临床试验常用的英文缩写

1、百度文库-让每个人平等地提升自我专业术语7Clinical Research Coordinator临床研究协调者Case Report Form病历报告表Contract Research Organization 合同研究组织缩略语英文全称DCF data clarification formSDV source data verificationADE Adverse Drug EventADR Adverse Drug ReactionAEAdverse EventAIAssistant InvestigatorBMI Body Mass IndexCI Co-investigator

2、COI Coordinating InvestigatorCRA Clinical Research AssociateCRCCRFCROCSA Clinical Study ApplicationCTA Clinical Trial ApplicationCTXClinical Trial ExemptionCTPClinical Trial ProtocolCTRClinical Trial Report中文全称数据澄清表，用于纸质 query原始数据核对药物不良事件药物不良反应不良事件助理研究者体质指数合作研究者协调研究者临床监查员（临床监察员）临床研究申请临床试验申请临床试验免责临床试

3、验方案临床试验报告DSMB Data Safety and monitoring Board 数据安全及监控委员会EDC Electronic 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 ReportGCP Good Clinical PracticeGLP Good Laboratory PracticeGMP Good Manufacturing Practice总结报告药物临床试验质量管理规范药物非临床试验质量管理规

4、范药品生产质量管理规范旧 Investigator ' s Brochure 研究者手册IC Informed Consent知情同意ICF Informed Consent Form知情同意书ICH International Conference on Harmonization 国际协调会议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 Investigationa

5、l New Drug新药临床研究IRB Institutional Review Board 机构审查委员会IVD In Vitro Diagnostic体外诊断IVRS Interactive Voice Response System 互动语音应答系统英国药品监督局日本卫生福利部新药申请新化学实体国家卫生研究所（美国）MA Marketing Approval/Authorization 上市许可证MCA Medicines Control AgencyMHW Ministry of Health and WelfareNDANew Drug ApplicationNECNew Drug

6、EntityNIH National Institutes of HealthPI Principal Investigator主要研究者PL Product License产品许可证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State Food and Drug AdministrationRARegulatory Authoritie

7、sSASite AssessmentSAE Serious Adverse EventSAP Statistical Analysis PlanSAR Serious Adverse ReactionSDSource Data/DocumentSDSubject DiarySFDA监督管理部门现场评估严重不良事件统计分析计划严重不良反应原始数据/文件受试者日记国家食品药品监督管理局SDVSource Data VerificationSELSubject Enrollment LogSI Sub-investigatorSI Sponsor-InvestigatorSIC Subject Id

8、entification CodeSOP Standard Operating ProcedureSPL Study Personnel ListSSL Subject Screening LogT&RTest and Reference ProductUAEUnexpected Adverse EventWHO World Health OrganizationWHO-ICDRA管理当局会议原始数据核准受试者入选表助理研究者申办研究者受试者识别代码标准操作规程研究人员名单受试者筛选表受试和参比试剂预料外不良事件世界卫生组织WHO International Conference of

9、 Drug Regulatory Authorities WHO国际药品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 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 Criteri

10、a/measurement终点指标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）Mu

11、lti-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Placebo安慰剂Placebo Control安慰剂对照Preclinical Study怆林刖研究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单旨Sponsor申办者Study AuditSubjectSubject EnrollmentSubject Enrollment LogSubject Identification Code ListSubject RecruitmentStudy SiteSubject Screening LogSystem AuditTest