完整版药物临床试验英文缩写120Word格式文档下载.docx

1、计算机辅助试验设计CICo-i nv estigator合作研究者COICoord in ati ng Inv estigator协调研究者CRCCli nical Research Coord in ator临床研究协调者CRFCase report form/ case record form病例报告表/病例记录表CROCon tract Research Orga ni zati on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 Exempt

2、ion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DASDisability assessme nt schedule功能残疾量表DSMBData Safety and mon itor ing Board数据安全及监控委员会ECGElectrocardiogram心电图EDCElectro nic Data Capture电子数据米集系统EDPElectro nic Data Process ing电子数据处理系统EMGElectromyography肌电图仪FASFull an alysis s

3、et全分析集FDAFood and Drug Adm ini strati on美国食品与药品管理局FRFinal Report总结报告GASGlobal Assessme nt Scale总体评估量表GCPGood Cli nical 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 Manu facturi ng Practice药品生产质量管理规范HIT-6Headache Impact Test头痛影响测定问卷IBInvestigator s Brochure研究者手册IBRIn stituti on

4、 review board机构审查委员会ICIn formed Consent知情同意ICFIn formed Consent Form知情同意书ICHIntern ati onal Conference on Harmoni zation国际协调会议IDMIn depe ndent Data Mon itori ng独立数据监察IDMCIndependent Data Monitoring Committee独立数据监察委员会IECIn depe ndent Ethics Committee独立伦理委员会INDInv estigati onal New Drug新药临床研究IRBIn sti

5、tuti onal Review BoardITTInten ti on-to-treat意向性分析（统计学）IVDIn Vitro Diag no stic体外诊断IVRSIn teractive Voice Resp onse System互动语音应答系统IWRSin teractive web resp onse system交互式网络响应系统MAMarketing Approval/Authorization上市许可证MCAMedici nes Con trol Agency英国药品监督局MHWMi nistry of Health and Welfare日本卫生福利部MIDASMig

6、rai ne Disability Assessme nt偏头痛残疾程度评估问卷MSQMigraine-Specific Quality of Life questionra偏头痛特异性生活质量问卷NDANew Drug Applicati on新药申请NECNew Drug En tity新化学实体NIHNatio nal In stitutes of Health国家卫生研究所（美国）PIPrin cipal Inv estigator主要研究者PLProduct Lice nse产品许可证PMAPre-market Approval （Applicati on）上市前许可（申请）PPPe

7、r Protocol符合方案集PSIStatisticians in the Pharmaceutical Industry制药业统计学家协会QAQuality Assura nee质量保证QCQuality Con trol质量控制RARegulatory Authorities监督管理部门SASite Assessme nt现场评估SAESerious Adverse Eve nt严重不良事件SAPStatistical An alysis Pla n统计分析计划SARSerious Adverse Reacti on严重不良反应SDSource Data/Docume nt原始数据/文件

8、Subject Diary受试者日记SFDAState Food and Drug Administration国家食品药品监督管理局SDVSource Data Verificati on原始数据核准SELSubject En rollme nt Log受试者入选表SISub-i nv estigatorSponsor-lnv estigator申办研究者SICSubject Identification Code受试者识别代码SIGNScottish Intercollegiate Guidelines Network苏格兰会际指南网络标准SOPStan dard Operat ing P

9、rocedure标准操作规程SPLStudy Personnel List研究人员名单SSSafety An alysis Set安全分析集SSLSubject Scree ning Log受试者筛选表T&RTest and Refere nee Product受试和参比试剂UAEUn expected Adverse Event预料外不良事件ULNUpper Limit Normal正常值上限WHOWorld Health Orga ni zatio n世界卫生组织WHO-ICDRAWHO Intern ati onal Con fere nee of Drug Regulatory Aut

10、horitiesWHO国际药品管理当局会议无缩略语AApproval批准Audit or in specti on稽查/视察Audit report稽查报告Auditor稽查员BBias偏性/偏倚Bioequivale nee生物等效应Bla nk con trol空白对照Bli nd codes编制盲底Bli nd review盲态审核盲态检杳Bli nding method盲法Bli ndin g/mask ing盲法/设盲CCase history病历Cli nical equivale nee临床等效应Cli ni cal study临床研究Cli nical trial临床试验Com

11、paris on对照Complia nee依从性Composite variable复合变量Con siste ncy test致性检验Con tract/ agreeme nt协议/合同Con trol group对照组Coord in ati ng committee协调委员会DData man ageme nt数据管理Docume ntati on记录/文件Drop out脱落EEffective ness疗效End point终点八、En dpo int Criteria终点指标En dpo int criteria/ measureme ntEquivale nee等效性Esse n

12、tial Docume ntati on必需文件Ethics committee伦理委员会Excelle nt显效Exclusion criteria排除标准FFailure无效/失败Final pointIInclusion Criteria入选表准Inclusion criteria入选标准Information Gathering信息收集In itial meet ing启动会议In specti on检察/视察In stituti on in specti on机构检杳In terim an alysis期中分析Inv estigati onal Product试验药物Inv estigator研究者LLost of follow up失访MMo nitor监察员Mon itori ng监杳Monitoring Plan监察计划Mon itori ng Report监察报告Multi-ce nter Tri