临床英语术语缩写表.docx

临床研究常用术语缩写表编号术语缩写英文全称/中文全称ADRAdverse drug reaction/不良反应AEAdverseEvent/不良事件ASVAccompanied Site Visit/陪同访视BD业务拓展Business DevelopmentBS生物统计BiostatisticsCCFCentral Clinical File申办方临床研究文件夹CDControlled Documents/控制文件CDAConfidentiality Disclosure Agreement/保密协议CDCCenter for Disease Control/疾病控制中心CSDsClinicalStudy Documents临床研究文件CECCentral Ethics Committee/中心伦理委员会Co-ICoordinating Investigator负责协调不同中心参加多中心临床试验研究者的研究者COFChange Order Form/工作范围变更申请表CIFCentral Investigator’s File申办者—研究者文件夹（中心研究者文件夹）CMClinical Monitoring / Operations/临床监查/运营CMAClinical Monitoring Associate/临床研究监查助理CRComplete Response痊愈CRAClinical Research Associate (equivalent to Clinical Study Monitor)临床监查员CRCClinical Research Coordinator/临床研究协调员CRFCase Report Form or Case Record Form/病例报告表CROContract Research Organization/合同研究组织CSDsClinical Study Documents/临床研究文件CSRClinical Study Report/临床研究报告CTAClinical Trial Assistant (equivalent to Clinical Research Assistant)临床研究助理CTAClinical Trial Agreement/临床试验协议CTAClinical Trial Application/临床试验申请CTSClinical Trial Supplies/临床试验用品CTXClinical Trial Exemption/临床试验免责CVCurriculum Vitae/履历DCFData Clarification Form /数据澄清表DCRData Clarification Report (see DCF)/数据澄清报告DCRFData Clarification and Resolution Form (see DCF)/数据澄清和解决表DMData Management/数据管理DMPData Management Plan/数据管理计划书DQFData Query Form/数据疑问表DSData Source/数据源ECEthics Committee /伦理委员会eCRFElectronic Case Report Form/电子病历报告表EDCElectronic Data Capture/电子数据采集EOSEnd of Study/研究结束EUEuropean Union/欧盟FASFull Analysis Set/全分析集FDAFood and Drug Administration/美国食品药品管理局FMApprovedStandardForm/批准的标准表格GCPGood Clinical Practice/临床试验质量管理规范GLPGood Laboratory Practice /实验室质量管理规范GMPGood Manufacturing Practice/药品生产质量管理规范GRPGood Research Practice/科学研发质量管理规范GSPGoodStatisticalPractice/统计质量管理规范HCOHead of Clinical Operations临床运营总监IBInvestigators Brochure/研究者手册ICInformed Consent/ 知情同意ICFInformedConsentForm(alsoseeIC)/知情同意书ICHInternational Conference on Harmonization/国际协调会议ICH-GCPInternational Conference on Harmonisation Tripartite Guideline on G