临床研究缩写.docxVIP

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CRCClinical Research Coordinator临床研究协调者CRFCase Report Form病历报告表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DSMBData 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EDPElectronic 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GMPGood Manufacturing Practice药物生产质量管理规范IBInvestigators Brochure研究者手册ICInformed Consent知情同意ICFInformed Consent Form知情同意书ICHInternational 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产品许可证缩略语英文全称中文全称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 Diary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SPLStud