1、药物临床试验英文缩写汇编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 Re
2、port 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Ethic
3、sCommittee17EDC 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Inves
4、tigators 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 D
5、rug 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 Enti
6、ty 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
7、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 57S
8、I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 Or
9、ganization 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 set
10、s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每段的长度Carry
11、over effect延滞效应Case history病历Categorical variable分类变量Cav平均浓度CD 圆二色谱CL清除率Clinical equivalence临床等效应Clinical study临床研究Clinical study report临床试验的总结报告Clinical trial临床试验Cmax峰浓度Co-investigator 合作研究者Comparison对照Compliance依从性Composite variable复合变量Computer-assisted trial design CATD计算机辅助试验设计Confidence interva
12、l可信区间Confidence level置信水平Consistency test 一致性检验Contract/ agreement协议合同Control group对照组Coordinating committee 协调委员会Crea肌酐CRF(case report form)病例报告表Crossover design交叉设计Cross-over Study交叉研究Css稳浓度Cure痊愈Data management数据管理Database建立数据库Descriptive statistical analysis描述性统计分析DF波动系统Dichotomies 二分类Diviation
13、偏差Documentation记录文件Dose-reaction relation 剂量反应关系Double dummy双模拟Double dummy technique双盲双模拟技术Drop out 脱落DSC 差示扫描热量计Effectiveness疗效Electronic data capture EDC电子数据采集系统Electronic data processing EDP 电子数据处理系统Emergency envelope应急信件End point终点Endpoint Criteria终点指标Endpoint criteria/ measurement 终点指标Equivale
14、nce 等效性Essential Documentation必需文件Ethics committee 伦理委员会Excellent显效Exclusion criteria排除标准Factorial design析因设计Failure无效 失败Final point终点Fixed-dose procedure固定剂量法Forced titration强制滴定Full analysis set全分析集GCFTIR气相色谱傅利叶红外联用GCMS 气相色谱质谱联用Generic drug 通用名药Global assessment variable全局评价变量GLU 血糖Group sequentia
15、l design成组序贯设计Health economic evaluation, HEV健康经济学评价Hypothesis test假设检验Hypothesis testing假设检验Improvement好转Inclusion criteria 入选标准Information Gathering信息收集Informed consent IC知情同意Initial meeting启动会议Inspection检察/视察Institution inspection 机构检查Institution review board, IBR 机构审查委员会Intention-to treat ITT意向性
16、分析( 统计学)Interactive voice response system IVRS 互动式语音应答系统Interim analysis期中分析International Conference of Harmonization ICH人用药品注册技术要求国际技术协调会 国际协调会议Investigational Product试验药物Investigator研究者Investigators brochure, IB研究者手册Last observation carry forward, LOCF最接近一次观察的结转LCMS 液相色谱质谱联用LD50 板数致死剂量LOCF, Last o
17、bservation carry forward最近一次观察的结转Logic check逻辑检查LOQ (Limit of Quantization)定量限Lost of follow up失访Marketing approval/ authorization上市许可证Matched pair匹配配对Missing value缺失值Mixed effect model混合效应模式Monitor监察员Monitoring监查Monitoring Plan监察计划Monitoring Report监察报告MRT平均滞留时间MS质谱MSMS质谱质谱联用MTD(Maximum Tolerated Do
18、se) 最大耐受剂量Multi-center Trial多中心试验New chemical entity NCE新化学实体New drug application NDA 新药申请NMR 核磁共振谱Non-clinical Study非临床研究Non-inferiority非劣效性Non-parametric statistics 非参数统计方法Obedience依从性ODR 旋光光谱Open-label非盲Optional titration随意滴定Original medical record原始医疗记录Outcome 结果Outcome Assessment结果评价Outcome ass
19、essment结果指标评价Outcome measurement 结果指标Outlier离群值Parallel group design平行组设计Parameter estimation 参数估计Parametric statistics参数统计方法Patient file病人档案Patient history病历Per protocol PP 符合方案集Placebo安慰剂Placebo control安慰剂对照Polytomies多分类Power检验效能Precision精密度Preclinical study临床前研究Primary endpoint主要终点Primary variabl
20、e主要变量Principle investigator PI主要研究者Product license PL产品许可证Protocol试验方案Protocol Amendments修正案Quality assurance QA质量保证Quality assurance unit QAU 质量保证部门Quality control QC质量控制Query list query form 应用疑问表Randomization随机Range check范围检查Rating scale量表Reference Product参比制剂Regulatory authorities RA监督管理部门Replic
21、ation可重复RSD日内和日间相对标准差Run in准备期Safety evaluation安全性评价Safety set安全性评价的数据集Sample size 样本量样本大小Scale of ordered categorical ratings 有序分类指标Secondary variable次要变量Sequence 试验次序Serious adverse event SAE 严重不良事件Serious adverse reaction SAR 严重不良反应Seriousness严重性Severity严重程度Severity 严重程度Significant level检验水准Simpl
22、e Randomization简单随机Single blinding 单盲Site audit 试验机构稽查SOP 试验室的标准操作规程Source data SD原始数据Source data verification SDV原始数据核准Source document SD 原始文件Specificity 特异性Sponsor申办者Sponsor-investigator申办研究者Standard curve标准曲线Standard operating procedure SOP标准操作规程Statistic 统计量Statistical analysis plan统计分析计划Statist
23、ical model统计模型Statistical tables 统计分析表Stratified分层Study Audit研究稽查Study audit 研究稽查Study Site研究中心Subgroup 亚组Sub-investigator 助理研究者Subject受试者Subject受试者Subject diary受试者日记Subject Enrollment受试者入选Subject enrollment log受试者入选表Subject identification code SIC 受试者识别代码Subject Identification Code List受试者识别代码表Subj
24、ect Recruitment受试者招募Subject screening log受试者筛选表Superiority 检验Survival analysis生存分析SXRD单晶X射线衍射System audit系统稽查System Audit系统稽查T1/2消除半衰期Target variable目标变量TBIL总胆红素TCHO总胆固醇Test Product受试制剂TG 热重分析TLC、HPLC制备色谱Tmax 峰时间TP总蛋白Transformation 变量变换Treatment group试验组Trial error 试验误差Trial Initial Meeting试验启动会议Tri
25、al Master File试验总档案Trial objective试验目的Trial site 试验场所Triple blinding三盲Two one-side test 双单侧检验Un-blinding揭盲Unexpected adverse event UAE预料外不良事件UVVIS紫外可见吸收光谱Variability变异Variable变量Visual analogy scale直观类比打分法Visual check人工检查Vulnerable subject弱势受试者Wash-out洗脱Washout period洗脱期 研究者(Investigator),实施临床试验并对临床试验的质量及受试者安全和权益的负责者。研究者必须经过资格审查,具有临床试验的专业特长、资格和能力。协调研究者(CoordinatingInvestigator),在多中心临床试验中负责协调参加各中心研究者工作的一名研究者。申办者(Sponsor),发起一项临
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