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 nical 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 Re

2、port Form病历报告表CROContract Research Organi zatio n合同研究组织CSACli ni cal Study Applicati on临床研究申请CTAClinical Trial Application临床试验申请CTXClinical Trial Exemption临床试验免责CTPCli nical 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EDCElectro nic Data Capture电子

3、数据采集系统EDP Electr onic Data Process ing电子数据处理系统美国食品与药品管理局FDA Food and Drug Admi nistratio nFR Fi nal ReportGCP Good Clinical Practice总结报告药物临床试验质量管理规范GLP Good Laboratory Practice药物非临床试验质量管理规范GMP Good Manufacturing PracticeIBInvestigator BrochureICIn formed Consent药品生产质量管理规范研究者手册知情同意ICF In formed Conse

4、nt Form知情同意书ICHIntern ati onal Conference on Harmoni zati on国际协调会议IDMIn depe ndent Data Mon itori ng独立数据监察IDMCIn depe nde nt Data Mon itori ng Committee独立数据监察委员会IECIn depe ndent Ethics Committee独立伦理委员会INDIn vestigati onal New Drug新药临床研究IRB In stitutio nal Review Board机构审查委员会IVD In Vitro Diag nostic体

5、外诊断IVRSIn teractive Voice Respo nse System互动语音应答系统MAMarket ing Approval/Authorizati on上市许可证MCA Medi cines Control Age ncyMHW Mi nistry of Health and WelfareNDANew Drug Applicatio nNECNew Drug En tity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）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

6、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PLProduct Lice nseNIHNatio nal In stitutes of HealthPIPrin cipal In vestigatorPMA Pre-market Approval (Applicatio n)PSIStatisticia ns in the Pharmaceutical In dustryQAQuality Assura neeQCQuality Con trolRARegulatory AuthoritiesSASite Asses

7、sme ntSAE Serious Adverse Eve ntSAPStatistical An alysis Pla nSARSerious Adverse Reacti onSDSource Data/Docume ntSDSubject DiaryState Food and Drug Admi nistratio nSFDASDV Source Data Verificati onSELSubject En rollme nt LogSI Sub-i nvestigatorSISponsor-In vestigatorSICSubject Ide ntificati onCodeSO

8、PStan dard Operati ngProcedureSPLStudy Perso nnel ListWHO国际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 zatio n世界卫生组织WHO-ICDRA WHO In ternatio nal Conference of Drug Regulatory Authorities药品管理当局会议Active Co ntrol阳性对照、活性

9、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终点指标必需文件Esse ntial Docume nta

10、ti onExclusion Criteria排除标准Inclusion Criteria入选表准Information Gathering信息收集Ini tial Meet ing启动会议In spect ion检察/视察In stituti on In specti on机构检察In vestigati onal Product试验药物In vestigator研究者Mo nitor监查员（监察员）Mon itori ng监杳（监察）Mon itori ng Pla n监查计划（监察计划）Mon itori ng Report监查报告（监察报告）Multi-ce nter Trial多中心

11、试验Non-clinical Study非临床研究Origi nal Medical Record原始医疗记录Outcome Assessme nt结果评价Patient File病人档案Patie nt History病历Placebo安慰剂Placebo Con trol安慰剂对照Preclinical Study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 Scree ning Log受试者帅