临床试验以及实验室中常见的中英文名词及缩写.docx

. 中国创新药咨询与服务先锋 CRO 临床试验以及实验室中常见的英文缩写 . . . . . 药物临床试验英文缩写 缩略语ADE ADR AE AI BMI CI COI CRC CRF CRO CSA CTA CTX CTP CTR DSMB EDC EDP FDA FR GCP GCP GMP IB IC ICF ICH IDM IDMC IEC IND IRB IVD IVRS MA MCA MHW NDA NEC NIH 英文全称 Adverse Drug Event Adverse Drug Reaction Adverse Event Assistant Investigator Body Mass Index Co-investigator Coordinating Investigator Clinical Research Coordinator Case Report Form Contract Research Organization Clinical Study Application Clinical Trial Application Clinical Trial Exemption Clinical Trial Protocol Clinical Trial Report Data Safety and monitoring Board Electronic Data Capture Electronic Data Processing Food and Drug Administration Final Report Good Clinical Practice Good Laboratory Practice Good Manufacturing Practice InvestigatorB’roschure Informed Consent Informed Consent Form International Conference on Harmonization Independent Data Monitoring Independent Data Monitoring Committee Independent Ethics Committee Investigational New Drug Institutional Review Board In Vitro Diagnostic Interactive Voice Response System MarketingApproval/Authorization Medicines Control Agency Ministry of Health and Welfare New Drug Application New Drug Entity National Institutes of Health 中文全称 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 临床研究协调者病历报告表 合同研究组织临床研究申请临床试验申请临床试验免责临床试验方案临床试验报告 数据安全及监控委员会电子数据采集系统 电子数据处理系统 美国食品与药品管理局总结报告 药物临床试验质量管理规范 药物非临床试验质量管理规范药品生产质量管理规范 研究者手册知情同意 知情同意书 国际协调会议独立数据监察 独立数据监察委员会独立伦理委员会 新药临床研究 机构审查委员会体外诊断 互动语音应答系统上市许可证 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） 缩略语 PI PL PMA PSI QA QC RA SA SAE SAP SAR SD SD SFDA SDV SEL SI SI SIC SOP SPL SSL TR UAE WHO 英文全称 Principal Investigator Product License Pre-market Approval (Application) Statisticians in the Pharmaceutical Industry Quality Assurance Quality Control RegulatoryAuthorities Site Assessment Serious Adverse Event Statistical Analysis Plan Serious Adverse Reaction Source Data/Document Subject Diary State Food and Drug Administration Source Data Verification Subject Enrollment Log Sub-i