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 Eve nt药物不良事件ADRAdverse Drug React ion药物不良反应AEAdverse Event不良事件AIAssista nt In vestigator助理研究者BMIBody Mass In dex体质指数CICo-i nvestigator合作研究者COICoordin at ing In vestigator协调研究者CRACli ni cal Research Associate临床监查员（临床监察员）CRCCli nical Research Coordi nator临床研究协调者CRFCase R

2、eport Form病历报告表CROContract Research Organi zati on合同研究组织CSA Clinical Study Application临床研究申请CTAClinical Trial Application临床试验申请CTXCli nical Trial Exempti on临床试验免责CTPCli nical Trial Protocol临床试验方案CTRCli nical Trial Report临床试验报告DSMB Data Safety and monitoring Board数据安全及监控委员会EDCElectro nic Data Capture

3、电子数据采集系统EDP Electronic Data Processing电子数据处理系统FDA Food and Drug Admi nistratio n美国食品与药品管理局FR Final ReportGCP Good Clinical PracticeGLP Good Laboratory PracticeGMP Good Manufacturing PracticeIBIn vestigator ' BrochureICIn formed ConsentICFIn formed Consent FormICHIntern ati onal Conference on Har

4、moni zati onIDMIn depe ndent Data Mon itori ngIDMC In depe nde nt Data Mon itori ng CommitteeIECIn depe ndent Ethics CommitteeINDIn vestigati onal New DrugIRBIn stitutio nal Review BoardIVD In Vitro Diag no stic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

5、审查委员会体外诊断IVRSIn teractive Voice Respo nse System互动语音应答系统MAMarketi ng Approval/Authorizatio n上市许可证MCAMedici nes Co ntrol Age ncy英国药品监督局MHWMi nistry of Health and Welfare日本卫生福利部NDANew Drug Applicati on新药申请NEC New Drug En tity新化学实体PMA Pre-market Approval (Applicati on)PSIStatisticia ns in the Pharmaceu

6、tical In dustryQAQuality Assura neeQCQuality Con trolRARegulatory AuthoritiesSASite Assessme ntState Food and Drug Admi nistratio nNIH Natio nal In stitutes of HealthPI Prin cipal In vestigatorPL Product Lice nseSAE Serious Adverse EventSAPStatistical An alysis Pla nSARSerious Adverse React ionSDSou

7、rce Data/Docume ntSDSubject DiarySFDASDVSource Data Verificati onSELSubject En rollme nt LogSI Sub-i nvestigatorSISponsor-In vestigatorSICSubject Ide ntificatio nCodeSOPStan dard Operati ngProcedureSPLStudy Perso nnel List国家卫生研究所（美国）主要研究者产品许可证上市前许可（申请）制药业统计学家协会质量保证质量控制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

8、据/文件受试者日记国家食品药品监督管理局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SSLSubject Scree ning Log受试者帅选表T&RTest and Refere nee Product受试和参比试剂UAEUn expected Adverse Event预料外不良事件WHOWorld Health Orga ni zati on世界卫生组织WHO-ICDRA WHO In ternatio nal Conference of Drug Regulatory Authorities国际药品管理当局会议WHOActive Co n

9、trol阳性对照、活性对照Audit稽查Audit Report稽查报告Auditor稽查员Bla nk Co ntrol空白对照Bli ndin g/mask ing盲法/设盲Case History病历Cli nical study临床研究Cli nical Trial临床试验Cli nical Trial Report临床试验报告Complia nee依从性Coordin at ing Committee协调委员会Cross-over Study交叉研究Double Bli nding双盲En dpo int Criteria/measureme nt终点指标Esse ntial Doc

10、ume ntati onExclusion CriteriaIn clusi on CriteriaInformation GatheringIni tial Meet ingIn spect ionIn stituti on In specti onIn vestigati onal ProductIn vestigatorMon itorMon itori ngMon itori ng Pla nMon itori ng ReportMulti-ce nter TrialNon-clinical StudyOrigi nal Medical RecordOutcome Assessme n

11、tPatient FilePatie nt HistoryPlaceboPlacebo Con trolPreclinical Study必需文件排除标准入选表准信息收集启动会议检察/视察机构检察试验药物研究者监查员（监察员）监查（监察）监查计划（监察计划）监查报告（监察报告）多中心试验非临床研究原始医疗记录结果评价病人档案病历安慰剂安慰剂对照临床前研究Protocol试验方案Protocol Ame ndme nts修正案Ran domizati on随机Refere nee Product参比制剂Sample Size样本量、样本大小Serious ness严重性Severity严重程度Si ngle Bli nding单盲Sponsor申办者Study Audit研究稽查Subject受试者Subject En rollme nt受试者入选Subject En rollme nt Log受试者入选表Subject Identification Code List受试者识别代码表Subject Recruitme nt受试者招募Study Site研究中心Subject Sc