究者PLProduct License产品许可证PMAPre-market Approval (Application

6、)上市前许可（申请）PSIStatisticians in the Pharmaceutical Industry制药业统计学家协会QAQuality Assurance质量保证QCQuality Control质量控制RARegulatory Authorities监督管理部门SASite Assessment现场评估SAESerious Adverse Event严重不良事件SAPStatistical Analysis Plan统计分析计划SARSerious Adverse Reaction严重不良反应SDSource Data/Document原始数据 /文件SDSubject Di

7、ary受试者日记SFDAState Food and Drug Administration国家食品药品监督管理局SDVSource Data Verification原始数据核准SELSubject Enrollment Log受试者入选表SISub-investigator助理研究者SISponsor-Investigator申办研究者SICSubject Identification Code受试者识别代码SOPStandard Operating Procedure标准操作规程SPLStudy Personnel List研究人员名单精品资料_SSLSubject Screening

8、Log受试者筛选表T&RTest and Reference Product受试和参比试剂UAEUnexpected Adverse Event预料外不良事件WHOWorld Health Organization世界卫生组织WHO-ICDRA WHO International Conference of Drug Regulatory AuthoritiesWHO 国际药品管理当局会议Active Control阳性对照、活性对照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

9、History病历Clinical study临床研究Clinical Trial临床试验Clinical Trial Report临床试验报告Compliance依从性Coordinating Committee协调委员会Cross-over Study交叉研究Double Blinding双盲Endpoint Criteria/measurement终点指标精品资料_Essential Documentation必需文件Exclusion Criteria排除标准Inclusion Criteria入选表准Information Gathering信息收集Initial Meeting启动

10、会议Inspection检察 /视察Institution Inspection机构检察Investigational Product试验药物Investigator研究者Monitor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P

11、lacebo安慰剂Placebo Control安慰剂对照Preclinical Study临床前研究精品资料_Protocol试验方案Protocol Amendments修正案Randomization随机Reference Product参比制剂Sample Size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Study Site研究中心Subject Screening Log受试者筛选表System Audit系统稽