药物临床试验英文缩写汇编(共14页).doc

精选优质文档-----倾情为你奉上药物临床试验英文缩写 序号缩略语中文全称英文全称 1ADE 药物不良事件Adverse Drug Event 2ADR 药物不良反应Adverse Drug Reaction 3AE 不良事件Adverse Event 4AI 助理研究者Assistant Investigator 5BMI 体质指数Body Mass Index 6CI 合作研究者Co-investigator 7COI 协调研究者Coordinating Investigator 8CRC 临床研究协调者 Clinical Research Coordinator 9CRF 病历报告表Case Report Form 10CRO 合同研究组织Contract Research Organization 11CSA 临床研究申请Clinical Study Application 12CTA 临床试验申请Clinical Trial Application 13CTX 临床试验免责Clinical Trial Exemption 14CTP 临床试验方案Clinical Trial Protocol 15CTR 临床试验报告Clinical Trial Report 16DSMB　 数据安全及监控委员会Data Safety and monitoring Board EC伦理委员会EthicsCommittee17EDC 电子数据采集系统Electronic Data Capture 　 18EDP 电子数据处理系统Electronic Data Processing 19FDA 美国食品与药品管理局Food and Drug Administration 20FR 总结报告Final Report 21GCP　　 药物临床试验质量管理规范Good Clinical Practice 22GLP 药物非临床试验质量管理规范Good Laboratory Practice 23GMP 药品生产质量管理规范Good Manufacturing Practice 24IB 研究者手册Investigator’s Brochure 25IC 知情同意Informed Consent 26ICF 知情同意书Informed Consent Form 27ICH 国际协调会议International Conference on Harmonization 28IDM 独立数据监察Independent Data Monitoring 29IDMC 独立数据监察委员会Independent Data Monitoring Committee 30IEC 独立伦理委员会Independent Ethics Committee 31IND　 新药临床研究Investigational New Drug 32IRB 机构审查委员会Institutional Review Board 33IVD 体外诊断In Vitro Diagnostic 34IVRS 互动语音应答系统Interactive Voice Response System 35MA 上市许可证Marketing Approval/Authorization 36MCA 英国药品监督局Medicines Control Agency 37MHW日本卫生福利部Ministry of Health and Welfare 38NDA新药申请New Drug Application 39NEC新化学实体New Drug Entity 40NIH国家卫生研究所（美国）National Institutes of Health 41PI主要研究者Principal Investigator 42PL产品许可证Product License 43PMA上市前许可（申请）Pre-marketApproval(Application) 44PSI制药业统计学家协会Statisticians in the Pharmaceutical Industry 45QA质量保证Quality Assurance 46QC质量控制Quality Control 47RA监督管理部门Regulatory Authorities 48SA现场评估Site Assessment 49SAE严重不良事件Serious Adverse Event 50SAP统计分析计划Statistical Analysis Plan 51SAR严重不良反应Serious Adverse Reaction 52SD原始数据/文件Source Data/Document 53SD受试者日记Subject Diary 54SFDA国家食品药品监督管理局StateFoodandDrugAdministration 55SDV原始数据核准Source Data Verification 56SEL受试者入选表Subject Enrollment Log 57SI助理研究者Sub-investigator 58SI申办研究者Sponsor-Investigator 59SIC受试者识别代码Subject Identification Code 60SOP标准操作规程Standard Operating Procedure 60SPL研究人员名单Study Personnel List 62SSL受试者筛选表Subject Screening Log 63T&R受试和参比试剂Test and Reference Product 64UAE预料外不良事件Unexpected Adverse Event 65WHO世界卫生组织World Health Organization 66WHO-ICDRAWHO国际药品管理当局会议 WHO International Conference of Drug Regulatory Authorities 药物临床试验英文缩写英文全称中文全称Accuracy准确度Active control, AC阳性对照 活性对照Adverse medical events不良医学事件Adverse reaction药物不良反应Alb白蛋白ALD（Approximate Lethal Dose）近似致死剂量ALP碱性磷酸酶Alpha spending function消耗函数ALT丙氨酸氨基转换酶Analysis sets统计分析的数据集Approval批准Assistant investigator助理研究者AST天门冬酸氨基转换酶ATR衰减全反射法AUCss稳态血药浓度－时间曲线下面积Audit 稽查Audit or inspection稽查／视察Audit report 稽查报告Auditor稽查员Bias偏性 偏倚Bioequivalence生物等效应Blank control空白对照Blind codes编制盲底Blind review盲态审核Blind review 盲态检查Blinding method盲法Blinding/masking盲法/设盲Block层Block size每段的长。