临床g监查员cra需2要学习的相关名词.docxVIP

临床监察员相关名词缩写语英语全称中文全称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BABioavaliability生物利用度BEBioavaliability生物等效性BMIBody Mass Index体质指数CICo-investigator合作研究者COICoordinating Investigator协调研究员CRAClinical Research Associate临床监察员CRCClinical Research Coordinator临床研究协调员CRFClinical Research Form病例报告表CROContract Research Organization???????? 合同研究组织CSA?Clinical Study Application???临床研究申请CTA?Clinical Trial Application?临床试验申请药物临床试验网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ECEthnics Committee伦理委员会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?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??IB?Investigator’s Brochure???研究者手册ICInformed Consent知情同意ICFInformed Consent Form?知情同意书?ICHInternational Conference on HarmonizationOf Technical Requirements for Registration of pharmaceuticals for Human use国际协调会议?IDM?Independent 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IRB?Institutional 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PKpharmacokinetics药物代谢动力学PMAPre-market Approval (Application)上市前许可（申请）PSIStatisticians in the Pharmaceutical Industry?制药业统计学家协会?QA?Quality Assurance质量保证QCQuality Control质量控制RA?Regulatory Authorities监督管理部门SASite ?Assessment?现场评估SAE?Serious 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SD?Source