临床试验术语英汉对照
常用医学标准的中英文术语翻译
常用医学标准的中英文术语翻译医学标准术语的翻译对于医学界的交流和研究至关重要。
准确地翻译这些术语可以避免误解和混淆，确保专业信息的传递准确无误。
以下是一些常见的医学标准术语的中英文翻译。
1. 临床试验 - Clinical Trial临床试验是一种为了评估新型药物、治疗方法或医疗器械而进行的研究。
这些试验通常包括对人体进行的细致观察和数据收集，以确定疗效和安全性。
2. 疫苗接种 - Vaccination疫苗接种是指通过注射、口服等方式给予人体疫苗，从而提高人体免疫系统对某种疾病的抵抗力。
3. 随机对照试验 - Randomized Controlled Trial (RCT)随机对照试验是一种实验设计，将受试者随机分配到接受不同处理或对照组的不同条件下观察疗效。
4. 细胞培养 - Cell Culture细胞培养是指在实验室中人工创造一种类似于体内环境的培养条件，以培养和研究生物体的细胞。
5. 模拟人体实验 - In Vivo Experiment模拟人体实验是指在活体动物身上进行的实验，以评估药物、治疗方法或其他治疗干预措施的疗效和安全性。
6. 病理研究 - Pathological Research病理研究是通过对病理标本进行组织学、细胞学或分子学等分析，以诊断和研究疾病的方法。
7. 累及人数 - Incidence累及人数是指在一定时间内发生某种疾病或事件的数量，通常以每一万或每一百万人为单位。
8. 重大不良事件 - Adverse Event (AE)重大不良事件是指与药物治疗或其他干预措施相关的严重不良反应或意外事件，可能导致严重的身体伤害甚至死亡。
9. 生物等效性 - Bioequivalence生物等效性是指在给予相同剂量的药物后，在体内的吸收、分布、代谢和排泄等动力学过程中的相似性。
10. 患病率 - Prevalence患病率是指某一特定人群中患有某种疾病的比例或频率，通常以百分比表示。
临床试验相关词汇中英对照
临床试验词汇中英文对照Accuracy 准确度Active control，AC 阳性对照，活性对照Adverse drug reaction，ADR 药物不良反应Adverse event，AE 不良事件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 分段Block 层Block size 每段的长度BUN 尿素氮Carryover effect 延滞效应Case history 病历Case report form 病例报告表Case report form/ case record form，CRF 病例报告表，病例记录表Categorical variable 分类变量Cav 平均浓度CD 圆二色谱CL（clearance）清除率Clinical equivalence 临床等效性Clinical study 临床研究Clinical study report 临床试验的总结报告Clinical trial 临床试验Clinical trial application，CTA 临床试验申请Clinical trial exemption，CTX 临床试验免责Clinical trial protocol，CTP 临床试验方案Clinical trial/ study report 临床试验报告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 interval 可信区间Confidence level 置信水平Consistency test 一致性检验Contract research organization，CRO 合同研究组织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 稳态浓度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 偏差Documentation 记录／文件Dose-reaction relation 剂量－反应关系Double blinding 双盲Double dummy 双模拟Double dummy technique 双盲双模拟技术Double-blinding 双盲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/ measurement 终点指标Equivalence 等效性Essential documentation 必须文件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GC－FTIR 气相色谱－傅利叶红外联用GC－MS 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Good clinical practice，GCP 药物临床试验质量管理规范Good manufacture practice，GMP 药品生产质量管理规范Good non-clinical laboratory practice，GLP 药物非临床研究质量管理规范Group sequential 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Improvement 好转Inclusion criteria 入选标准Independent ethics committee，IEC 独立伦理委员会Information consent form，ICF 知情同意书Information gathering 信息收集Informed consent，IC 知情同意Initial meeting 启动会议Inspection 视察／检查Institution inspection 机构检查Institution review board，IBR 机构审查委员会Intention to treat 意向治疗（——临床领域）Intention-to –treat，ITT 意向性分析（－统计学）Interactive voice response system，IVRS 互动式语音应答系统Interim analysis 期中分析Investigator 研究者Investigator's brochure，IB 研究者手册IR 红外吸收光谱Ka 吸收速率常Last observation carry forward，LOCF 最接近一次观察的结转LC－MS 液相色谱－质谱联用LD50 板数致死剂量Logic check 逻辑检查LOQ （Limit of Quantitation）定量限LOCF，Last observation carry forward 最近一次观察的结转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 监查员Monitoring 监查Monitoring report 监查报告MRT 平均滞留时间MS 质谱MS－MS 质谱－质谱联用MTD（Maximum Tolerated Dose）最大耐受剂量Multicenter trial 多中心试验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-blinding 非盲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 variable 主要变量Principal investigator 主要研究者Principle investigator，PI 主要研究者Product license，PL 产品许可证Protocol 试验方案Protocol 试验方案Protocol amendment 方案补正Quality assurance unit，QAU 质量保证部门Quality assurance，QA 质量保证Quality control，QC 质量控制Query list，query form 应用疑问表Randomization 随机化Randomization 随机Range check 范围检查Rating scale 量表Regulatory authorities，RA 监督管理部门Replication 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 样本含量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Significant level 检验水准Simple randomization 简单随机Single blinding 单盲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 verification，SDV 原始数据核准Source data，SD 原始数据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Statistical analysis plan 统计参数计划书Statistical analysis plan，SAP 统计分析计划Statistical model 统计模型Statistical tables 统计分析表Stratified 分层Study audit 研究稽查Subgroup 亚组Sub-investigator 助理研究者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 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T1/2 消除半衰期Target variable 目标变量T－BIL 总胆红素T－CHO 总胆固醇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 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Unblinding 揭盲Unblinding 破盲Unexpected adverse event，UAE 预料外不良事件UV－VIS 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 清洗期Washout period 洗脱期Well-being 福利，健康临床采血相关词汇Intravenous injection(IV) 静脉注射Intravenous drip/Intravenously guttae(iv gtt)静脉滴注intramscular injection(IM) 肌内注射intradermal injections 皮内注射subcutaneous injections（SC）皮下注射disposable sterile injector 一次性无菌注射针injection set注射器disposable venous infusion needle一次性静脉输液针disposable infusion set 一次性使用输液器blood transfusion set输血器infusion bag液袋urine drainage bag集尿袋blood bag血袋medical catheter医用导管stainless steel needle不锈钢医用针管blood taking needle/ blood collection needle采血针Needle Holder 持针器Blood samples血样样本sample drawing/collection 采血/抽血needles 针vacutainer needles真空采血针tubes导管vacutainer tubes 真空管vacutainer holder 真空持针器tourniquet 止血带disinfection swabs 消毒海绵micropore tapedental rollsadhesive dressing 胶布敷料rubber gloves 橡皮手套pillow 枕头stopper 塞子（采血管的塞子）vacuum tubes真空管non-vacuum tubes 非真空管needle disposal box 穿刺针处理盒（利器处理盒）transfer and storage tubes 转移和存储管pipette 吸管吸液管移液管disposable pipettes一次性使用吸管centrifuge离心机swinging bucket rotor 浮桶式转头、吊桶式转头timer 计时器racks for tubes 试管架identification codes识别码mark/label the tubes标记导管freeze冷冻refrigerator 冰箱freezer 冰箱冷冻机Serum Separation Tube 血清分离试管Serum血清Plasma血浆whole blood 全血be inverted 倒垂的倒置的clot 凝块凝结Coagulate 凝固凝结clotting time 凝血时间minimally 最低限度地最低程度地maximally 最高限度地最高程度地Separation of serum or plasma 分离血清或血浆Hemolysis 溶血hemolyzed samples 溶血样本assays 含量测定analysis 分析（名词）analyze 分析（动词）analyzing 分析（动名词）non-frozen samples 非冷冻样本chemistry laboratories化学实验室Analytical procedures 分析程序Qualification 资质资格Personnel in the laboratory 实验室人员Field personnel 现场工作人员Internal quality control 内部质量控制External quality control 外部质量控制Hepatitis B 乙肝Hepatitis C 丙肝Positive 阳性Negative 阴性Measurement 测量pulse rate 脉搏Blood pressure 血压systolic blood pressure 收缩压diastolic blood pressure 舒张压hypertensives 高血压hypotension 低血压antihypertensive drug 抗高血压药mercury sphygmomanometer 水银式血压计mercury column 水银柱serum total cholesterol 血清总胆固醇lipid lowering drug 降脂药Obesity 肥胖症Blood Glucose 血糖BMI (body mass index) 体重指数Overweight 超重sample size 样本大小statistically 统计上地，统计地statistical precision 统计精度sub-groups亚群Recruitment招募Ethical 伦理的道德的Legal 法律的合法的Data in electronic format 电子版数据back-up data 备查资料常用临床医学英文术语cough 咳嗽asthma 哮喘pneumonia 肺炎heart disease 心脏病arrhythmia 心律不齐indigestion 消化不良gastritis 胃炎appendicitis 盲肠炎hepatitis 肝炎dermatitis皮炎freckle/ephelis 痣，雀斑acne 粉刺flu 流感diarrhoea 痢疾quarantine 检疫vaccinate 打疫苗endemic 水土不服relapse 复发症casualty急症stupor 昏迷sprain 扭伤scalding 烫伤graze 擦伤scratch 搔挠trauma 外伤bruise 淤伤fracture骨折dislocation 脱臼tinnitus耳鸣trachoma沙眼colour blindness 色盲nearsightedness/myopia近视astigmatism 散光gingivitis 牙龈炎cavity 龋齿fever 发烧discomfort/disorder 不适malnutrition 营养不良incubation 潜伏期asthenia 虚弱poisoning 中毒fatigue 疲劳heat stroke 中暑itching 发痒ache/pain 痛tetanus 破伤风night sweat 盗汗chill 打冷颤pale 脸色发白shuddering 发抖inflammation 炎症acute 急症chronic 慢性病congenital 先天性病nausea恶心vomit 呕吐diseases 疾病acute diseases 急性病advanced diseases 病沉重期，晚期疾病chronic diseases慢性病communicable diseases 传染病complicating diseases 并发病congenital diseases 先天性疾病acquired diseases 后天性疾病contagious diseases接触性传染病endemic diseases 地方病epidemic diseases 流行病functional diseases 机能病、官能病infectious diseases 传染病inherited diseases 遗传病malignant diseases恶性病nutritional diseases 营养病occupation diseases 职业病organic diseases 器质性病paroxysmal diseases 阵发性病periodical diseases 周期病primary（principal）diseases原发（主导）病secondary diseases 继发病sexual（venereal, social）diseases 性病terminal diseases 绝症wasting diseases 消耗性疾病chief complaint 主诉clinical manifestation 临床表现delivery history 分娩史etiology病因学family history 家族史history, medical history 病史precipitating（induced）诱因marital status婚姻状况menstrual history 月经史menarche 初潮menopause闭经past history既往史pathogenesis 发病机制personal history 个人史symptoms 症状cardinal symptom 主要症状classical symptom 典型症状concomitant symptom 伴发症状constitutional（systemic）symptom 全身症状indirect symptom 间接症状induced symptom 诱发症状local symptom 局部症状mental symptom精神症状symptom-complex （syndrome）symptom 综合症，症候群signs体征antecedent 前驱征assident （accessory）副征commemorative 后遗症sign of death 死征diagnostic诊断征sign of disease 病征subjective 自觉征，主观征vein sign静脉征vital sign 生命体征body length （height of the body）身高body weight 体重barrel chest 桶状胸cachexia 恶病质compulsive position 被动体位critical facies 病危面容emaciation 消瘦enophthalmos 眼球下陷entropion 睑内翻exophthalmos 眼球突出flushed face 面色潮红gain （loss）in weight 增加（减轻）体重lock-jaw 牙关紧闭lordosis 脊柱前凸nasal ala flap 鼻翼扇动nystagmus 眼震obesity 肥胖pallor 苍白scolisis 脊柱侧凸agitation 焦急不安debility, weakness 虚弱diaphoresis 出汗，大量出汗dizziness, vertigo 眩晕lassitude, fatigue 无力，倦怠malaise 不适night sweat 盗汗numbness 麻木rigor, chill 寒冷，发冷perspiration, sweating 出汗pruritus, itching 痒，somasthenia 躯体无力tingling 麻刺感abscess 脓肿acidosis 酸中毒adhesion 粘连alkalosis 碱中毒allergy 过敏coagulation defect 凝血不良congestion 充血dehydration 脱水distention 膨胀edema 水肿embolism 栓塞，栓塞形成fluid and electrolyte imbalance 水电解质紊乱gangrene 坏疽hematoma 血肿hemorrhage, bleeding 出血infarction 梗塞，梗死infection 传染inflammation 炎症ketoacidosis 酮酸中毒metastasis 转移perforation 穿孔necrosis 坏死shock 休克response 反应，应答reaction 反应，感应thrombosis 血栓形成ulceration 溃疡fever, pyrexia 发烧，发热continuous fever 稽留热intermittent fever 间歇热low-grade fever 低热remittent fever 驰张热relapsing fever 回归热pain 痛burning pain 灼痛chest（flank,…）pain 胸（胁腹…）痛cramp-like pain 痉挛性痛dull, diffused pain 弥漫性钝痛pleuritic pain 胸膜炎性痛radiating pain （pain radiating to…）放射性痛（放射到…疼痛）angina 绞痛cardiac angina 心绞痛backache 背痛colic 绞痛，急腹痛earache 耳痛headache 头痛neuralgia 神经痛migraine 偏头痛rebound tenderness 反跳痛somatalgia 躯体痛sore throat 咽喉痛stomachache 胃痛toothache 牙痛bloody sputum 带血的痰cough 咳嗽dry cough 干咳expectoration 咳痰expectoration of blood 咳血hemoptysis 咳血anoxia 缺氧apnea 呼吸暂停，窒息asthma 气喘，哮喘Cheyne Stokes respiration 切－斯氏呼吸，潮式呼吸dyspnea 呼吸困难hyperpnea hyperventilation 过度呼吸，换气过度hypopnea 呼吸不全，呼吸浅表hypoxia 低氧，缺氧orthopnea 端坐呼吸respiratory arrest 呼吸停止suffocation 窒息tachypnea 呼吸急促fetid breath 口臭fruity breath 呼吸有水果味arrhythmia 心律失常，心律不齐atelectasis 肺不张，肺膨胀不全cardiac arrest 心搏骤停cardiac hypertrophy 心脏肥大cyanosis 发绀，青紫distension of jugular vein 颈静脉怒张extrasystole 期外收缩gallop rhythm 奔马律hemopleura 血胸hepatojugular reflux 肝颈静脉回流hypovolemia （循环）血容量减少palpitation 心悸tachycardia 心动过速pneumothorax 气胸thrill 震颤absent breath sounds 呼吸音消失dull sound 浊音hyperresonant 鼓音rale 啰音rhonchus, rhonchi 鼾音，干啰音wheeze 哮鸣音anorexia, loss of appetite 食欲不振，厌食dysphagia 吞咽困难eructation 嗳气belching 嗳气flatulence 气胀flatus 肠胃气，屁gaseous distention 胃胀气hematemesis 呕血hiccough, hiccup 打呃，呃逆nausea 恶心pyrosis 胃灼热regurgitation 反胃，回流thirsty 口渴vomiting 呕吐anal fissure, crack in the anal canal 肛裂ascites 腹水board-like rigidity of the abdomen 板状腹decreased tactile fremitus 触觉性震颤减弱exophageal varices 食管静脉曲张fistula 瘘，瘘管hemorrhoid 痔hernia 疝hepatomegaly 肝肿大intussusception 肠套叠jaundice 黄疸muscle guarding, defence of the abdominal wall 腹壁肌卫peristalsis 蠕动loss of peristalsis 蠕动消失mass peristalsis 总蠕动retrograde （reversed）peristalsis 逆蠕动prolapse 脱垂prolapse of anus 脱肛rectal prolapse 直肠脱垂，脱肛volvulus 肠扭转calculus 结石，石biliary calculus 胆结石vesical calculus 膀胱结石constipation 便秘defecation 排便diarrhea 腹泻incontinence of feces 大便失禁hematochezia 便血fecal impaction 大便嵌塞occult blood 潜血painful straining with defecation 排便痛性牵动clay colored stools 陶土色便dark, granular/coffee ground emesis 咖啡样呕吐物fecal vomiting, stercoraceous vomiting 呕粪，吐粪foul fatty stools, steatorrhea 恶臭脂肪便，脂肪痢scanty and hard stools 便少而硬tarry （black）stools 柏油样便anuria 无尿burning sensation no urination 排尿时的灼烧感dysurea 排尿困难，尿痛enuresis, bed wetting 遗尿frequency of urination 尿频micturation 排尿uresis, urination, voiding 排尿nocturia 夜尿oliguria 少尿polyuria 多尿tenesmus 里急后重vesical tenesmus 排尿时里急后重uremia coma 尿毒症昏迷urgency of urination 尿急urinary incontinence 尿失禁aciduria 酸尿chyluria 乳糜尿cylindruia 管型尿glycosuria 糖尿hematuria 血尿ketonuria 酮尿pneumatinuria 气尿proteinuria 蛋白尿pyuria 脓尿amenorrhea 经闭，无月经dysmenorrhea 痛经menorrhagia 月经过多lochia 恶露menorrhea 行经，月经过多menstruation 月经uterine contraction 子宫收缩blotch 斑点bruise 挫伤，青肿acne 痤疮，粉刺desquamation 脱皮，脱屑ecchymosis 瘀斑loss of skin turgor 失去皮肤充盈nevus 痣papule 丘疹petechia 瘀点，瘀斑pigmentation 色素沉着pustule 脓疱purpura 紫癫red nodule 红结节roseola 玫瑰疹scar 伤疤senile plaque 老人斑spider anaioma 蛛形痣subcutaneous nodule 皮下结节urticaria 荨麻疹vesicle 小水疱vitiligo 白斑blindness 失明blurred vision, visual disturbance 视力模糊impaired vision 视力下降lacrimation 流泪papilledema 视神经乳头水肿photophobia 畏光，羞明retinal detachment 视网膜脱离deafness 聋hearing loss 听力丧失tinnitus 耳鸣epistaxis, nasal bleeding 鼻出血impaired smelling 嗅觉障碍nasal discharge 鼻涕nasal obstruction 鼻塞sneeze 喷嚏snore 打鼾aphonia, loss of voice 失音症hoarseness 嘶哑gum bleeding 齿龈出血herpes labialis 唇疱疹，感冒疮Koplik's spots 科普利克斑lead line of the gum 龈铅线salivation, drooling 流口水straw-berry tongue 草莓舌tremulous tongue 舌震颤atrophy 萎缩contracture 挛缩deformity 畸形，变形dislocation 脱位fracture 骨折closed （simple）fracture 无创骨折，单纯性骨折comminuted fracture 粉碎性骨折compound fracture 哆开（开放性）骨折knock-knee 膝外翻opisthotonos 角弓反张prosthesis 假体spasm 痉挛tetany （肌）强直，手足抽搦wrist drop 腕下垂aphasia 失语ataxia 共济失调coma 昏迷consciousness 知觉，意识convulsion 抽搐，惊厥delirium 谵妄delusion 妄想faint 昏厥hallucination 幻觉hemiplegia 偏瘫increased intracranial pressure 颅内压增高insanity 精神错乱loss of orientation 定向丧失mania 躁狂memory defects, amnesia 记忆缺损，遗忘症paraplegia 截瘫，下身麻痹projectile vomiting 喷射性呕吐somnolence, （lethargy）昏睡，嗜睡stupor 木僵，昏呆tetraplegia 四肢瘫痪unconsciousness 失去知觉yawning 打哈欠crisis 危象cerebral （febrile, hematic, hemolytic,hypertensiv e, thyrotoxic, ……）crisis脑（热、血性、溶血、高血压、甲状腺中毒…）危象failure 衰竭，故障centra（circulatory, cardiac, myocardiac, peripheral, congestive, renal, respiratory）failure中枢（循环、心力、心肌、周围循环、充血性、肾、呼吸…）衰竭diagnosis诊断auscultation 听诊inspection 视诊palpation触诊percussion 叩诊laboratory examination 实验室检查physical examination 体格检查rectal （vaginal）touch 直肠（阴道）指诊impression 印象tentative diagnosis 暂定诊断differential diagnosis 鉴别诊断final diagnosis 最后诊断prognosis 预后prescription 处方incubation （latent）period 潜伏期prodromal stage 前驱期incipient stage 初期quiescent stage 静止期alleviation 减轻，缓和remission 缓解attack 发作convalescence （recovery）stage 恢复期rehabilitation 康复relapse 复发sudden death 猝死moribund 濒死的course of the disease 病程course of the treatment 疗程indication 适应症，指征complication 并发症contraindication 禁忌症side-effect 副作用sequel （sequela）, after effect 后遗症therapies 治疗方法acupuncture therapy 针刺疗法block therapy 封闭疗法chemical therpy （chemo-therapy）化学疗法combined therapy 综合疗法conservative therapy 保守疗法constitutional therapy 全身疗法dietetic therapy 饮食疗法operative treatment 手术疗法palliative treatment, alleviative treatment 姑息疗法physical therapy 物理疗法psychotherapy 精神疗法radical treatment 根治radio-therapy 放射性疗法supporting treatment 支持疗法symptomatic treatment对症疗法cardiac massage 心脏按摩cardiac pacing 心脏起博electrotherapy 电疗法electroshock treatment 电休克疗法hemodialysis 血液透析hyperbaric therapy 高压氧疗法insulin-shock treatment 胰岛素休克疗法light therapy 光疗法Urine Analyzer 尿液分析仪blood sugar（glucose ）analyzer血糖分析仪test strip 测试条reagent 试剂Semi-automatic Biochemical Analyzer半自动生化分析仪Automatic Blood Cell Analyzer全自动血细胞分析仪Urine sediments analyzer尿沉渣Bio-safety Cabinet 生物安全柜Incubator培养箱High Frequency Electrotome 高频电刀shadowless lamp无影灯High speed refrigerated centrifuge高速冷冻离心机hot air sterilizer热空气消毒箱microbiological incubator微生物培养箱Halogen light 卤素灯needle destroyer针头销毁器automatic packer自动纸塑包装机scalp vein set头皮针uniprocessor version单机版network version网络版macromolecule-solvent 高分子溶解的macromolecule cold accumulation 高分子蓄冷cold treatment冷疗法ice pack冰袋eyeshade 眼罩Medical injection pump医用灌注泵lithotrite 碎石机extracorporeal shock wave lithotrite体外冲击碎石机Ballistic intracroporeal lithotrite 气压冲击体内碎石机Laparoscope 腹腔镜Urology 泌尿外科kidney stones 肾结石Multi-parameter monitor, 多参数监护仪maternal monitor/fetal monitor母亲/胎儿监护仪ICU monitor 重症监护仪anesthetic equipment 麻醉机respirator呼吸机electronic colposcope 电子阴道镜smog absorber烟雾吸收器digital film room 数字胶片室Permanent Magnet Open Magnetic Resonance system 永磁开放式磁共振系统Ultrasonic Color Doppler Diagnostic system彩色超声多普勒诊断系统Mobile CT system 移动CT系统X-ray Mammary Machine 乳腺X线机Mammography乳腺high precision Stereotaxic 高精度脑立体定向仪portable Type-B ultrasonic 便携式B超Sterilization and Disinfection Equipment消毒灭菌设备Radiotherapeutic equipment.放射疗法设备pharmaceutical equipments.制药设备horizontal pressurized steam sterilizer普通卧式压力蒸汽灭菌器medical electronic linear accelerator医用电子直线加速器high frequency X-rays diagnostic machine高频X射线诊断机simulated positioner模拟定位机high frequency mobile X-rays machine高频移动X射线机医疗卫生人员职衔职称主任医师（讲课）：Professor of Medicine主任医师（医疗）：Professor of Treatment儿科主任医师：Professor of Paediatrics主治医师：Doctor-in-charge外科主治医师：Surgeon-in-charge内科主治医师：Physician-in-charge眼科主治医师：Oculist-in-charge妇科主治医师：Gynaecologist-in-charge牙科主治医师：Dentist-in-charge医师：Doctor医士：Assistant Doctor主任药师：Professor of Pharmacy主管药师：Pharmacist-in-charge药师：Pharmacist药士：Assistant Pharmacist主任护师：Professor of Nursing主管护师：Nurse-in-charge护师：Nurse Practitioner护士：Nurse主任技师：Senior Technologist主管技师：Technologist-in-charge技师：Technologist技士：Technician常用抗菌药物青霉素类青霉素(G) Penicillin(G) Benzylpenicillin, 苄青霉素, 盘尼西林青霉素V Penicillin V Phenoxymethylpenicillin, Blinvan, Ospen, 苯氧甲基青霉素苄星青霉素Benzathine Penicillin 长效西林, 长效青霉素, 比西林, LPG, 苄星青氨苄西林Ampicillin 安比西林, 氨苄青霉素, 安必仙, 安必林, 安比林阿莫西林Amoxicillin 特力士, 弗来莫星, 羟氨苄青霉素, 益萨林, 阿莫仙, 安福喜, 本原莫星巴氨西林Bacampicillin 美洛平, 氨卡西林, 氨苄青霉素甲戊酯阿洛西林Azlocillin 阿乐欣, 咪氨苄西林, 氧咪苄青霉素, Azlin美洛西林Mezlocillin 天林, Baypen, Mezlin, Baycipen替卡西林Ticarcillin 羧噻吩青霉素, 的卡西林, Nonapen, Ticarpen酞氨西林Talampicillin 氨苄青霉素酞酯, 酞氨苄青霉素, 酞氨苄西林, TAPC, Talpen夫苄西林Furbenicillin 呋脲苄青霉素, 呋苄青霉素, 呋氨西林, 呋喃酰脲苄青霉素氟氯西林Flucloxacillin 氟氯苯唑青霉素, 氟沙星, 福氯平, Floxapen羧苄西林Carbenicillin 羧苄青霉素, 卡比西林, 羧苄青阿扑西林Aspoxicillim 天冬羟氨青霉素, Doyle, ASPC匹氨西林Pivampicillin 氨苄西林酯, 匹凡西林, 匹呋西林, 吡呋氨卡西林双氯西林Dicloxacillin 双氯青, Dynapen, Consaphyl, Stampen, Diflor甲氧西林Meticillin 新青霉素Ⅰ, 美替西林, Azapen, Penysol苯唑西林钠Oxacillin Sodium 新青霉素Ⅱ, 苯唑青霉素钠, 苯甲异噁唑青霉素奈夫西林Nafcillin 新青霉素Ⅲ, 乙氧萘青霉素匹美西林Pivmecillinam 氮卓咪青霉素双酯, Celfuron, Melysin仑氨苄西林Lenampicillin Varacillin, Takacillin美西林Mecillinam Selexidleo, Selexid, Coactin, Amdinocillin, 氮卓脒青霉素哌拉西林钠Piperacillin Sodium 氧哌嗪青霉素, 哔哌西林, 哌氨苄青霉素Avocin, Orocin, Pipril氯唑西林钠Cloxacillin Sodium 邻氯青霉素钠, 氯唑青, Orbenin阿帕西林钠Apalcillin Sodium 萘啶青霉素钠, APPC, Lumota, Elumota, Palcin磺苄西林钠Sulbenicillin Sodium 磺苄青霉素钠, 卡他西林, 格达西林Sulfocillin, Lilacillin, Kedacillin青霉素V钾Phenoxymethylpenicillin Potassiume 6–苯氧乙酰胺基青霉烷酸钾, Cillaphen Distaquaine VK, Compocillin VK, Dowpen VK Cilicaine VK, Apopen, Biopen海他西林钾Hetacillin Potassium 缩酮氨苄青霉素钾, Etacillin, Veisapen卡茚西林钠Carindacillin Sodium Carbenicillin Indanyl Sodium, Geopen, Geocillin 治平霉素替莫西林二钠Temocillin Disodium Temopen头孢菌素类第一代头孢噻吩钠Cefalotin Sodium 先锋Ⅰ号, 头孢金素, 噻孢霉素, CET头孢噻啶Cefaloridine 先锋Ⅱ号, 头孢利素, CER, Kafspor头孢来星Cefaloglycine 先锋Ⅲ号, 头孢甘酸, Kafocin, Kefglycin头孢氨苄Cefalexin 先锋Ⅳ号, 苯甘孢霉素, 头孢力新, CEX头孢唑啉钠Cefazolin Sodium 先锋Ⅴ号, 塞福宁, 西华乐林, 先锋啉, 凯复唑Cefalin, CEX, Cefamedin, Kefzol, Cramaxin头孢拉定Cefradine 先锋Ⅵ号, 头孢雷定, 头孢瑞丁, 头孢环已烯，泛捷复, Velosef, CED, 塞福定头孢乙腈Cefacetrile 先锋Ⅶ号, 头孢腈甲, 头孢赛曲头孢匹林Cefapirin 先锋Ⅷ号, 头孢吡硫, Ceta-Dri头孢硫脒Cefathiamidine 先锋18, 吡脒头孢头孢克洛Cefaclor 赐福乐素, 新达乐, 头孢氯氨苄, Ceclor, 希刻劳，头孢克罗, 可福乐, 氯头孢菌素, CCL头孢羟氨苄Cefadroxil Cefadril, Kefroxil, 羟氨苄头孢菌素, 欧意, CDX，Duracef, Bidocef, Cefamx头孢沙定Cefroxadine 头孢环烯氨, ORASPON, CGP-9000, CXD头孢罗齐Cefprozil 头孢丙烯, Cefzil头孢替唑Ceftezole 特子社复, Tezacef, Alomen第二代头孢呋辛钠Cefuroxime Sodium 头孢呋肟, 赐福乐信, 舒贝洛, 西力欣, 特力欣, 明可欣, CXM, Zinacef, Monacef, Ketocef, Furex Kesiut, Supero头孢替安Cefotiam 噻乙胺唑头孢菌素, 头孢噻乙胺唑, 泛司博林, 泛司颇灵, Pansparin, Halospor, CTM头孢呋辛酯Cefuroxime Axetil 头孢呋肟酯, 新菌灵, 西力达, 头孢呋新乙酰乙酯Zinnat头孢西丁Cefoxitin 头孢氧唑, 甲氧头霉噻吩, 噻吩甲氧头孢菌素, 美福仙, 甲氧头霉噻吩, CXT, CFX头孢尼西二钠Cefonicid Disodium 铭乐希, Monocid, Cefonicid, Cefodie, Cefol头孢孟多Cefamandole 头孢羟唑, 羟苄四唑头孢菌素, Mandolkef, CMT, Cefadole, Mandol头孢美唑钠Cefmetazole Sodium 先锋美他醇, 氰唑甲氧头孢菌素, 头孢氰四唑,头孢美他唑, CEFMETAZON, CMZ, Cemetol头孢布宗Cefbuperazone 头孢拉宗, Keiperazon, Tomiporan, Cefobutazine, CBPZ 头孢雷特Ceforanide 头孢氨甲苯唑, 头孢苄胺四唑, 氨苄唑头孢菌素Precef第三代头孢地尼Cefdinir Cefzon头孢布坦Ceftibuten 头孢布烯, Cedax头孢卡品Cefcapene Pivoxil 头孢卡喷新戊酰氧甲酯, Flomox头孢噻肟钠Cefotaxime Sodium 头孢氨噻肟, 泰可欣, 塞福隆, 菌必灭, 治菌必妥, 凯福隆, 凯复龙, 头孢噻肟, 喜福得, Claforan, CTX头孢曲松钠Ceftriaxone Sodium 头孢三嗪, 头孢泰克松, 罗氏芬, 罗噻嗪, 菌必治, 菌得治, 头孢三嗪噻肟, 泛生舒复, 西华瑞隆, Rocephin, Ro-139904, CTRX 头孢哌酮钠Cefoperazone Sodium 头孢氧哌唑, 先锋必, 头孢必, 达诺欣, 塞福必，Cefobid, T-1551, CPZ头孢他啶Ceftazidime 头孢塔齐定, 头孢羧甲噻肟, 复达欣, 凯复定, Glazidine, Fortaz, Eposerin, Modocin, Fotrum, Tazidime, CTZ, Spectrum, Eposerin, Modocin头孢唑肟Ceftizoxime 头孢去甲噻肟, 益保世灵, 安保速灵, Epocelin CZX, CEFTIZOX头孢克肟Cefixime 头孢烯噻羟肟, 世伏素, 世福素, FK027, Suprax, CFIX , CEFSPAN头孢甲肟Cefmenoxime 头孢氨噻肟唑, 倍司特克, BESTCALL, CMX头孢地嗪Cefodizime 头孢双唑, 莫敌, 莫敌威, Modivid, Timcef头孢匹胺Cefpiramide 先福吡兰, 甲吡唑头孢菌素, 头孢吡胺, CPM，Cefpiran, Sepatren头孢特仑酯Cefteram Pivoxil 头孢特仑新戊酰氧甲酯, 托米仑, 头孢他美酯，富山龙, Tomiron头孢磺吡苄钠Cefsulodin Sodium 头孢磺吡酮, 头孢磺啶钠, 磺吡苄头孢菌素钠，达克舒林, Cefsulodine, Takesulin, CFS, SCE129拉他头孢Latamoxef 羟羧氧酰胺菌素, 拉氧头孢, 头孢拉坦, 噻吗灵Moxalactam, Shiomarin, Moxam, LMOX头孢米诺Cefminox 氨羧甲氧头孢菌素, 美土灵, Meicelin头孢咪唑Cefpimizole Benilan, SPIE, Ajicef头孢替坦二钠Cefotetan Disodium 双硫唑甲氧头孢霉素, Yamatetan, CTT, Cefotan第四代头孢唑喃钠Cefuzonam Sodium Cosmosin, CZON氟氧头孢钠Flomoxef Sodium 氟莫克西, 6315-S头孢匹罗Cefpirome 头孢吡隆, 氨噻肟吡戊头孢其它Β-内酰胺类亚胺培南Imipenem 伊米配能, 亚胺硫霉素, NFT氯曲南Aztreonam 菌克单, 君刻单, 噻肟单酰胺菌素, AZACTAM，Primbactam, Primbactin, SQ-26776氟罗培南Faropenem 福劳派南, Farom苄西林/氯唑西林Ampicillin/Cloxacillin 复方安比西林, 爱罗苏, 氨氯西林, 白罗仙, 淋必清, Pinocine亚胺培南/西司他丁Imipenem/Cilastatin 亚胺硫霉素/西拉司丁, 泰能, TIENAM, PRIMAXIN阿莫西林/氟氯西林Amoxicillin/Flucloxacillin 氟羟西林, 新灭菌, Biflocin, Infectrin三羟阿莫西林/单羟双氯西林Amoxycillin Trihydrate/Dicloxacillin康彼身, 克菌, CompliscanΒ-内酰胺类抗生类+Β-内酰胺酶抑制剂氨苄西林/舒巴坦Ampicillin/Sulbactam 强力安必仙, 舒他西林, 优力新, 新凯兰欣, 舒氨欣, Unasyn, Sultamicillin头孢哌酮/舒巴坦Cefoperazone/Sulbactam 舒普深, 舒哌酮, Sulperazone头孢噻肟/舒巴坦Cefotaxime/Sulbactam 新治菌哌拉西林/他佐巴坦Piperacillin/Tazobactam Tazocin, YP-14阿莫西林/克拉维酸Amoxillin/Clavulanic Acid 安灭菌, 安美汀, 奥格门汀, 安美汀, 阿莫克拉Augmentin, BRL25000替卡西林/克拉维酸Ticarcillin/Clavulanic Acid 泰门汀, 特泯菌, 特美汀, Timentin舒巴坦Sulbactam 舒巴克坦, 陪他美, 青霉烷砜氨基糖甙类链霉素Streptomycin RIMACTANE, RIFAMPINN, ovostrep庆大霉素Gentamycin 庆大霉素C, 瑞贝克, 正泰霉素庆大霉素链Gentamicin Chains 塞透派勒链, Septopal妥布霉素Tobramycin 立可信软膏，点必舒眼药水（妥布＋地塞米松）泰星，妥布拉霉素，托普霉素，NEBCIN，Factorb, Brulamycin, Tobra, Nebramycin, Gernebcin, Obracine小诺霉素Micronomicin 小诺米星, 沙加霉素, 相模霉素, Sagamicin, Kw-1062, MCR核糖霉素Ribostamycin 威他霉素, 维生霉素, Vistamycin, Ibistacin大观霉素Spectinomycin 奇霉素, 壮观霉素, 淋必治, 奈毒素, Spectram, 克淋, Trobicin, Kirin阿米卡星Amikacin 丁胺卡那霉素, Amikin, Likacin西索米星Sisomicin 西梭霉素, 西索霉素, 紫苏霉素, Sisomin, Sipeptin奈替米星Netilmicin 乙基西梭霉素, 奈特, 奈替霉素, 乙基西素米星, 立克菌星, 乙基紫苏毒素, Ethylsisomicin, Vectacin, Zetamicn, Certomycin, NETROMYCIN异帕米星Isepamicin 依克沙霉素, HAPA-B, Exacin阿司米星Astromicin 阿司霉素, 福提霉素, 武夷霉素, 强壮霉素FORTIMICIN, Kw-1070, ASTM, Fortimicin地贝卡星Dibekacin 双去氧卡那霉素B, Dideoxykanamycin B, DKB, 达苄霉素, Icacine依替米星Etimicin 悉能磷霉素类磷霉素Fosfomycin 福赐美仙, Phosphonomycin, Fosfocina, FOＭ磷霉素氨基丁三醇Fosfomycin Tromethamine Monurol喹诺酮类第二代吡哌酸Pipemidic Acid PPA第三代诺氟沙星Nofloxacin 氟哌酸, 淋克星, Fulgram, Noroxin, AM-715 MK-0366, Brazan, Baccidal环丙沙星Ciprofloxacin 悉复欣, 悉普欣, 悉普宁, 丽珠环丙, 特美力，环丙氟哌酸, 健宝灵, CIPRO, Bay-0-9867, Ciprobay, Ciproxin培氟沙星Pefloxacin 培福新, 甲氟哌酸, 倍泰, Peflacine洛美沙星Lomefloxacin 洛威, 罗氟酸, 欣美罗, 多龙, Bareon芦氟沙星Rufloxacin 如氟沙星左旋氧氟沙星Levofloxacin 可乐必妥, 左氟沙星, Cravit依诺沙星Enoxacin 氟啶酸, 福禄马, 复克, FLUMARK, GYRAMID，Flumark氟罗沙星Fleroxacin 复诺定, 多氟哌酸, 喹诺敌, 麦加乐定, 沃尔得FLX, Megelone, Quinodis, Ro-236240, AM-833氧氟沙星Ofloxacin 氟嗪酸, 秦利必妥, 泰利特, 奥复星, 康泰必妥, 竹安新, TARIVID, 赞诺欣, Zanoxin, Oflocin, 泰利得, 正康培氟沙星Pefloxacin 甲氟哌酸, 培氟哌酸, 培福新, 倍宁, Pefalcine。
临床试验中英对照词汇表englishvocabularyofclinicaltrials
Abbr/缩写Englishi/英文Chinese/中文AASV accompanied site visit陪同访视accuracy准确度AC active control阳性对照，活性对照ADR adverse drug reaction药物不良反应AE adverse event不良事件adverse medical events不良医学事件adverse reaction药物不良反应ALT alanine aminotransferase丙氨酸氨基转换酶Alb albumin白蛋白ALP alkaline phosphatase碱性磷酸酶alpha spending function消耗函数analysis sets统计分析的数据集annotated crf注释CRF表approval批准FM approved standard form标准批准表格ALD approximate lethal dose近似致死剂量AUC area under curve药时曲线下面积AST aspartate aminotransferase天门冬酸氨基转换酶assistant investigator助理研究者ATR attenuated total reflection衰减全反射法AUCss 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Cav average concentration平均浓度Bbias偏性，偏倚bind 绑定，将履行自己法律义务和／或在法律上负责。
BE bioequivalence生物等效应BS biostatistics生物统计BSF biostatistics study file生物统计学文件夹blank control空白对照blind codes编制盲底blind review盲态检查blinding盲法，设盲blinding method盲法block分段/层block size每段的长度BUN blood urea nitrogen血尿素氮BMI body mass index体重/身高的平方BD business development业务拓展Ccarryover effect延滞效应case history病历CRF case report form/ case record form病例报告表，病例记录表categorical variable分类变量CDC center for disease control疾病控制中心ENGLISH VOCABULARY OF CLINICAL TRIALSCDE center for drug evaluation 国家食品药品监督管理局药品审评中心CCF central clinical file申办方临床研究文件夹CEC central ethics committee中心伦理委员会CIF central investigator's file中心研究者文件夹CDA certified data analyst数据分析师COF change order form工作变更申请表CMC chemistry manufacturing and controls临床前药学研究CMO chief media officer首席医学官CFDA china food and drug administration国家食品药品监督管理总局CD circular dichroism圆二色谱CL clearance清除率clinical auditor临床稽查员CDMS clinical data management system临床数据管理系统clinical director临床总监clinical equivalence临床等效应CMA clinical monitoring associate临床研究监查助理CM clinical monitoring/operations临床监查/运营CPA clinical project assistant临床项目助理CRA clinical research associate临床研究监察员，临床研究助理CRC clinical research coordinator临床协调员clinical study临床研究CSDs clinical study documents临床研究文件CSR clinical study report临床研究报告CTMS clinical trail management system临床试验管理系统clinical trial临床试验CTA clinical trial agreement临床试验协议CTA clinical trial application临床试验申请CTA clinical trial assistant临床研究助理CTX clinical trial exemption临床试验免责CTP clinical trial protocol临床试验方案CTS clinical trial supplies临床试验用品clinical trial/ study report临床试验报告Cmax cmax，maximum concentration峰浓度CI co-inveatigator合作研究者CTD common technical document国际药品注册申请技术文件格式comparison对照CR complete response完全缓解compliance依从性composite variable复合变量CATD computer-assisted trial design计算机辅助试验设计confidence interval可信区间confidence level置信水平CDA confidentiality disclosure agreement保密协议consistency test一致性检验CRO contract research organization合同研究组织contract/ agreement协议／合同control group对照组CD controlled documents控制文件coordinating committee协调委员会COI coordinating investigator协调研究者CAPA corrective action & preventive action纠正/预防措施CIOMS council for international organizations ofmedical sciences国际医学科学组织理事会cov close out visits关闭访视crea肌酐cross-over study交叉设计Css css, steady-state concentration稳浓度cure痊愈CV curriculum vitea履历DDCRF data clarification and resolution form数据澄清和解决表DCF data clarification form数据澄清表DCR data clarification report数据澄清报告DM data management数据管理DMP data management plan数据管理计划书DMSF data management study file数据管理研究文件夹DQF data query form数据疑问表database建立数据库database go live数据库批准启动DF degree of fluctuation波动度/系统descriptive statistical analysis描述性统计分析dichotomies二分类DSC differential scanning calorimetry示差扫描量热法DFS disease free survival无病生存期diviation偏差documentation记录／文件DLT dose limting toxicity剂量限制毒性dose-reaction relation剂量－反应关系double blinding双盲double dummy双模拟double dummy technique双盲双模拟技术double-blinding双盲dro out脱落drug-oriented药物源性Eeffectiveness疗效eCRF electronic case report form电子病历报告表EDC electronic data capture电子数据采集系统EDP electronic data processing电子数据处理系统emergency envelope应急信件EOS end of study研究结束end point终点endpoint criteria/ measurement终点指标equivalence等效性essential documentation必须文件EC ethics committee伦理委员会ESH-ESC european soceity of hypertension-europeansociety of cardilogy欧洲高血压-心脏协会EU european union欧盟EBM evidence-based medicine循证医学excellent显效exclusion criteria排除标准Ffactorial design析因设计failure无效，失败final point终点fixed-dose procedure固定剂量法FDA food and drug administration 食品药品管理局/美国食品药品管理局forced titration强制滴定FAS full analysis set全分析集GGC－FTIR gas chromatography-fourier transforminfrared spectroscopy气相色谱－傅利叶红外联用GC－MS gas chromatography-mass spectrometer气相色谱－质谱联用generic drug通用名药global assessment variable全局评价变量GLU glucose葡萄糖GAP good agricultural practice中药材种植管理规范GCP good clinical practice药物临床试验质量管理规范GLP good laboratory practice药品实验室管理规范GMP good manufacturing practice药品生产质量管理规范GLP good non-clinical laboratory practice药物非临床研究质量管理规范GSP good supply practice药品经营质量管理规范GUP good use practice药品使用质量管理规范group sequential design成组序贯设计HHCO head of clinical operations临床运营总监HEV health economic evaluation健康经济学评价HCT historial control trial历史对照研究HIM hospital intensive monitoring医院集中监测hypothesis test假设检验IIRAEs immediately reportable adverse events立即上报的不良反应improvement好转inclusion criteria入选标准IEC independent ethics committee独立伦理委员会information gathering信息收集IT information technology信息技术IC informed consent知情同意ICF informed consent form知情同意书IR infrared radiation红外吸收光谱initial meeting启动会议inspection视察／检查institution inspection机构检查IRB institutional review board机构伦理委员会ICH intennational conference on hamonization oftechnical requirements for registration ofpharmaceuticals for human use人用药品注册技术要求国际技术协调会/国际协调会议ICH-GCP intennational conference on hamonizationtripartite guideline on good clinicalpractice国际协调会议药品临床试验质量管理规范指南intention to treat意向性治疗ITT intention-to –treat意向性分析IVRS interactive voice response system互动式语音应答系统interim analysis期中分析IDB investigational drug brochure试验药物手册IND investigational new drug新药临床研究IP investigational product研究用产品investigator研究者ISF investigator site file研究者文件夹ISA investigator study agreement研究者合同IB investigator's brochure研究者手册IXRS ixsystems交互式互动服务提供商JKKPS karnofsky performance status行为状态评分LLOCF last observation carry forward最近一次观察的结转LD50lethal dose, 50%半数致死剂量LOI letter of intent意向书LOQ limit of quantitation定量限LM line manager直线经理LC－MS liquid chromatography -mass spectrometry液相色谱－质谱联用logic check逻辑检查lost of follow up失访Mmarketing approval/ authorization上市许可证masking设盲MRT mass rapid transit平均滞留时间MS mass spectrometry质谱MS－MS mass spectrometry-mass spectrometry质谱－质谱联用MSA master services agreement主服务协议matched pair匹配配对MTD maximal tolerable dose最大耐受剂量MedDRA meddra ICH国际医学用语词典medical director医学总监MW medical writing医学写作MOH ministry of health卫生部missing value缺失值mixed effect model混合效应模式monitor监查员monitoring监查monitoring report监查报告multi-center trial多中心试验NNCE new chemical entity新化学实体NDA new drug application新药上市申请NOAEL no observed adverse effect level未见不良反应剂量水平non-clinical study非临床研究non-inferiority非劣效性non-parametric statistics非参数统计方法NRCCT non-randomized concurrent controlled trial非随机同期对照试验 NA not available不可用NCS not clinically significant无临床意义ND not done未做NMR nuclear magnetic resonance核磁共振Oobedience依从性ODR odr旋光光谱offsite archive异地存档on-site monitoring现场监查on-target monitoring目标化监查open-blinding非盲open-label非盲OP operation procedure操作规程OTL opperational team lead运营团队负责人optional titration随意滴定original medical record原始医疗记录OD other documents其他文件OOS out of scope超出工作范围outcome结果outcome assessment结果指标评价outcome measurement结果指标outlier离群值OS overall survival总生存时间Pparallel group design平行组设计parameter estimation参数估计parametric statistics参数统计方法PR partial response部分缓解patient file病人档案patient history病历PR patient recruitment患者招募patient-oriented人源性PP per protocol符合方案集PMI periodic maintenance inspection定期维护检查PIN personal identification number个人确认密码PK phamacokinetics药物代谢动力学PD pharmacodynamics药效学；药代动力学PKAS pharmacokinetics analysis set药代动力学分析集placebo安慰剂placebo control安慰剂对照polytomies多分类PMS post-marketing study上市后临床试验PMS post-marketing surveillance上市后药物检测power检验效能PSV pre –study visit启动前访视precision精密度preclinical study临床前研究primary endpoint主要终点primary variable主要变量PI principal investigator主要研究者PL product license产品许可证PD progressive disease病情进展PMF project management file项目管理文件夹PM project maneger项目经理protocol试验方案protocol amendment方案补正PD protocol deviation方案偏离PFDA pure food and drug administration (美国)食品及药物管理局(正式名称为Food and Drug Administration,略作FDA)QQA quality assurance品质保证QAU quality assurance unit质量保证部门QC quality control质量控制query form应用疑问表query list应用疑问表Rrandomization随机化RCT randomized controlled trial随机对照试验range check范围检查rating scale量表reconciliation和解RM records management记录管理RA regulatory affairs注册事务RA regulatory authorities监督管理部门RSD relative standard deviation日内和日间相对标准差RM remote monitoring远程监查replication可重复RECIST response evaluation criteria in solid实体瘤疗效反应的评价标准RMV routine monitoring visits例行监查run in准备期SSAS safety analysis set安全性评价的数据集safety evaluation安全性评价sample size样本量scale of ordered categorical ratings有序分类指标SOW scope of work工作范围secondary variable次要变量sequence试验次序SAR serious adverse reaction严重不良反应seriousness严重性severity严重程度SAE severity adverse event严重不良事件significant level检验水准simple randomization简单随机single blinding单盲site audit试验机构稽查SCV site close-out visit中心关闭访视SIF site information form中心信息表SIV site intiation visits启动访视SMV site monitoring visit中心监查方式SSV site selection visit中心筛选访视SVR site visit report中心访视报告SD source data原始数据SD source document原始文件SDV soutce data verification原始数据核查specificity特异性sponsor申办者sponsor-investigator申办研究者SD stable disease病情稳定standard curve标准曲线SD standard deviation标准差SOP standard operating procedure标准操作规程SFDA state food and drug administration 中国国家食品药品监督管理局的旧称statistic统计量statistical analysis plan统计参数计划书statistical model统计模型statistical tables统计分析表stratified分层study aud研究稽查SC study coordinator研究协调员subgroup亚组Sub-I subinvestigator次要研究者SI sub-investigator助理研究者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SIC subject identification code受试者识别代码subject recruitment受试者招募subject screening log受试者筛选表superiority检验survival analysis生存分析SUSAR suspected unexpected sar疑似非预期严重不良反应sxrd单晶X－射线衍射system audit系统稽查Ttarget variable目标变量TP template模板MRHD the maximum recommended human dose最高推荐人用剂量TG thermogravimetric analysis热重分析T1/2time 1/2消除半衰期TTP time-to-progression 疾病进展时间tlc、hplc制备色谱tmax达峰时间TP total protein总蛋白T－BIL total-bilirubin总胆红素T－CHO total-cholesterol总胆固醇TR training培训transformation变量变换treatment group试验组trial error试验误差TMF trial master file试验主文件夹trial objective试验目的trial site临床试验中心triple blinding三盲two one-side test双单侧检验UUV－VIS ultraviolet–visible spectroscopy紫外可见吸收光谱UADE unanticipated adverse drug effect非预期不良反应unblinding揭盲/破盲UADR unexpected adverse drug reaction非预期药物不良反应 UAE unexpected adverse event非预期不良事件Vvariability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Wwash-out清洗期washout period洗脱期well-being福利，健康WI work instruction工作指南XYZ。
临床试验英语词汇
临床试验英语词汇-CAL-FENGHAI.-(YICAI)-Company One1专业术语、缩略语中英对照表缩略语英文全称中文全称ABE Average Bioequivalence 平均生物等效性AC Active control 阳性对照ADE Adverse Drug Event 药物不良事件ADR Adverse Drug Reaction 药物不良反应AE Adverse Event 不良事件AI Assistant Investigator 助理研究者ALB Albumin 白蛋白ALD Approximate Lethal Dose 近似致死剂量ALP Alkaline phosphatase 碱性磷酸酶ALT Alanine aminotransferase 丙氨酸转氨酶ANDA Abbreviated New Drug Application 简化新药申请ANOVA Analysis of variance 方差分析AST Aspartate aminotransferase 天冬氨酸转氨酶ATR Attenuated total reflection 衰减全反射法BA Bioavailability 生物利用度BE Bioequivalence 生物等效性BMI Body Mass Index 体质指数BUN Blood urea nitrogen 血尿素氮CATD Computer-assisted trial design 计算机辅助试验设计CDER Center of Drug Evaluation and Research 药品评价和研究中心CFR Code of Federal Regulation 美国联邦法规CI Co-Investigator 合作研究者CI Confidence Interval 可信区间COI Coordinating Investigator 协调研究者CRC Clinical Research Coordinator 临床研究协调者CRF Case Report/Record Form 病历报告表/病例记录表CRO Contract Research Organization 合同研究组织CSA Clinical Study Application 临床研究申请CTA Clinical Trial Application 临床试验申请CTP Clinical Trial Protocol 临床试验方案CTR Clinical Trial Report 临床试验报告CTX Clinical Trial Exemption 临床试验免责CHMP Committee for Medicinal 人用药委会Products for Human UseDSC Differential scanning 差示扫描热量计DSMB Data Safety and monitoring Board 数据安全及监控委员会EDC Electronic Data Capture 电子数据采集系统EDP Electronic Data Processing 电子数据处理系统EWP Europe Working Party 欧洲工作组FDA Food and Drug Administration 美国食品与药品管理局FR Final Report 总结报告GCP Good Clinical Practice 药物临床试验质量管理规范GCP Good Laboratory Practice 药物非临床试验质量管理规范GLU Glucose 葡萄糖GMP Good Manufacturing Practice 药品生产质量管理规范HEV Health economic evaluation 健康经济学评价IB Investigator’s Brochure研究者手册IBE IndividualBioequivalence 个体生物等效性IC Informed Consent 知情同意ICF Informed Consent Form 知情同意书ICH International Conference on Harmonization 国际协调会议IDM Independent Data Monitoring 独立数据监察IDMC Independent Data Monitoring Committee 独立数据监察委员会IEC Independent Ethics Committee 独立伦理委员会IND Investigational New Drug 新药临床研究IRB Institutional Review Board 机构审查委员会ITT Intention-to –treat 意向性分析IVD In Vitro Diagnostic 体外诊断IVRS Interactive Voice Response System 互动语音应答系统LD50 Medial lethal dose 半数致死剂量LLOQ Lower Limit of quantitation 定量下限LOCF Last observation carry forward 最接近一次观察的结转LOQ Limit of Quantitation 检测限MA Marketing Approval/Authorization 上市许可证MCA Medicines Control Agency 英国药品监督局MHW Ministry of Health and Welfare 日本卫生福利部MRT Mean residence time 平均滞留时间MTD Maximum Tolerated Dose 最大耐受剂量ND Not detectable 无法定量NDA New Drug Application 新药申请NEC New Drug Entity 新化学实体NIH National Institutes of Health 国家卫生研究所（美国）NMR Nuclear Magnetic Resonance 核磁共振PD Pharmacodynamics 药效动力学PI Principal Investigator 主要研究者PK Pharmacokinetics 药物动力学PL Product License 产品许可证PMA Pre-market Approval (Application) 上市前许可（申请）PP Per protocol 符合方案集PSI Statisticians in the Pharmaceutical Industry 制药业统计学家协会QA Quality Assurance 质量保证QAU Quality Assurance Unit 质量保证部门QC Quality Control 质量控制QWP Quality Working Party 质量工作组RA Regulatory Authorities 监督管理部门REV Revision 修订SA Site Assessment 现场评估SAE Serious Adverse Event 严重不良事件SAP Statistical Analysis Plan 统计分析计划SAR Serious Adverse Reaction 严重不良反应SD Source Data/Document 原始数据/文件SD Subject Diary 受试者日记SDV Source Data Verification 原始数据核准SEL Subject Enrollment Log 受试者入选表SFDA State Food and Drug Administration 国家食品药品监督管理局SI Sponsor-Investigator 申办研究者SI Sub-investigator 助理研究者SIC Subject Identification Code 受试者识别代码SOP Standard Operating Procedure 标准操作规程SPL Study Personnel List 研究人员名单SSL Subject Screening Log 受试者筛选表T&R Test and Reference Product 受试和参比试剂T－BIL Total Bilirubin 总胆红素T－CHO Total Cholesterol 总胆固醇TG Thromboglobulin 血小板球蛋白Tmax Time of maximum concentration 达峰时间TP Total proteinum 总蛋白UAE Unexpected Adverse Event 预料外不良事件WHO World Health Organization 世界卫生组织WHO- WHO International Conference WHO 国际药品管理当局会议ICDR A of Drug Regulatory AuthoritiesAberrant result 异常结果Absorption phase 吸收相Absorption 吸收Accuracy 准确度Accurate 精密度Administer 给药Amendment修正案Approval 批准Assess 估计Audit Report 稽查报告Audit 稽查Auditor 稽查员Analytical run/batch：分析批Benefit 获益Bias 偏性，偏倚Bioequivalence 生物等效Biosimilar /Follow-on biologics 生物仿制药Blank Control 空白对照Blind codes 编制盲底Blind review 盲态检查 /盲态审核Blinding method 盲法Blinding/masking 盲法/设盲Block size 每段的长度Block 层 /分段BCS 生物药剂学分类系统Carryover effect 延滞效应Case history 病历Clinical equivalence 临床等效性Clinical study 临床研究Clinical Trial Report 临床试验报告Comparison 对照Compensation 补偿，赔偿金Compliance 依从性Concomitant 伴随的Conduct 行为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Crossover design 交叉设计Cross-over Study 交叉研究Cure 痊愈Data management 数据管理Descriptive statistical analysis 描述性统计分析Dichotomies 二分类Dispense 分布Diviation 偏差Documentation 记录／文件Dosage forms 剂型Dose dumping 剂量倾卸（药物迅速释放入血而达到危险浓度）Dose-reaction relation 剂量－反应关系Double blinding 双盲Double dummy 双模Drop out 脱落Effectiveness 疗效Elimination phase 消除相Emergency envelope 应急信件Enantiomers 对映体End point 终点Endpoint criteria/ measurement 终点指标Enterohepatic recycling 肠肝循环Essential Documentation 必需文件Ethical 伦理的Ethics committee 伦理委员会Evaluate 评估Exclusion Criteria 排除标准Excretion 排泄Expedite 促进Extrapolated 外推的Essentially similar product：基本相似药物Factorial design 析因设计Failure 无效，失败Finacing 财务，资金Final point 终点First pass metabolism 首过代谢Fixed-dose procedure 固定剂量法Full analysis set 全分析集GC－FTIR 气相色谱－傅利叶红外联用GC－MS 气相色谱－质谱联用Generic drug 通用名药Gene mutation 基因突变Genotoxicity tests 生殖毒性试验Global assessment variable 全局评价变量Group sequential design 成组序贯设计Hypothesis test 假设检验Highly permeable：高渗透性Highly soluble：高溶解度Highly variable drug：高变异性药物Highly：Variable Drug 高变异性药物HVDP：高变异药物制剂Identification 鉴别，身份证Improvement 好转In vitro 体外In vivo 体内Inclusion Criteria 入选表准Information Gathering 信息收集Initial Meeting 启动会议Inspection 检察/视察Institution Inspection 机构检察Instruction 指令，说明Integrity 完整，正直Intercurrent 中间发生的，间发的Inter-individual variability 个体间变异性Interim analysis 期中分析Investigational Product 试验药物Investigator 研究者Involve 引起，包括IR 红外吸收光谱Innovator Product：原创药Ka 吸收速率常LC－MS 液相色谱－质谱联用logarithmic transformation 对数转换Logic check 逻辑检查Lost of follow up 失访Mask 面具，掩饰Matched pair 匹配配对Metabolism 代谢Missing value 缺失值Mixed effect model 混合效应模式Modified release products 改良释放剂型Monitor 监查员Monitoring Plan 监察计划Monitoring Report 监察报告MS－MS 质谱－质谱联用Multi-center Trial 多中心试验Negative 阴性，否定的Non-clinical Study 非临床研究Non-inferiority 非劣效性Non-Linear Pharmacokinetics 非线性药代动力学Non-parametric statistics 非参数统计方法NTID：窄治疗指数制剂Obedience 依从性Open-blinding 非盲Open-label 非盲Original Medical Record 原始医疗记录Outcome Assessment 结果评价Outcome measurement 结果指标Outlier 离群值OIP 经口服吸收药物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Permeability 渗透性Pharmacodynamic characteristics 药效学特征Pharmacokinetic characteristics 药代学特征Placebo Control 安慰剂对照Placebo 安慰剂Polytomies 多分类Post-dosing postures 给药后坐姿Potential 潜在的Power 检验效能Precision 精密度Preclinical Study 临床前研究Precursor 母体前体Premature 过早的，早发Primary endpoint 主要终点Primary variable 主要变量Prodrug 药物前体Protocol amendment 方案补正Protocol Amendments 修正案Protocol 试验方案Quality Control Sample：质控样品Rapidly dissolving：快速溶出Racemates 外消旋物Randomization 随机 /随机化Range check 范围检Rating scale 量表Recruit 招募，新会员Replication 可重复Retrieval 取回，补修Revise 修正Risk 风险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Sampling schedules 采血计划Scale of ordered categorical ratings 有序分类指标Secondary variable 次要变量Sequence 试验次序Seriousness 严重性Severity 严重程度Significant level 检验水准Simple randomization 简单随机Single Blinding 单盲Site audit 试验机构稽查Solubility 溶解度Specificity 特异性Specify 叙述，说明Sponsor-investigator 申办研究者Standard curve 标准曲线Statistical model 统计模型Statistical tables 统计分析表Steady state 稳态Storage 储存Stratified 分层Study Audit 研究稽查Study Site 研究中心Subgroup 亚组Sub-investigator 助理研究者Subject Enrollment Log 受试者入选表Subject Enrollment 受试者入选Subject Identification Code List 受试者识别代码表Subject Recruitment 受试者招募Subject Screening Log 受试者筛选表Subject 受试者Submit 交付，委托Superiority 检验Supplemental 增补的Supra-bioavailability 超生物利用度（试验药的生物利用度大于对照药）Survival analysis 生存分析System Audit 系统稽查SmPC：药品说明书Standard Sample：标准样品Target variable 目标变量Treatment group 试验组Trial error 试验误差Trial Initial Meeting 试验启动会议Trial 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Therapeutic equivalence：治疗等效性Un-blinding 破盲/揭盲Verify 查证、核实Visual analogy scale 直观类比打分法Vulnerable subject 弱势受试者Wash-out Period 洗脱期Well-being 福利，健康Withdraw 撤回，取消药代动力学参数Ae(0-t)：给药到t时尿中排泄的累计原形药。
临床研究常用术语英文对照
临床研究常用术语英文对照Glossary of Common Terms常用术语表Clinical Research临床研究Clinical research is medical research that involves people to test new treatments and therapies.临床研究是涉及人们测试新疗法和疗法的医学研究。
Clinical Trial临床试验A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.前瞻性地将一项或多项人类受试者分配给一项或多项干预措施（可能包括安慰剂或其他对照）的研究，以评估这些干预措施对健康相关的生物医学或行为结局的影响。
Healthy Volunteer健康志愿者(又称：健康受试者)A Healthy volunteer is a person with no known significant healthproblems who participates in clinical research to test a new drug, device, or intervention.健康志愿者是指没有已知重大健康问题的人，他们参与临床研究以测试新药，新设备或新干预措施。
Inclusion/Exclusion Criteria纳入/排除标准Inclusion/Exclusion Criteria are factors that allow someone to participate in a clinical trial are inclusion criteria. Those that exclude or not allow participation are exclusion criteria.纳入/排除标准是允许某人参加临床试验的因素，是纳入标准。
临床试验常用中英文词汇
SFDA Glossary：GCP，GLP，TRIAL Accuracy 准确度Active control，AC 阳性对照，活性对照Adverse drug reaction，ADR 药物不良反应Adverse event，AE 不良事件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 分段Block 层Block size 每段的长度BUN 尿素氮Carryover effect 延滞效应Case history 病历Case report form 病例报告表Case report form/ case record form，CRF 病例报告表，病例记录表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 偏差Documentation 记录／文件Dose-reaction relation 剂量－反应关系Double blinding 双盲Double dummy 双模拟Double dummy technique 双盲双模拟技术Double-blinding 双盲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/ measurement 终点指标Equivalence 等效性Essential documentation 必须文件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GC－FTIR 气相色谱－傅利叶红外联用GC－MS 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Good clinical practice，GCP 药物临床试验质量管理规范Good manufacture practice，GMP 药品生产质量管理规范Good non-clinical laboratory practice，GLP 药物非临床研究质量管理规范Group sequential 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Improvement 好转Inclusion criteria 入选标准Independent ethics committee，IEC 独立伦理委员会Information consent form，ICF 知情同意书Information gathering 信息收集Informed consent，IC 知情同意Initial meeting 启动会议Inspection 视察／检查Institution inspection 机构检查Institution review board，IBR 机构审查委员会Intention to treat 意向治疗（——临床领域）Intention-to –treat，ITT 意向性分析（－统计学）Interactive voice response system，IVRS 互动式语音应答系统Interim analysis 期中分析Investigator 研究者Investigator's brochure，IB 研究者手册IR 红外吸收光谱Ka 吸收速率常Last observation carry forward，LOCF 最接近一次观察的结转LC－MS 液相色谱－质谱联用LD50 板数致死剂量Logic check 逻辑检查LOQ （Limit of Quantitation）定量限LOCF，Last observation carry forward 最近一次观察的结转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 监查员Monitoring 监查Monitoring report 监查报告MRT 平均滞留时间MS 质谱MS－MS 质谱－质谱联用MTD（Maximum Tolerated Dose）最大耐受剂量Multicenter trial 多中心试验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-blinding 非盲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 variable 主要变量Principal investigator 主要研究者Principle investigator，PI 主要研究者Product license，PL 产品许可证Protocol 试验方案Protocol 试验方案Protocol amendment 方案补正Quality assurance unit，QAU 质量保证部门Quality assurance，QA 质量保证Quality control，QC 质量控制Query list，query form 应用疑问表Randomization 随机化Randomization 随机Range check 范围检查Rating scale 量表Regulatory authorities，RA 监督管理部门Replication 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 样本含量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Significant level 检验水准Simple randomization 简单随机Single blinding 单盲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 verification，SDV 原始数据核准Source data，SD 原始数据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Statistical analysis plan 统计参数计划书Statistical analysis plan，SAP 统计分析计划Statistical model 统计模型Statistical tables 统计分析表Stratified 分层Study audit 研究稽查Subgroup 亚组Sub-investigator 助理研究者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 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T1/2 消除半衰期Target variable 目标变量T－BIL 总胆红素T－CHO 总胆固醇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 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Unblinding 揭盲Unblinding 破盲Unexpected adverse event，UAE 预料外不良事件UV－VIS 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 清洗期Washout period 洗脱期Well-being 福利，健康。
临床试验中英对照词汇表english vocabulary of clinical trials
bind
BE
bioequivalence
BS
biostatistics
BSF
biostatistics study file
blank control
blind codes
blind review
blinding
blinding method
block
block size
BUN
blood urea nitrogen
central clinical file central ethics committee central investigator's file certified data analyst change order form chemistry manufacturing and controls chief media officer china food and drug administration circular dichroism clearance clinical auditor clinical data management system clinical director clinical equivalence clinical monitoring associate clinical monitoring/operations clinical project assistant clinical research associate clinical research coordinator clinical study clinical study documents clinical study report clinical trail management system clinical trial clinical trial agreement clinical trial application clinical trial assistant clinical trial exemption clinical trial protocol clinical trial supplies clinical trial/ study report cmax，maximum concentration co-inveatigator common technical document comparison complete response compliance composite variable computer-assisted trial design confidence interval confidence level confidentiality disclosure agreement consistency test contract research organization contract/ agreement control group controlled documents coordinating committee coordinating investigator corrective action & preventive action council for international organizations of medical sciences
临床试验常用中英文词汇
SFDA Glossary：GCP，GLP，TRIAL Accuracy 准确度Active control，AC 阳性对照，活性对照Adverse drug reaction，ADR 药物不良反应Adverse event，AE 不良事件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 分段Block 层Block size 每段的长度BUN 尿素氮Carryover effect 延滞效应Case history 病历Case report form 病例报告表Case report form/ case record form，CRF 病例报告表，病例记录表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Clinical trial application，CTA 临床试验申请Clinical trial exemption，CTX 临床试验免责Clinical trial protocol，CTP 临床试验方案Clinical trial/ study report 临床试验报告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 interval 可信区间Confidence level 置信水平Consistency test 一致性检验Contract research organization，CRO 合同研究组织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 偏差Documentation 记录／文件Dose-reaction relation 剂量－反应关系Double blinding 双盲Double dummy 双模拟Double dummy technique 双盲双模拟技术Double-blinding 双盲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/ measurement 终点指标Equivalence 等效性Essential documentation 必须文件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GC－FTIR 气相色谱－傅利叶红外联用GC－MS 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Good clinical practice，GCP 药物临床试验质量管理规范Good manufacture practice，GMP 药品生产质量管理规范Good non-clinical laboratory practice，GLP 药物非临床研究质量管理规范Group sequential 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Improvement 好转Inclusion criteria 入选标准Independent ethics committee，IEC 独立伦理委员会Information consent form，ICF 知情同意书Information gathering 信息收集Informed consent，IC 知情同意Initial meeting 启动会议Inspection 视察／检查Institution inspection 机构检查Institution review board，IBR 机构审查委员会Intention to treat 意向治疗（——临床领域）Intention-to –treat，ITT 意向性分析（－统计学）Interactive voice response system，IVRS 互动式语音应答系统Interim analysis 期中分析Investigator 研究者Investigator's brochure，IB 研究者手册IR 红外吸收光谱Ka 吸收速率常Last observation carry forward，LOCF 最接近一次观察的结转LC－MS 液相色谱－质谱联用LD50 板数致死剂量Logic check 逻辑检查LOQ （Limit of Quantitation）定量限LOCF，Last observation carry forward 最近一次观察的结转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 监查员Monitoring 监查Monitoring report 监查报告MRT 平均滞留时间MS 质谱MS－MS 质谱－质谱联用MTD（Maximum Tolerated Dose）最大耐受剂量Multicenter trial 多中心试验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-blinding 非盲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 variable 主要变量Principal investigator 主要研究者Principle investigator，PI 主要研究者Product license，PL 产品许可证Protocol 试验方案Protocol 试验方案Protocol amendment 方案补正Quality assurance unit，QAU 质量保证部门Quality assurance，QA 质量保证Quality control，QC 质量控制Query list，query form 应用疑问表Randomization 随机化Randomization 随机Range check 范围检查Rating scale 量表Regulatory authorities，RA 监督管理部门Replication 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 样本含量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Significant level 检验水准Simple randomization 简单随机Single blinding 单盲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 verification，SDV 原始数据核准Source data，SD 原始数据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Statistical analysis plan 统计参数计划书Statistical analysis plan，SAP 统计分析计划Statistical model 统计模型Statistical tables 统计分析表Stratified 分层Study audit 研究稽查Subgroup 亚组Sub-investigator 助理研究者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 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T1/2 消除半衰期Target variable 目标变量T－BIL 总胆红素T－CHO 总胆固醇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 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Unblinding 揭盲Unblinding 破盲Unexpected adverse event，UAE 预料外不良事件UV－VIS 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 清洗期Washout period 洗脱期Well-being 福利，健康。
临床试验英语词汇
专业术语、缩略语中英对照表缩略语英文全称中文全称ABE Average Bioequivalence 平均生物等效性AC Active control 阳性对照ADE Adverse Drug Event 药物不良事件ADR Adverse Drug Reaction 药物不良反应AE Adverse Event 不良事件AI Assistant Investigator 助理研究者ALB Albumin 白蛋白ALD Approximate Lethal Dose 近似致死剂量ALP Alkaline phosphatase 碱性磷酸酶ALT Alanine aminotransferase 丙氨酸转氨酶ANDA Abbreviated New Drug Application 简化新药申请ANOV A Analysis of variance 方差分析AST Aspartate aminotransferase 天冬氨酸转氨酶ATR Attenuated total reflection 衰减全反射法BA Bioavailability 生物利用度BE Bioequivalence 生物等效性BMI Body Mass Index 体质指数BUN Blood urea nitrogen 血尿素氮CATD Computer-assisted trial design 计算机辅助试验设计CDER Center of Drug Evaluation and Research 药品评价和研究中心CFR Code of Federal Regulation 美国联邦法规CI Co-Investigator 合作研究者CI Confidence Interval 可信区间COI Coordinating Investigator 协调研究者CRC Clinical Research Coordinator 临床研究协调者CRF Case Report/Record Form 病历报告表/病例记录表CRO Contract Research Organization 合同研究组织CSA Clinical Study Application 临床研究申请CTA Clinical Trial Application 临床试验申请CTP Clinical Trial Protocol 临床试验方案CTR Clinical Trial Report 临床试验报告CTX Clinical Trial Exemption 临床试验免责CHMP Committee for Medicinal 人用药委会Products for Human UseDSC Differential scanning 差示扫描热量计DSMB Data Safety and monitoring Board 数据安全及监控委员会EDC Electronic Data Capture 电子数据采集系统EDP Electronic Data Processing 电子数据处理系统EWP Europe Working Party 欧洲工作组FDA Food and Drug Administration 美国食品与药品管理局FR Final Report 总结报告GCP Good Clinical Practice 药物临床试验质量管理规范GCP Good Laboratory Practice 药物非临床试验质量管理规范GLU Glucose 葡萄糖GMP Good Manufacturing Practice 药品生产质量管理规范HEV Health economic evaluation 健康经济学评价IB Investigator’s Brochure研究者手册IBE IndividualBioequivalence 个体生物等效性IC Informed Consent 知情同意ICF Informed Consent Form 知情同意书ICH International Conference on Harmonization 国际协调会议IDM Independent Data Monitoring 独立数据监察IDMC Independent Data Monitoring Committee 独立数据监察委员会IEC Independent Ethics Committee 独立伦理委员会IND Investigational New Drug 新药临床研究IRB Institutional Review Board 机构审查委员会ITT Intention-to –treat 意向性分析IVD In Vitro Diagnostic 体外诊断IVRS Interactive Voice Response System 互动语音应答系统LD50 Medial lethal dose 半数致死剂量LLOQ Lower Limit of quantitation 定量下限LOCF Last observation carry forward 最接近一次观察的结转LOQ Limit of Quantitation 检测限MA Marketing Approval/Authorization 上市许可证MCA Medicines Control Agency 英国药品监督局MHW Ministry of Health and Welfare 日本卫生福利部MRT Mean residence time 平均滞留时间MTD Maximum Tolerated Dose 最大耐受剂量ND Not detectable 无法定量NDA New Drug Application 新药申请NEC New Drug Entity 新化学实体NIH National Institutes of Health 国家卫生研究所（美国）NMR Nuclear Magnetic Resonance 核磁共振PD Pharmacodynamics 药效动力学PI Principal Investigator 主要研究者PK Pharmacokinetics 药物动力学PL Product License 产品许可证PMA Pre-market Approval (Application) 上市前许可（申请）PP Per protocol 符合方案集PSI Statisticians in the Pharmaceutical Industry 制药业统计学家协会QA Quality Assurance 质量保证QAU Quality Assurance Unit 质量保证部门QC Quality Control 质量控制QWP Quality Working Party 质量工作组RA Regulatory Authorities 监督管理部门REV Revision 修订SA Site Assessment 现场评估SAE Serious Adverse Event 严重不良事件SAP Statistical Analysis Plan 统计分析计划SAR Serious Adverse Reaction 严重不良反应SD Source Data/Document 原始数据/文件SD Subject Diary 受试者日记SDV Source Data Verification 原始数据核准SEL Subject Enrollment Log 受试者入选表SFDA State Food and Drug Administration 国家食品药品监督管理局SI Sponsor-Investigator 申办研究者SI Sub-investigator 助理研究者SIC Subject Identification Code 受试者识别代码SOP Standard Operating Procedure 标准操作规程SPL Study Personnel List 研究人员名单SSL Subject Screening Log 受试者筛选表T&R Test and Reference Product 受试和参比试剂T－BIL Total Bilirubin 总胆红素T－CHO Total Cholesterol 总胆固醇TG Thromboglobulin 血小板球蛋白Tmax Time of maximum concentration 达峰时间TP Total proteinum 总蛋白UAE Unexpected Adverse Event 预料外不良事件WHO World Health Organization 世界卫生组织WHO- WHO International Conference WHO 国际药品管理当局会议ICDR A of Drug Regulatory AuthoritiesAberrant result 异常结果Absorption phase 吸收相Absorption 吸收Accuracy 准确度Accurate 精密度Administer 给药Amendment修正案Approval 批准Assess 估计Audit Report 稽查报告Audit 稽查Auditor 稽查员Analytical run/batch：分析批Benefit 获益Bias 偏性，偏倚Bioequivalence 生物等效Biosimilar /Follow-on biologics 生物仿制药Blank Control 空白对照Blind codes 编制盲底Blind review 盲态检查/盲态审核Blinding method 盲法Blinding/masking 盲法/设盲Block size 每段的长度Block 层/分段BCS 生物药剂学分类系统Carryover effect 延滞效应Case history 病历Clinical equivalence 临床等效性Clinical study 临床研究Clinical Trial Report 临床试验报告Comparison 对照Compensation 补偿，赔偿金Compliance 依从性Concomitant 伴随的Conduct 行为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Crossover design 交叉设计Cross-over Study 交叉研究Cure 痊愈Data management 数据管理Descriptive statistical analysis 描述性统计分析Dichotomies 二分类Dispense 分布Diviation 偏差Documentation 记录／文件Dosage forms 剂型Dose dumping 剂量倾卸（药物迅速释放入血而达到危险浓度）Dose-reaction relation 剂量－反应关系Double blinding 双盲Double dummy 双模Drop out 脱落Effectiveness 疗效Elimination phase 消除相Emergency envelope 应急信件Enantiomers 对映体End point 终点Endpoint criteria/ measurement 终点指标Enterohepatic recycling 肠肝循环Essential Documentation 必需文件Ethical 伦理的Ethics committee 伦理委员会Evaluate 评估Exclusion Criteria 排除标准Excretion 排泄Expedite 促进Extrapolated 外推的Essentially similar product：基本相似药物Factorial design 析因设计Failure 无效，失败Finacing 财务，资金Final point 终点First pass metabolism 首过代谢Fixed-dose procedure 固定剂量法Full analysis set 全分析集GC－FTIR 气相色谱－傅利叶红外联用GC－MS 气相色谱－质谱联用Generic drug 通用名药Gene mutation 基因突变Genotoxicity tests 生殖毒性试验Global assessment variable 全局评价变量Group sequential design 成组序贯设计Hypothesis test 假设检验Highly permeable：高渗透性Highly soluble：高溶解度Highly variable drug：高变异性药物Highly：Variable Drug 高变异性药物HVDP：高变异药物制剂Identification 鉴别，身份证Improvement 好转In vitro 体外In vivo 体内Inclusion Criteria 入选表准Information Gathering 信息收集Initial Meeting 启动会议Inspection 检察/视察Institution Inspection 机构检察Instruction 指令，说明Integrity 完整，正直Intercurrent 中间发生的，间发的Inter-individual variability 个体间变异性Interim analysis 期中分析Investigational Product 试验药物Investigator 研究者Involve 引起，包括IR 红外吸收光谱Innovator Product：原创药Ka 吸收速率常LC－MS 液相色谱－质谱联用logarithmic transformation 对数转换Logic check 逻辑检查Lost of follow up 失访Mask 面具，掩饰Matched pair 匹配配对Metabolism 代谢Missing value 缺失值Mixed effect model 混合效应模式Modified release products 改良释放剂型Monitor 监查员Monitoring Plan 监察计划Monitoring Report 监察报告MS－MS 质谱－质谱联用Multi-center Trial 多中心试验Negative 阴性，否定的Non-clinical Study 非临床研究Non-inferiority 非劣效性Non-Linear Pharmacokinetics 非线性药代动力学Non-parametric statistics 非参数统计方法NTID：窄治疗指数制剂Obedience 依从性Open-blinding 非盲Open-label 非盲Original Medical Record 原始医疗记录Outcome Assessment 结果评价Outcome measurement 结果指标Outlier 离群值OIP 经口服吸收药物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Permeability 渗透性Pharmacodynamic characteristics 药效学特征Pharmacokinetic characteristics 药代学特征Placebo Control 安慰剂对照Placebo 安慰剂Polytomies 多分类Post-dosing postures 给药后坐姿Potential 潜在的Power 检验效能Precision 精密度Preclinical Study 临床前研究Precursor 母体前体Premature 过早的，早发Primary endpoint 主要终点Primary variable 主要变量Prodrug 药物前体Protocol amendment 方案补正Protocol Amendments 修正案Protocol 试验方案Quality Control Sample：质控样品Rapidly dissolving：快速溶出Racemates 外消旋物Randomization 随机/随机化Range check 范围检Rating scale 量表Recruit 招募，新会员Replication 可重复Retrieval 取回，补修Revise 修正Risk 风险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Sampling schedules 采血计划Scale of ordered categorical ratings 有序分类指标Secondary variable 次要变量Sequence 试验次序Seriousness 严重性Severity 严重程度Significant level 检验水准Simple randomization 简单随机Single Blinding 单盲Site audit 试验机构稽查Solubility 溶解度Specificity 特异性Specify 叙述，说明Sponsor-investigator 申办研究者Standard curve 标准曲线Statistical model 统计模型Statistical tables 统计分析表Steady state 稳态Storage 储存Stratified 分层Study Audit 研究稽查Study Site 研究中心Subgroup 亚组Sub-investigator 助理研究者Subject Enrollment Log 受试者入选表Subject Enrollment 受试者入选Subject Identification Code List 受试者识别代码表Subject Recruitment 受试者招募Subject Screening Log 受试者筛选表Subject 受试者Submit 交付，委托Superiority 检验Supplemental 增补的Supra-bioavailability 超生物利用度（试验药的生物利用度大于对照药）Survival analysis 生存分析System Audit 系统稽查SmPC：药品说明书Standard Sample：标准样品Target variable 目标变量Treatment group 试验组Trial error 试验误差Trial Initial Meeting 试验启动会议Trial 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Therapeutic equivalence：治疗等效性Un-blinding 破盲/揭盲Verify 查证、核实Visual analogy scale 直观类比打分法Vulnerable subject 弱势受试者Wash-out Period 洗脱期Well-being 福利，健康Withdraw 撤回，取消药代动力学参数Ae(0-t)：给药到t时尿中排泄的累计原形药。
临床研究专业术语缩略语中英对照表
临床研究专业术语缩略语中英对照表研究领域日新月异，医学领域也不例外。
临床研究作为医学研究的重要组成部分，涉及到众多专业术语和缩略语，对于研究人员和医学学生来说，了解和掌握这些术语的中英对照表具有重要意义。
下面将为大家介绍一些常见的临床研究专业术语缩略语的中英对照表。
1. 临床研究常用术语- Randomized Controlled Trial (RCT)：随机对照试验- Informed Consent：知情同意- Double-blind：双盲- Placebo：安慰剂- Control Group：对照组- Experimental Group：实验组- Sample Size：样本量- Follow-up：随访- Protocol：方案- Ethics Committee：伦理委员会- Adverse Events：不良事件- Confidentiality：保密性2. 临床试验阶段术语临床试验一般分为四个阶段，每个阶段有其特定的目标和性质。
- Phase 1 Clinical Trial：一期临床试验- Phase 2 Clinical Trial：二期临床试验- Phase 3 Clinical Trial：三期临床试验- Phase 4 Clinical Trial：四期临床试验3. 常见疾病和症状在临床研究中，涉及到各种各样的疾病和症状的缩略语。
- AIDS：艾滋病- COPD：慢性阻塞性肺疾病- IBS：肠易激综合征- CAD：冠心病- MI：心肌梗死- CHF：充血性心力衰竭- TIA：短暂性脑缺血发作- PMS：经前紧张综合征- GERD：胃食管反流病- UTI：尿路感染- COPD：慢性阻塞性肺病- IBD：炎症性肠病- CVD：心血管疾病- CNS：中枢神经系统- RA：类风湿性关节炎4. 诊断工具缩略语在临床研究中，很多诊断工具和设备都有一些特定的缩略语。
- ECG：心电图- CT：计算机断层扫描- MRI：磁共振成像- PET：正电子发射计算机断层扫描- CBC：全血细胞计数- Pap Smear：宫颈抹片- EEG：脑电图- X-ray：X射线- EMG：肌电图- ABG：动脉血气分析- LFT：肝功能检查- BMP：基础血液检查- PSA：前列腺特异性抗原- CXR：胸部X射线- DEXA：双能X射线吸收法- MRA：磁共振血管成像5. 药物和治疗方法缩略语在临床研究中，药物和治疗方法也有很多缩略语。
临床试验常用中英文词汇
本文来源于西铁房临床试验爱好者中心（本帖最后发表人：西铁房管理员Admin)转载请保留此链接:http:351.pageSFDA Glossary：GCP，GLP，TRIALAccuracy准确度Active control，AC阳性对照，活性对照Adverse drug reaction，ADR药物不良反应Adverse event，AE不良事件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分段Block层Block size每段的长度BUN尿素氮Carryover effect延滞效应Case history病历Case report form病例报告表Case report form/ case record form，CRF病例报告表，病例记录表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Clinical trial application，CTA临床试验申请Clinical trial exemption，CTX临床试验免责Clinical trial protocol，CTP临床试验方案Clinical trial/ study report临床试验报告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 interval可信区间Confidence level置信水平Consistency test一致性检验Contract research organization，CRO合同研究组织Contract/ agreement协议／合同Control group对照组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偏差Documentation记录／文件Dose-reaction relation剂量－反应关系Double blinding双盲Double dummy双模拟Double dummy technique双盲双模拟技术Double-blinding双盲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/ measurement终点指标Equivalence等效性Essential documentation必须文件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GC－FTIR气相色谱－傅利叶红外联用GC－MS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Good clinical practice，GCP药物临床试验质量管理规范Good manufacture practice，GMP药品生产质量管理规范Goodnon-clinicallaboratorypractice，GLP药物非临床研究质量管理规范Group sequential 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Improvement好转Inclusion criteria入选标准Information consent form，ICF知情同意书Information gathering信息收集Informed consent，IC知情同意Initial meeting启动会议Inspection视察／检查Institution inspection机构检查Institution review board，IBR机构审查委员会Intention to treat意向治疗（——临床领域）Intention-to–treat，ITT意向性分析（－统计学）Interactive voice response system，IVRS互动式语音应答系统Interim analysis 期中分析Investigator研究者Investigator's brochure，IB研究者手册IR红外吸收光谱Ka吸收速率常Last observation carry forward，LOCF最接近一次观察的结转LC－MS液相色谱－质谱联用LD50板数致死剂量Logic check逻辑检查LOQ（Limit of Quantitation）定量限LOCF，Last observation carry forward最近一次观察的结转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监查员Monitoring监查Monitoring report监查报告MRT平均滞留时间MS质谱MS－MS质谱－质谱联用MTD（Maximum Tolerated Dose）最大耐受剂量Multicenter trial多中心试验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-blinding非盲Open-label非盲Optional titration随意滴定Original medical record原始医疗记录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 variable主要变量Principal investigator主要研究者Principle investigator，PI主要研究者Product license，PL产品许可证Protocol试验方案Protocol试验方案Protocol amendment方案补正Quality assurance unit，QAU质量保证部门Quality assurance，QA质量保证Quality control，QC质量控制Query list，query form应用疑问表Randomization随机化Randomization随机Range check范围检查Rating scale量表Regulatory authorities，RA监督管理部门Replication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样本含量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Significant level检验水准Simple randomization简单随机Single blinding单盲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 verification，SDV原始数据核准Source data，SD原始数据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Statistical analysis plan统计参数计划书Statistical analysis plan，SAP统计分析计划Statistical model统计模型Statistical tables统计分析表Stratified分层Study audit研究稽查Subgroup亚组Sub-investigator助理研究者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 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T1/2消除半衰期Target variable目标变量T－BIL总胆红素T－CHO总胆固醇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 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Unblinding揭盲Unblinding破盲Unexpected adverse event，UAE预料外不良事件UV－VIS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清洗期Washout period洗脱期Well-being福利，健康西铁房国际临床试验爱好者中心http:。
FDA临床试验常见词汇中译文对照
FDA临床试验常见词汇中译文对照Aaction letter 决定通知active comparator 活性药物对照组active control = AC 阳性对照，活性对照active ingredient 有效成分Active Substance Master File (ASMF) 欧洲药物主文件acute myocardial infarction 急性心肌梗死acute tibial fractures 急性胫骨骨折adalimumab (Humira) 阿达木单抗adaptive design 自适应设计adaptive randomization 自适应随机ADE = adverse drug event 药物不良事件Adenoviral Vectors 腺病毒载体adequate and well-controlled studies 充分严格的对照研究ADHD = Attention-deficit hyperactivity disorder注意力缺陷多动障碍; 注意力不足过动症; 多动症adhesion barrier product 防黏著产品adjuvant 助剂; 佐剂auxiliary;adjuvant therapy 佐药疗法，辅助疗法ADL = activities of daily living 日常生活活动能力ADME = absorption, distribution, metabolism, and excretion(药物)吸收、分配、代谢和排除ADR = adverse drug reaction 药物不良反应adrenal cortex 肾上腺皮质adrenal cortical hormone 肾上腺皮质激素adrenal gland 肾上腺adrenaline 肾上腺素adulterated devices 掺假器械adverse drug reaction = ADR药物不良反应adverse effect 副作用adverse event = AE 不良事件adverse medical events 不良医学事件adverse reaction (adverse event) 药物不良反应advisory 提醒advocacy and support groups 倡导和支持团体AE = adverse event 不良事件AERS = Adverse Event Reporting System 不良事件报告系统BBIMO Bioresearch Monitoring Program 生物研究监测bioavailability (F) 生物利用度biochemical drugs 生化药品biocides 生物杀灭剂; 杀生物剂biocompatibility 生物相容性biodegradable 生物分解bio-engineered, transgenic food 转基因食物bioequivalence; bioequivalent 生物等效应biofilm 细菌薄膜, 生物膜biologic 生物制品biological response modifiers BRM 生物应答调节剂biological therapeutic agents 生物治疗药剂biomarker 生物标志物biometrics 生物统计; 生物识别技术bion stimulator 生物体刺激器bionic knee 仿生膝关节biopharma: biopharmaceutical products 生物药物产品bipolar 双相燥郁症birth defect 出生缺陷, 新生儿缺陷, 先天缺陷BLA = biologic license application 生物制品许可申请blank control 空白对照blend uniformity analysis 混合均匀度分析blind 盲法blind codes 编制盲底blind review 盲态审核blinding method 盲法blinding/ masking 盲法，设盲blister packaging 泡罩包装; 水泡眼block 分段;层block size 每段的长度blocked randomization 区组随机Ccase history 病历case record form = CRF病例报告表/病例记录表case report form 病例报告表cash curve 现金曲线cash trap 现金陷阱; 现金套牢categorical variable 分类变量CLIA Clinical Laboratory Improvement Amendments临床实验室改进修订案clinical (human) data 临床数据clinical endpoint临床终点clinical equivalence 临床等效应clinical hold 临床试验暂停通知clinical investigator 临床研究者Clinical Pharmacists 临床药师Clinical Research Coordinator = CRC临床研究协调者clinical study 临床研究Clinical Study Application = CSA临床研究申请clinical study report 临床试验的总结报告clinical trial 临床试验clinical trial application = CTA 临床试验申请clinical trial exemption = CTX 临床试验免责clinical trial protocol = CTP 临床试验方案Clinical Trial Report = CTR临床试验报告clinically significant results 有临床意义cohort 队列cohort studies 队列研究co-investigator = CI合作研究者comparison 对照Compassionate Use 体恤使用competitive labeling 优越标签Complementary And Alternative Therapy 补充性和非传统治疗Complete response 完全有效compliance 遵守；对遵守法规情况的监管composite variable 复合变量Compression Test 压缩试验computer-assisted trial design= CATD计算机辅助试验设计Con Meds = concomitant medications 联合用药confidence interval 可信区间confidence level 置信水平Confidentiality Regarding Trial Participants 为试验参与者保密control对照control group 对照组controlled clinical trials 临床对照实验Controlled Trials 对照试验Critical Path 关键路径CRM = continual reassessment method 连续重新评估方法crossover design 交叉设计cross-over study 交叉研究crossover therapy 交叉治疗CRF = case report form 病例报告表dosage form 剂型dosage regimen 给药方案dose-ranging study 剂量范围研究dose-reaction relation 剂量－反应关系dose-related adverse reactions 剂量相关的不良反应double blinding 双盲double dummy 双模拟double dummy 双模拟double dummy technique 双盲双模拟技术double-blind study 双盲研究Double-Masked Study 双盲研究DRGs = Diagnosis Related Group System 疾病诊断相关分组drop out 脱落drop test 落震试验;跌落试验drug eluting coronary stents 药物洗脱支架drug product 药物产品drug substance 原料药drug-drug interaction56 药物-药物相互作用drug-food interaction 药物-食物的相互作用EEPS = Electronic Entry Processing System 电子录入处理系统effectiveness 疗效efficacy 有效性测定efficacy (Of a drug or treatment) 药效；药品疗效EEMEA = European Medical Evaluation Agency; European Agency for the Evaluation of Medicinal Products; European Medicines Agency 药物评价机构; 欧洲医药品管理局emergency envelope 应急信件Empiric Bayesian Multiple Gamma-Poisson Shrinker经验性贝氏法（伽玛泊松分布缩检法）empirical 经验性endpoint 终点endpoint criteria 终点指标factorial design 析因设计factorial trial 析因试验failure 无效，失败Fair Packaging and Labeling Act (1966) 公平包装和标签法False Claims Act 防制不实请求法false therapeutic claims 错误的疗效声明full analysis set 全分析集full factorial design 全因子试验法Iinclusion criteria 入选标准inclusion/exclusion criteria 入选/排除标准incremental exposure 食品中递增摄入量incubation period/latency period 潜伏期IND = Investigational New Drug 临床研究新药INDA = investigational new drug application NDA前申报阶段indemnity insurance 赔偿保险Independent Data Monitoring = IDM独立数据监察Independent Data Monitoring Committee = IDMC独立数据监察委员会independent ethics committee = IEC 独立伦理委员会indications 适应症investigational new drug = IND 临床研究新药investigational product 试验药物investigator 调研人员investigator's brochure = IB 研究者手册Mmasked 设盲mean absorption time = MAT(药物在体内的)平均吸收时间mean disintegration time = MDIT(药物在体内的)平均崩解时间Mean Dissolution Time = MDT (药物在体内的)平均释放时间Mean Residence Time = MRT(药物在体内的)平均滞留时间medical governance 医药治理Medicare 老年医疗保险制度；联邦老年医保medication guides (for patients) 用药指南Medicines Control Agency = MCA英国药品监督局Misbranding 错误标签; 冒牌Miscoding 编码错误missing value 缺失值mixed effect model 混合效应模式MLD = minimal lethal dose 最小致死剂量MoA = Mechanism of Action 作用机制;作用机理monitor 监查员monitoring plan监查计划monitoring report 监查报告MR = moderate response 好转MRA = Agreement on Mutual Recognition 相互承认协定MTD = maximal tolerance dose 最大耐受剂量multicenter trial 多中心试验multi-drug resistance 多药物抗药性multiple arm trials 多治疗组的试验mutual recognition procedure (EU) 相互承认程序OOS = Overall survival 总生存率Pparallel group design 平行组设计parameter estimation 参数估计parametric release 参数放行parametric statistics 参数统计方法patient file 病人档案patient global; pt global 病人总体评价patient history 病历per protocol ( PP) analysis 符合方案分析PFS = progression-free survival 无疾病进展存活率PGE = patient global evaluation 病人总体评价PHA = preliminary hazards analysis 预先危险分析pharmaceutical equivalence 药剂等效性pharmaceutics药剂学pharmacodynamics=PD 药物效应动力学; 简称药效学pharmacoepidemiology 药物流行病学pharmacokinetics = PK 药代动力学; 简称药动学pharmacology 药理学Pharmacovigilance105 药物警戒pharmacy 配药学PharMetrics claims database 索赔数据库PhRMA = Pharmaceutical Research and Manufacturers of America美国药物研究与生产商协会PIC=Pharmaceutical Inspection Convention 药品检查协定PIC/S Pharmaceutical Inspection Cooperation Scheme 药物检查合作计划pipeline assets 开发中产品PK = pharmacokinetics 药物代谢动力学; 药动学，药代动力学placebo 安慰剂placebo control 安慰剂对照placebo controlled study 安慰剂对照研究placebo effect 安慰剂效应PMA = premarket approval 上市前许可; 销售前批准PMCs = post marketing commitments 承诺药品上市后的继续研究PMDRA = Post Marketing Drug Risk Assessment 上市后药品风险评估(办公室) PMHx = Past Medical History 既往病史PMN = Premarket Notification 销售前通知PMS = Premenstrual syndrome 经前综合症POC (Proof-of-concept) Clinical Trials 概念证明POC = point-of-care testing 床旁分析polytomies 多分类pooled analysis = PA 荟萃分析postmarket surveillance 上市后监督post-marketing surveillance; postmarket safety surveillance 销售（上市）后监督power 把握度; 检验效能Pp = Process Performance 工序绩效Ppk = Process Performance Index 工序绩效指数precautions 慎用；注意事项precision 精密度preclinical (animal) data 临床前(动物实验)数据preclinical study 临床前研究predicate device = legally marketed device that is not subject to Premarket Approval (PMA)和已合法在市场上销售的且不需要做PMA“销售前批准”的Pre-market Approval (Application) = PMA上市前许可（申请）premarket notification 上市前通知pre-marketing surveillance 销售（上市）前监督preparing and submitting 起草和申报prescription drug 处方药preservation 保藏prevalence 患病率prevention trials预防试验primary (coronary) event 原位病变primary endpoint 主要终点primary mode of action = PMOA 首要作用模式primary variable 主要变量principal investigator = PI主要研究者Principles of Qualification 确认（验证）原则process controls 工艺控制process validation 工艺验证product codes 产品的号码product differentiation 产品差异化，产品特色化product license = PL 产品许可证product life cycle (PLC) 产品生命周期prognosis 预后progression-free survival = PFS 无进展生存progressive Disease PD 病情进展proof of principle study 原理循证研究propensity score 倾向性评分protocol 试验方案; 方案protocol amendment 方案补正prototype design 原型设计protozoa 原生动物门proven acceptable Range = PAR 确定可接受范围PTC = Product Technical Complaints 药品技术投诉Qqualification system for licensed pharmacist 执业药师资格准入制度qualified health claims 有保留的健康宣称Qualified Person = QP 受权人quality assurance = QA质量保证quality assurance unit = QAU质量保证部门quality control = QC 质量控制quality management systems 质量管理体系quality of life trials or supportive care trials 生存质量试验quality risk management = QRM 质量风险管理quantitative risk assessment 量化风险评估Rrandomization 随机化randomized trial 随机化试验randomized, double blinded clinical trial 随机双盲对照研究range check 范围检查rating scale 量表RCT = randomized clinical trials 随机临床试验RCT = randomized controlled trial 随机对照试验RDE: remote data entry 远距数据输入ready-to-eat foods 即食食品reagents 试剂recall 召回; 强制回收RECIST = Response Evaluation Criteria in Solid Tumors 实体瘤的疗效评价标准reconditioning 整改; 货物重整理；货物重包装recycled plastics 可循环利用塑料制品reference product 参比制剂reference samples 标准样品regulatory methodology 质量管理方法regulatory methods validation 管理用分析方法的验证（FDA对NDA提供的方法进行验证）regulatory specification 质量管理规格标准（NDA提供）rejection 排异remote monitoring system 远程监测系统; 远程监控REMS = Risk Evaluation and Mitigation Strategies 风险评估和减缓战略risk 受害risk assessment (risk analysis + risk evaluation) 风险评估，论证risk classification 风险分类;Risk Communications Advisory Committee 风险交流咨询委员会risk evaluation (part of risk assessment) 风险评价risk/ benefit analysis 风险-获益分析risk-benefit ratio 效益/风险比route of administration 给药途径royalties 专利使用费RPN = Risk Priority Number 风险优先指数RR = Response rate 缓解率RSD = (intra-day and inter-day) relative standard deviations (日内和日间) 相对标准差Ssafety advisory 安全建议safety evaluation 安全性评价safety evaluators 安全性评估人员safety set 安全性评价的数据集screening trials 筛选性试验SD = standard deviation 标准(偏)差SE = substantial equivalence 实质上的等同Seal Strength Test 密封强度试验sequence 试验次序SFDA 129= State Food And Drug Administration 国家食品药品监督管理局SG & A= Sales, General and Administration 销售、管理和一般费用shaft 传动轴SHEA = Society for Healthcare Epidemiology of America 美国医院流行病学学会sheaths 护套shelf life 保存期限; 保质期SIC codes = Standard Industrial Classification codes 标准产业分类代码side effects 副作用significance level 显著性水平Significant Risk (SR) 显著的危险性simple randomization 简单随机simulation model 仿真模型single blinding单盲single-blind study 单盲研究single-masked study 单盲研究site assessment = SA现场评估site audit 试验机构稽查SMDA = Safe Medical Devices Act of 1990 1990年安全医疗器械法SMF = Site Master File 生产场所主文件sNDA = supplemental NDA 疗效补充新药上市申请sponsor-investigator = SI 申办研究者spontaneous reports; voluntary reports 药品不良反应自愿报告SPS = Agreement on the Application Of Sanitary and Phytosanitary Measures卫生与植物卫生措施实施协议;简称SPS协议SSI = surgical site infection 手术部位感染SSOPs = Sanitation Standard Operating Procedures 卫生标准操作程序standard curve 标准曲线standard deviation 标准偏差standard drug 标准药物standard operating procedure = SOP 标准操作规程standard treatment 标准治疗Standards Of Care131 医护标准State Food and Drug Administration = SFDA国家食品药品监督管理局statistic 统计量statistical analysis plan = SAP 统计分析计划statistical model 统计模型statistical significance 统计学意义statistical tables 统计分析表Statisticians in the Pharmaceutical Industry = PSI制药业统计学家协会steady-state Area Under the Curve = AUCss稳态药时曲线下面积/稳态血药浓度－时间曲线下面积stratified 分层study audit 研究稽查study endpoint 研究终点Study Personnel List = SPL研究人员名单study site研究中心study type 研究类型subchronic toxicity studies 亚慢性毒性研究subgroup 亚组sub-investigator 助理研究者subject 受试者subject diary = SD 受试者日记subject enrollment 受试者入选subject enrollment log = SEL受试者入选表Subject Identification Code List = SIC受试者识别代码表subject recruitment 受试者招募subject screening log = SSL受试者筛选表submission 申报；递交subspecialties, internal medicine 亚专科,内科substantial equivalence to legally marketed (predicate) device 和已合法在市场上销售的且不需要做PMA“销售前批准”的相似产品有实质上的等同Ttrain-the-trainer program 培训者培训计划treatment group 试验组treatment IND 治疗性试验性新药申请treatment trials 治疗性试验trial error 试验误差trial initial meeting 试验启动会议trial master file 试验总档案trial objective 试验目的trial site 试验场所TRICARE 军队医疗系统triple blinding 三盲two one-side test 双单侧检验UAE = unexpected adverse event 预料外不良事件unblinding 破盲;揭盲under reporting bias 少报偏差unexplained syncope 不明原因晕厥unresectable 不能手术切除variability 变异variable 变量WHO International Collaborating Center for Drug Monitoring(世界卫生组织)国际药物监测合作中心WHO International Conference of Drug Regulatory Authorities= WHO-ICDRAWHO国际药品管理当局会议WHO Programme for International Drug Monitoring = PIDMWHO 国际药物监测合作计划。
临床试验相关词汇中英对照
临床试验词汇中英文对照Accuracy 准确度Active control，AC 阳性对照，活性对照Adverse drug reaction，ADR 药物不良反应Adverse event，AE 不良事件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 分段Block 层Block size 每段的长度BUN 尿素氮Carryover effect 延滞效应Case history 病历Case report form 病例报告表Case report form/ case record form，CRF 病例报告表，病例记录表Categorical variable 分类变量Cav 平均浓度CD 圆二色谱CL（clearance）清除率Clinical equivalence 临床等效性Clinical study 临床研究Clinical study report 临床试验的总结报告Clinical trial 临床试验Clinical trial application，CTA 临床试验申请Clinical trial exemption，CTX 临床试验免责Clinical trial protocol，CTP 临床试验方案Clinical trial/ study report 临床试验报告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 interval 可信区间Confidence level 置信水平Consistency test 一致性检验Contract research organization，CRO 合同研究组织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 稳态浓度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 偏差Documentation 记录／文件Dose-reaction relation 剂量－反应关系Double blinding 双盲Double dummy 双模拟Double dummy technique 双盲双模拟技术Double-blinding 双盲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/ measurement 终点指标Equivalence 等效性Essential documentation 必须文件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GC－FTIR 气相色谱－傅利叶红外联用GC－MS 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Good clinical practice，GCP 药物临床试验质量管理规范Good manufacture practice，GMP 药品生产质量管理规范Good non-clinical laboratory practice，GLP 药物非临床研究质量管理规范Group sequential 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Improvement 好转Inclusion criteria 入选标准Independent ethics committee，IEC 独立伦理委员会Information consent form，ICF 知情同意书Information gathering 信息收集Informed consent，IC 知情同意Initial meeting 启动会议Inspection 视察／检查Institution inspection 机构检查Institution review board，IBR 机构审查委员会Intention to treat 意向治疗（——临床领域）Intention-to –treat，ITT 意向性分析（－统计学）Interactive voice response system，IVRS 互动式语音应答系统Interim analysis 期中分析Investigator 研究者Investigator's brochure，IB 研究者手册IR 红外吸收光谱Ka 吸收速率常Last observation carry forward，LOCF 最接近一次观察的结转LC－MS 液相色谱－质谱联用LD50 板数致死剂量Logic check 逻辑检查LOQ （Limit of Quantitation）定量限LOCF，Last observation carry forward 最近一次观察的结转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 监查员Monitoring 监查Monitoring report 监查报告MRT 平均滞留时间MS 质谱MS－MS 质谱－质谱联用MTD（Maximum Tolerated Dose）最大耐受剂量Multicenter trial 多中心试验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-blinding 非盲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 variable 主要变量Principal investigator 主要研究者Principle investigator，PI 主要研究者Product license，PL 产品许可证Protocol 试验方案Protocol 试验方案Protocol amendment 方案补正Quality assurance unit，QAU 质量保证部门Quality assurance，QA 质量保证Quality control，QC 质量控制Query list，query form 应用疑问表Randomization 随机化Randomization 随机Range check 范围检查Rating scale 量表Regulatory authorities，RA 监督管理部门Replication 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 样本含量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Significant level 检验水准Simple randomization 简单随机Single blinding 单盲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 verification，SDV 原始数据核准Source data，SD 原始数据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Statistical analysis plan 统计参数计划书Statistical analysis plan，SAP 统计分析计划Statistical model 统计模型Statistical tables 统计分析表Stratified 分层Study audit 研究稽查Subgroup 亚组Sub-investigator 助理研究者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 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T1/2 消除半衰期Target variable 目标变量T－BIL 总胆红素T－CHO 总胆固醇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 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Unblinding 揭盲Unblinding 破盲Unexpected adverse event，UAE 预料外不良事件UV－VIS 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 清洗期Washout period 洗脱期Well-being 福利，健康临床采血相关词汇Intravenous injection(IV) 静脉注射Intravenous drip/Intravenously guttae(iv gtt)静脉滴注intramscular injection(IM) 肌内注射intradermal injections 皮内注射subcutaneous injections（SC）皮下注射disposable sterile injector 一次性无菌注射针injection set注射器disposable venous infusion needle一次性静脉输液针disposable infusion set 一次性使用输液器blood transfusion set输血器infusion bag液袋urine drainage bag集尿袋blood bag血袋medical catheter医用导管stainless steel needle不锈钢医用针管blood taking needle/ blood collection needle采血针Needle Holder 持针器Blood samples血样样本sample drawing/collection 采血/抽血needles 针vacutainer needles真空采血针tubes导管vacutainer tubes 真空管vacutainer holder 真空持针器tourniquet 止血带disinfection swabs 消毒海绵micropore tapedental rollsadhesive dressing 胶布敷料rubber gloves 橡皮手套pillow 枕头stopper 塞子（采血管的塞子）vacuum tubes真空管non-vacuum tubes 非真空管needle disposal box 穿刺针处理盒（利器处理盒）transfer and storage tubes 转移和存储管pipette 吸管吸液管移液管disposable pipettes一次性使用吸管centrifuge离心机swinging bucket rotor 浮桶式转头、吊桶式转头timer 计时器racks for tubes 试管架identification codes识别码mark/label the tubes标记导管freeze冷冻refrigerator 冰箱freezer 冰箱冷冻机Serum Separation Tube 血清分离试管Serum血清Plasma血浆whole blood 全血be inverted 倒垂的倒置的clot 凝块凝结Coagulate 凝固凝结clotting time 凝血时间minimally 最低限度地最低程度地maximally 最高限度地最高程度地Separation of serum or plasma 分离血清或血浆Hemolysis 溶血hemolyzed samples 溶血样本assays 含量测定analysis 分析（名词）analyze 分析（动词）analyzing 分析（动名词）non-frozen samples 非冷冻样本chemistry laboratories化学实验室Analytical procedures 分析程序Qualification 资质资格Personnel in the laboratory 实验室人员Field personnel 现场工作人员Internal quality control 内部质量控制External quality control 外部质量控制Hepatitis B 乙肝Hepatitis C 丙肝Positive 阳性Negative 阴性Measurement 测量pulse rate 脉搏Blood pressure 血压systolic blood pressure 收缩压diastolic blood pressure 舒张压hypertensives 高血压hypotension 低血压antihypertensive drug 抗高血压药mercury sphygmomanometer 水银式血压计mercury column 水银柱serum total cholesterol 血清总胆固醇lipid lowering drug 降脂药Obesity 肥胖症Blood Glucose 血糖BMI (body mass index) 体重指数Overweight 超重sample size 样本大小statistically 统计上地，统计地statistical precision 统计精度sub-groups亚群Recruitment招募Ethical 伦理的道德的Legal 法律的合法的Data in electronic format 电子版数据back-up data 备查资料常用临床医学英文术语cough 咳嗽asthma 哮喘pneumonia 肺炎heart disease 心脏病arrhythmia 心律不齐indigestion 消化不良gastritis 胃炎appendicitis 盲肠炎hepatitis 肝炎dermatitis皮炎freckle/ephelis 痣，雀斑acne 粉刺flu 流感diarrhoea 痢疾quarantine 检疫vaccinate 打疫苗endemic 水土不服relapse 复发症casualty急症stupor 昏迷sprain 扭伤scalding 烫伤graze 擦伤scratch 搔挠trauma 外伤bruise 淤伤fracture骨折dislocation 脱臼tinnitus耳鸣trachoma沙眼colour blindness 色盲nearsightedness/myopia近视astigmatism 散光gingivitis 牙龈炎cavity 龋齿fever 发烧discomfort/disorder 不适malnutrition 营养不良incubation 潜伏期asthenia 虚弱poisoning 中毒fatigue 疲劳heat stroke 中暑itching 发痒ache/pain 痛tetanus 破伤风night sweat 盗汗chill 打冷颤pale 脸色发白shuddering 发抖inflammation 炎症acute 急症chronic 慢性病congenital 先天性病nausea恶心vomit 呕吐diseases 疾病acute diseases 急性病advanced diseases 病沉重期，晚期疾病chronic diseases慢性病communicable diseases 传染病complicating diseases 并发病congenital diseases 先天性疾病acquired diseases 后天性疾病contagious diseases接触性传染病endemic diseases 地方病epidemic diseases 流行病functional diseases 机能病、官能病infectious diseases 传染病inherited diseases 遗传病malignant diseases恶性病nutritional diseases 营养病occupation diseases 职业病organic diseases 器质性病paroxysmal diseases 阵发性病periodical diseases 周期病primary（principal）diseases原发（主导）病secondary diseases 继发病sexual（venereal, social）diseases 性病terminal diseases 绝症wasting diseases 消耗性疾病chief complaint 主诉clinical manifestation 临床表现delivery history 分娩史etiology病因学family history 家族史history, medical history 病史precipitating（induced）诱因marital status婚姻状况menstrual history 月经史menarche 初潮menopause闭经past history既往史pathogenesis 发病机制personal history 个人史symptoms 症状cardinal symptom 主要症状classical symptom 典型症状concomitant symptom 伴发症状constitutional（systemic）symptom 全身症状indirect symptom 间接症状induced symptom 诱发症状local symptom 局部症状mental symptom精神症状symptom-complex （syndrome）symptom 综合症，症候群signs体征antecedent 前驱征assident （accessory）副征commemorative 后遗症sign of death 死征diagnostic诊断征sign of disease 病征subjective 自觉征，主观征vein sign静脉征vital sign 生命体征body length （height of the body）身高body weight 体重barrel chest 桶状胸cachexia 恶病质compulsive position 被动体位critical facies 病危面容emaciation 消瘦enophthalmos 眼球下陷entropion 睑内翻exophthalmos 眼球突出flushed face 面色潮红gain （loss）in weight 增加（减轻）体重lock-jaw 牙关紧闭lordosis 脊柱前凸nasal ala flap 鼻翼扇动nystagmus 眼震obesity 肥胖pallor 苍白scolisis 脊柱侧凸agitation 焦急不安debility, weakness 虚弱diaphoresis 出汗，大量出汗dizziness, vertigo 眩晕lassitude, fatigue 无力，倦怠malaise 不适night sweat 盗汗numbness 麻木rigor, chill 寒冷，发冷perspiration, sweating 出汗pruritus, itching 痒，somasthenia 躯体无力tingling 麻刺感abscess 脓肿acidosis 酸中毒adhesion 粘连alkalosis 碱中毒allergy 过敏coagulation defect 凝血不良congestion 充血dehydration 脱水distention 膨胀edema 水肿embolism 栓塞，栓塞形成fluid and electrolyte imbalance 水电解质紊乱gangrene 坏疽hematoma 血肿hemorrhage, bleeding 出血infarction 梗塞，梗死infection 传染inflammation 炎症ketoacidosis 酮酸中毒metastasis 转移perforation 穿孔necrosis 坏死shock 休克response 反应，应答reaction 反应，感应thrombosis 血栓形成ulceration 溃疡fever, pyrexia 发烧，发热continuous fever 稽留热intermittent fever 间歇热low-grade fever 低热remittent fever 驰张热relapsing fever 回归热pain 痛burning pain 灼痛chest（flank,…）pain 胸（胁腹…）痛cramp-like pain 痉挛性痛dull, diffused pain 弥漫性钝痛pleuritic pain 胸膜炎性痛radiating pain （pain radiating to…）放射性痛（放射到…疼痛）angina 绞痛cardiac angina 心绞痛backache 背痛colic 绞痛，急腹痛earache 耳痛headache 头痛neuralgia 神经痛migraine 偏头痛rebound tenderness 反跳痛somatalgia 躯体痛sore throat 咽喉痛stomachache 胃痛toothache 牙痛bloody sputum 带血的痰cough 咳嗽dry cough 干咳expectoration 咳痰expectoration of blood 咳血hemoptysis 咳血anoxia 缺氧apnea 呼吸暂停，窒息asthma 气喘，哮喘Cheyne Stokes respiration 切－斯氏呼吸，潮式呼吸dyspnea 呼吸困难hyperpnea hyperventilation 过度呼吸，换气过度hypopnea 呼吸不全，呼吸浅表hypoxia 低氧，缺氧orthopnea 端坐呼吸respiratory arrest 呼吸停止suffocation 窒息tachypnea 呼吸急促fetid breath 口臭fruity breath 呼吸有水果味arrhythmia 心律失常，心律不齐atelectasis 肺不张，肺膨胀不全cardiac arrest 心搏骤停cardiac hypertrophy 心脏肥大cyanosis 发绀，青紫distension of jugular vein 颈静脉怒张extrasystole 期外收缩gallop rhythm 奔马律hemopleura 血胸hepatojugular reflux 肝颈静脉回流hypovolemia （循环）血容量减少palpitation 心悸tachycardia 心动过速pneumothorax 气胸thrill 震颤absent breath sounds 呼吸音消失dull sound 浊音hyperresonant 鼓音rale 啰音rhonchus, rhonchi 鼾音，干啰音wheeze 哮鸣音anorexia, loss of appetite 食欲不振，厌食dysphagia 吞咽困难eructation 嗳气belching 嗳气flatulence 气胀flatus 肠胃气，屁gaseous distention 胃胀气hematemesis 呕血hiccough, hiccup 打呃，呃逆nausea 恶心pyrosis 胃灼热regurgitation 反胃，回流thirsty 口渴vomiting 呕吐anal fissure, crack in the anal canal 肛裂ascites 腹水board-like rigidity of the abdomen 板状腹decreased tactile fremitus 触觉性震颤减弱exophageal varices 食管静脉曲张fistula 瘘，瘘管hemorrhoid 痔hernia 疝hepatomegaly 肝肿大intussusception 肠套叠jaundice 黄疸muscle guarding, defence of the abdominal wall 腹壁肌卫peristalsis 蠕动loss of peristalsis 蠕动消失mass peristalsis 总蠕动retrograde （reversed）peristalsis 逆蠕动prolapse 脱垂prolapse of anus 脱肛rectal prolapse 直肠脱垂，脱肛volvulus 肠扭转calculus 结石，石biliary calculus 胆结石vesical calculus 膀胱结石constipation 便秘defecation 排便diarrhea 腹泻incontinence of feces 大便失禁hematochezia 便血fecal impaction 大便嵌塞occult blood 潜血painful straining with defecation 排便痛性牵动clay colored stools 陶土色便dark, granular/coffee ground emesis 咖啡样呕吐物fecal vomiting, stercoraceous vomiting 呕粪，吐粪foul fatty stools, steatorrhea 恶臭脂肪便，脂肪痢scanty and hard stools 便少而硬tarry （black）stools 柏油样便anuria 无尿burning sensation no urination 排尿时的灼烧感dysurea 排尿困难，尿痛enuresis, bed wetting 遗尿frequency of urination 尿频micturation 排尿uresis, urination, voiding 排尿nocturia 夜尿oliguria 少尿polyuria 多尿tenesmus 里急后重vesical tenesmus 排尿时里急后重uremia coma 尿毒症昏迷urgency of urination 尿急urinary incontinence 尿失禁aciduria 酸尿chyluria 乳糜尿cylindruia 管型尿glycosuria 糖尿hematuria 血尿ketonuria 酮尿pneumatinuria 气尿proteinuria 蛋白尿pyuria 脓尿amenorrhea 经闭，无月经dysmenorrhea 痛经menorrhagia 月经过多lochia 恶露menorrhea 行经，月经过多menstruation 月经uterine contraction 子宫收缩blotch 斑点bruise 挫伤，青肿acne 痤疮，粉刺desquamation 脱皮，脱屑ecchymosis 瘀斑loss of skin turgor 失去皮肤充盈nevus 痣papule 丘疹petechia 瘀点，瘀斑pigmentation 色素沉着pustule 脓疱purpura 紫癫red nodule 红结节roseola 玫瑰疹scar 伤疤senile plaque 老人斑spider anaioma 蛛形痣subcutaneous nodule 皮下结节urticaria 荨麻疹vesicle 小水疱vitiligo 白斑blindness 失明blurred vision, visual disturbance 视力模糊impaired vision 视力下降lacrimation 流泪papilledema 视神经乳头水肿photophobia 畏光，羞明retinal detachment 视网膜脱离deafness 聋hearing loss 听力丧失tinnitus 耳鸣epistaxis, nasal bleeding 鼻出血impaired smelling 嗅觉障碍nasal discharge 鼻涕nasal obstruction 鼻塞sneeze 喷嚏snore 打鼾aphonia, loss of voice 失音症hoarseness 嘶哑gum bleeding 齿龈出血herpes labialis 唇疱疹，感冒疮Koplik's spots 科普利克斑lead line of the gum 龈铅线salivation, drooling 流口水straw-berry tongue 草莓舌tremulous tongue 舌震颤atrophy 萎缩contracture 挛缩deformity 畸形，变形dislocation 脱位fracture 骨折closed （simple）fracture 无创骨折，单纯性骨折comminuted fracture 粉碎性骨折compound fracture 哆开（开放性）骨折knock-knee 膝外翻opisthotonos 角弓反张prosthesis 假体spasm 痉挛tetany （肌）强直，手足抽搦wrist drop 腕下垂aphasia 失语ataxia 共济失调coma 昏迷consciousness 知觉，意识convulsion 抽搐，惊厥delirium 谵妄delusion 妄想faint 昏厥hallucination 幻觉hemiplegia 偏瘫increased intracranial pressure 颅内压增高insanity 精神错乱loss of orientation 定向丧失mania 躁狂memory defects, amnesia 记忆缺损，遗忘症paraplegia 截瘫，下身麻痹projectile vomiting 喷射性呕吐somnolence, （lethargy）昏睡，嗜睡stupor 木僵，昏呆tetraplegia 四肢瘫痪unconsciousness 失去知觉yawning 打哈欠crisis 危象cerebral （febrile, hematic, hemolytic,hypertensiv e, thyrotoxic, ……）crisis脑（热、血性、溶血、高血压、甲状腺中毒…）危象failure 衰竭，故障centra（circulatory, cardiac, myocardiac, peripheral, congestive, renal, respiratory）failure中枢（循环、心力、心肌、周围循环、充血性、肾、呼吸…）衰竭diagnosis诊断auscultation 听诊inspection 视诊palpation触诊percussion 叩诊laboratory examination 实验室检查physical examination 体格检查rectal （vaginal）touch 直肠（阴道）指诊impression 印象tentative diagnosis 暂定诊断differential diagnosis 鉴别诊断final diagnosis 最后诊断prognosis 预后prescription 处方incubation （latent）period 潜伏期prodromal stage 前驱期incipient stage 初期quiescent stage 静止期alleviation 减轻，缓和remission 缓解attack 发作convalescence （recovery）stage 恢复期rehabilitation 康复relapse 复发sudden death 猝死moribund 濒死的course of the disease 病程course of the treatment 疗程indication 适应症，指征complication 并发症contraindication 禁忌症side-effect 副作用sequel （sequela）, after effect 后遗症therapies 治疗方法acupuncture therapy 针刺疗法block therapy 封闭疗法chemical therpy （chemo-therapy）化学疗法combined therapy 综合疗法conservative therapy 保守疗法constitutional therapy 全身疗法dietetic therapy 饮食疗法operative treatment 手术疗法palliative treatment, alleviative treatment 姑息疗法physical therapy 物理疗法psychotherapy 精神疗法radical treatment 根治radio-therapy 放射性疗法supporting treatment 支持疗法symptomatic treatment对症疗法cardiac massage 心脏按摩cardiac pacing 心脏起博electrotherapy 电疗法electroshock treatment 电休克疗法hemodialysis 血液透析hyperbaric therapy 高压氧疗法insulin-shock treatment 胰岛素休克疗法light therapy 光疗法Urine Analyzer 尿液分析仪blood sugar（glucose ）analyzer血糖分析仪test strip 测试条reagent 试剂Semi-automatic Biochemical Analyzer半自动生化分析仪Automatic Blood Cell Analyzer全自动血细胞分析仪Urine sediments analyzer尿沉渣Bio-safety Cabinet 生物安全柜Incubator培养箱High Frequency Electrotome 高频电刀shadowless lamp无影灯High speed refrigerated centrifuge高速冷冻离心机hot air sterilizer热空气消毒箱microbiological incubator微生物培养箱Halogen light 卤素灯needle destroyer针头销毁器automatic packer自动纸塑包装机scalp vein set头皮针uniprocessor version单机版network version网络版macromolecule-solvent 高分子溶解的macromolecule cold accumulation 高分子蓄冷cold treatment冷疗法ice pack冰袋eyeshade 眼罩Medical injection pump医用灌注泵lithotrite 碎石机extracorporeal shock wave lithotrite体外冲击碎石机Ballistic intracroporeal lithotrite 气压冲击体内碎石机Laparoscope 腹腔镜Urology 泌尿外科kidney stones 肾结石Multi-parameter monitor, 多参数监护仪maternal monitor/fetal monitor母亲/胎儿监护仪ICU monitor 重症监护仪anesthetic equipment 麻醉机respirator呼吸机electronic colposcope 电子阴道镜smog absorber烟雾吸收器digital film room 数字胶片室Permanent Magnet Open Magnetic Resonance system 永磁开放式磁共振系统Ultrasonic Color Doppler Diagnostic system彩色超声多普勒诊断系统Mobile CT system 移动CT系统X-ray Mammary Machine 乳腺X线机Mammography乳腺high precision Stereotaxic 高精度脑立体定向仪portable Type-B ultrasonic 便携式B超Sterilization and Disinfection Equipment消毒灭菌设备Radiotherapeutic equipment.放射疗法设备pharmaceutical equipments.制药设备horizontal pressurized steam sterilizer普通卧式压力蒸汽灭菌器medical electronic linear accelerator医用电子直线加速器high frequency X-rays diagnostic machine高频X射线诊断机simulated positioner模拟定位机high frequency mobile X-rays machine高频移动X射线机医疗卫生人员职衔职称主任医师（讲课）：Professor of Medicine主任医师（医疗）：Professor of Treatment儿科主任医师：Professor of Paediatrics主治医师：Doctor-in-charge外科主治医师：Surgeon-in-charge内科主治医师：Physician-in-charge眼科主治医师：Oculist-in-charge妇科主治医师：Gynaecologist-in-charge牙科主治医师：Dentist-in-charge医师：Doctor医士：Assistant Doctor主任药师：Professor of Pharmacy主管药师：Pharmacist-in-charge药师：Pharmacist药士：Assistant Pharmacist主任护师：Professor of Nursing主管护师：Nurse-in-charge护师：Nurse Practitioner护士：Nurse主任技师：Senior Technologist主管技师：Technologist-in-charge技师：Technologist技士：Technician常用抗菌药物青霉素类青霉素(G) Penicillin(G) Benzylpenicillin, 苄青霉素, 盘尼西林青霉素V Penicillin V Phenoxymethylpenicillin, Blinvan, Ospen, 苯氧甲基青霉素苄星青霉素Benzathine Penicillin 长效西林, 长效青霉素, 比西林, LPG, 苄星青氨苄西林Ampicillin 安比西林, 氨苄青霉素, 安必仙, 安必林, 安比林阿莫西林Amoxicillin 特力士, 弗来莫星, 羟氨苄青霉素, 益萨林, 阿莫仙, 安福喜, 本原莫星巴氨西林Bacampicillin 美洛平, 氨卡西林, 氨苄青霉素甲戊酯阿洛西林Azlocillin 阿乐欣, 咪氨苄西林, 氧咪苄青霉素, Azlin美洛西林Mezlocillin 天林, Baypen, Mezlin, Baycipen替卡西林Ticarcillin 羧噻吩青霉素, 的卡西林, Nonapen, Ticarpen酞氨西林Talampicillin 氨苄青霉素酞酯, 酞氨苄青霉素, 酞氨苄西林, TAPC, Talpen夫苄西林Furbenicillin 呋脲苄青霉素, 呋苄青霉素, 呋氨西林, 呋喃酰脲苄青霉素氟氯西林Flucloxacillin 氟氯苯唑青霉素, 氟沙星, 福氯平, Floxapen羧苄西林Carbenicillin 羧苄青霉素, 卡比西林, 羧苄青阿扑西林Aspoxicillim 天冬羟氨青霉素, Doyle, ASPC匹氨西林Pivampicillin 氨苄西林酯, 匹凡西林, 匹呋西林, 吡呋氨卡西林双氯西林Dicloxacillin 双氯青, Dynapen, Consaphyl, Stampen, Diflor甲氧西林Meticillin 新青霉素Ⅰ, 美替西林, Azapen, Penysol苯唑西林钠Oxacillin Sodium 新青霉素Ⅱ, 苯唑青霉素钠, 苯甲异噁唑青霉素奈夫西林Nafcillin 新青霉素Ⅲ, 乙氧萘青霉素匹美西林Pivmecillinam 氮卓咪青霉素双酯, Celfuron, Melysin仑氨苄西林Lenampicillin Varacillin, Takacillin美西林Mecillinam Selexidleo, Selexid, Coactin, Amdinocillin, 氮卓脒青霉素哌拉西林钠Piperacillin Sodium 氧哌嗪青霉素, 哔哌西林, 哌氨苄青霉素Avocin, Orocin, Pipril氯唑西林钠Cloxacillin Sodium 邻氯青霉素钠, 氯唑青, Orbenin阿帕西林钠Apalcillin Sodium 萘啶青霉素钠, APPC, Lumota, Elumota, Palcin磺苄西林钠Sulbenicillin Sodium 磺苄青霉素钠, 卡他西林, 格达西林Sulfocillin, Lilacillin, Kedacillin青霉素V钾Phenoxymethylpenicillin Potassiume 6–苯氧乙酰胺基青霉烷酸钾, Cillaphen Distaquaine VK, Compocillin VK, Dowpen VK Cilicaine VK, Apopen, Biopen海他西林钾Hetacillin Potassium 缩酮氨苄青霉素钾, Etacillin, Veisapen卡茚西林钠Carindacillin Sodium Carbenicillin Indanyl Sodium, Geopen, Geocillin 治平霉素替莫西林二钠Temocillin Disodium Temopen头孢菌素类第一代头孢噻吩钠Cefalotin Sodium 先锋Ⅰ号, 头孢金素, 噻孢霉素, CET头孢噻啶Cefaloridine 先锋Ⅱ号, 头孢利素, CER, Kafspor头孢来星Cefaloglycine 先锋Ⅲ号, 头孢甘酸, Kafocin, Kefglycin头孢氨苄Cefalexin 先锋Ⅳ号, 苯甘孢霉素, 头孢力新, CEX头孢唑啉钠Cefazolin Sodium 先锋Ⅴ号, 塞福宁, 西华乐林, 先锋啉, 凯复唑Cefalin, CEX, Cefamedin, Kefzol, Cramaxin头孢拉定Cefradine 先锋Ⅵ号, 头孢雷定, 头孢瑞丁, 头孢环已烯，泛捷复, Velosef, CED, 塞福定头孢乙腈Cefacetrile 先锋Ⅶ号, 头孢腈甲, 头孢赛曲头孢匹林Cefapirin 先锋Ⅷ号, 头孢吡硫, Ceta-Dri头孢硫脒Cefathiamidine 先锋18, 吡脒头孢头孢克洛Cefaclor 赐福乐素, 新达乐, 头孢氯氨苄, Ceclor, 希刻劳，头孢克罗, 可福乐, 氯头孢菌素, CCL头孢羟氨苄Cefadroxil Cefadril, Kefroxil, 羟氨苄头孢菌素, 欧意, CDX，Duracef, Bidocef, Cefamx头孢沙定Cefroxadine 头孢环烯氨, ORASPON, CGP-9000, CXD头孢罗齐Cefprozil 头孢丙烯, Cefzil头孢替唑Ceftezole 特子社复, Tezacef, Alomen第二代头孢呋辛钠Cefuroxime Sodium 头孢呋肟, 赐福乐信, 舒贝洛, 西力欣, 特力欣, 明可欣, CXM, Zinacef, Monacef, Ketocef, Furex Kesiut, Supero头孢替安Cefotiam 噻乙胺唑头孢菌素, 头孢噻乙胺唑, 泛司博林, 泛司颇灵, Pansparin, Halospor, CTM头孢呋辛酯Cefuroxime Axetil 头孢呋肟酯, 新菌灵, 西力达, 头孢呋新乙酰乙酯Zinnat头孢西丁Cefoxitin 头孢氧唑, 甲氧头霉噻吩, 噻吩甲氧头孢菌素, 美福仙, 甲氧头霉噻吩, CXT, CFX头孢尼西二钠Cefonicid Disodium 铭乐希, Monocid, Cefonicid, Cefodie, Cefol头孢孟多Cefamandole 头孢羟唑, 羟苄四唑头孢菌素, Mandolkef, CMT, Cefadole, Mandol头孢美唑钠Cefmetazole Sodium 先锋美他醇, 氰唑甲氧头孢菌素, 头孢氰四唑,头孢美他唑, CEFMETAZON, CMZ, Cemetol头孢布宗Cefbuperazone 头孢拉宗, Keiperazon, Tomiporan, Cefobutazine, CBPZ 头孢雷特Ceforanide 头孢氨甲苯唑, 头孢苄胺四唑, 氨苄唑头孢菌素Precef第三代头孢地尼Cefdinir Cefzon头孢布坦Ceftibuten 头孢布烯, Cedax头孢卡品Cefcapene Pivoxil 头孢卡喷新戊酰氧甲酯, Flomox头孢噻肟钠Cefotaxime Sodium 头孢氨噻肟, 泰可欣, 塞福隆, 菌必灭, 治菌必妥, 凯福隆, 凯复龙, 头孢噻肟, 喜福得, Claforan, CTX头孢曲松钠Ceftriaxone Sodium 头孢三嗪, 头孢泰克松, 罗氏芬, 罗噻嗪, 菌必治, 菌得治, 头孢三嗪噻肟, 泛生舒复, 西华瑞隆, Rocephin, Ro-139904, CTRX 头孢哌酮钠Cefoperazone Sodium 头孢氧哌唑, 先锋必, 头孢必, 达诺欣, 塞福必，Cefobid, T-1551, CPZ头孢他啶Ceftazidime 头孢塔齐定, 头孢羧甲噻肟, 复达欣, 凯复定, Glazidine, Fortaz, Eposerin, Modocin, Fotrum, Tazidime, CTZ, Spectrum, Eposerin, Modocin头孢唑肟Ceftizoxime 头孢去甲噻肟, 益保世灵, 安保速灵, Epocelin CZX, CEFTIZOX头孢克肟Cefixime 头孢烯噻羟肟, 世伏素, 世福素, FK027, Suprax, CFIX , CEFSPAN头孢甲肟Cefmenoxime 头孢氨噻肟唑, 倍司特克, BESTCALL, CMX头孢地嗪Cefodizime 头孢双唑, 莫敌, 莫敌威, Modivid, Timcef头孢匹胺Cefpiramide 先福吡兰, 甲吡唑头孢菌素, 头孢吡胺, CPM，Cefpiran, Sepatren头孢特仑酯Cefteram Pivoxil 头孢特仑新戊酰氧甲酯, 托米仑, 头孢他美酯，富山龙, Tomiron头孢磺吡苄钠Cefsulodin Sodium 头孢磺吡酮, 头孢磺啶钠, 磺吡苄头孢菌素钠，达克舒林, Cefsulodine, Takesulin, CFS, SCE129拉他头孢Latamoxef 羟羧氧酰胺菌素, 拉氧头孢, 头孢拉坦, 噻吗灵Moxalactam, Shiomarin, Moxam, LMOX头孢米诺Cefminox 氨羧甲氧头孢菌素, 美土灵, Meicelin头孢咪唑Cefpimizole Benilan, SPIE, Ajicef头孢替坦二钠Cefotetan Disodium 双硫唑甲氧头孢霉素, Yamatetan, CTT, Cefotan第四代头孢唑喃钠Cefuzonam Sodium Cosmosin, CZON氟氧头孢钠Flomoxef Sodium 氟莫克西, 6315-S头孢匹罗Cefpirome 头孢吡隆, 氨噻肟吡戊头孢其它Β-内酰胺类亚胺培南Imipenem 伊米配能, 亚胺硫霉素, NFT氯曲南Aztreonam 菌克单, 君刻单, 噻肟单酰胺菌素, AZACTAM，Primbactam, Primbactin, SQ-26776氟罗培南Faropenem 福劳派南, Farom苄西林/氯唑西林Ampicillin/Cloxacillin 复方安比西林, 爱罗苏, 氨氯西林, 白罗仙, 淋必清, Pinocine亚胺培南/西司他丁Imipenem/Cilastatin 亚胺硫霉素/西拉司丁, 泰能, TIENAM, PRIMAXIN阿莫西林/氟氯西林Amoxicillin/Flucloxacillin 氟羟西林, 新灭菌, Biflocin, Infectrin三羟阿莫西林/单羟双氯西林Amoxycillin Trihydrate/Dicloxacillin康彼身, 克菌, CompliscanΒ-内酰胺类抗生类+Β-内酰胺酶抑制剂氨苄西林/舒巴坦Ampicillin/Sulbactam 强力安必仙, 舒他西林, 优力新, 新凯兰欣, 舒氨欣, Unasyn, Sultamicillin头孢哌酮/舒巴坦Cefoperazone/Sulbactam 舒普深, 舒哌酮, Sulperazone头孢噻肟/舒巴坦Cefotaxime/Sulbactam 新治菌哌拉西林/他佐巴坦Piperacillin/Tazobactam Tazocin, YP-14阿莫西林/克拉维酸Amoxillin/Clavulanic Acid 安灭菌, 安美汀, 奥格门汀, 安美汀, 阿莫克拉Augmentin, BRL25000替卡西林/克拉维酸Ticarcillin/Clavulanic Acid 泰门汀, 特泯菌, 特美汀, Timentin舒巴坦Sulbactam 舒巴克坦, 陪他美, 青霉烷砜氨基糖甙类链霉素Streptomycin RIMACTANE, RIFAMPINN, ovostrep庆大霉素Gentamycin 庆大霉素C, 瑞贝克, 正泰霉素庆大霉素链Gentamicin Chains 塞透派勒链, Septopal妥布霉素Tobramycin 立可信软膏，点必舒眼药水（妥布＋地塞米松）泰星，妥布拉霉素，托普霉素，NEBCIN，Factorb, Brulamycin, Tobra, Nebramycin, Gernebcin, Obracine小诺霉素Micronomicin 小诺米星, 沙加霉素, 相模霉素, Sagamicin, Kw-1062, MCR核糖霉素Ribostamycin 威他霉素, 维生霉素, Vistamycin, Ibistacin大观霉素Spectinomycin 奇霉素, 壮观霉素, 淋必治, 奈毒素, Spectram, 克淋, Trobicin, Kirin阿米卡星Amikacin 丁胺卡那霉素, Amikin, Likacin西索米星Sisomicin 西梭霉素, 西索霉素, 紫苏霉素, Sisomin, Sipeptin奈替米星Netilmicin 乙基西梭霉素, 奈特, 奈替霉素, 乙基西素米星, 立克菌星, 乙基紫苏毒素, Ethylsisomicin, Vectacin, Zetamicn, Certomycin, NETROMYCIN异帕米星Isepamicin 依克沙霉素, HAPA-B, Exacin阿司米星Astromicin 阿司霉素, 福提霉素, 武夷霉素, 强壮霉素FORTIMICIN, Kw-1070, ASTM, Fortimicin地贝卡星Dibekacin 双去氧卡那霉素B, Dideoxykanamycin B, DKB, 达苄霉素, Icacine依替米星Etimicin 悉能磷霉素类磷霉素Fosfomycin 福赐美仙, Phosphonomycin, Fosfocina, FOＭ磷霉素氨基丁三醇Fosfomycin Tromethamine Monurol喹诺酮类第二代吡哌酸Pipemidic Acid PPA第三代诺氟沙星Nofloxacin 氟哌酸, 淋克星, Fulgram, Noroxin, AM-715 MK-0366, Brazan, Baccidal环丙沙星Ciprofloxacin 悉复欣, 悉普欣, 悉普宁, 丽珠环丙, 特美力，环丙氟哌酸, 健宝灵, CIPRO, Bay-0-9867, Ciprobay, Ciproxin培氟沙星Pefloxacin 培福新, 甲氟哌酸, 倍泰, Peflacine洛美沙星Lomefloxacin 洛威, 罗氟酸, 欣美罗, 多龙, Bareon芦氟沙星Rufloxacin 如氟沙星左旋氧氟沙星Levofloxacin 可乐必妥, 左氟沙星, Cravit依诺沙星Enoxacin 氟啶酸, 福禄马, 复克, FLUMARK, GYRAMID，Flumark氟罗沙星Fleroxacin 复诺定, 多氟哌酸, 喹诺敌, 麦加乐定, 沃尔得FLX, Megelone, Quinodis, Ro-236240, AM-833氧氟沙星Ofloxacin 氟嗪酸, 秦利必妥, 泰利特, 奥复星, 康泰必妥, 竹安新, TARIVID, 赞诺欣, Zanoxin, Oflocin, 泰利得, 正康培氟沙星Pefloxacin 甲氟哌酸, 培氟哌酸, 培福新, 倍宁, Pefalcine。
FDA,GMP,ICH临床实验专业英语词汇互译
FDA,GMP,ICH临床实验专业英语词汇互译FDA,GMP,ICH临床实验专业英语词汇互译FDA常用词中英对照FDA(food and drug adminisration)美国)食品药品监督管理局NDA(new drug application):新药申请ANDA(abbreviated new drug application):简化新药申请EP(export application):出口药申请(申请出口不被批准在美国销售的药品)treatment IND:研究中的新药用于治疗abbreviated(new)drug:简化申请的新药DMF(drug master file):药物主文件(持有者为谨慎起见而准备的保密资料,可以包括一个或多个人用药物在制备,加工,包装和贮存过程中所涉及的设备,生产过程或物品.只有在DMF 持有者或授权代表以授权书的形式授权给FDA,FDA在审查IND, NDA,ANDA时才能参考其内容)holderMF持有者CFR(code of federal regulation)美国)联邦法规PANEL:专家小组batch production:批量生产;分批生产batch production records:生产批号记录post or pre-market surveillance:销售前或销售后监督informed consent:知情同意(患者对治疗或受试者对医疗试验了解后表示同意接受治疗或试验)prescription drug:处方药OTC drug(over—the—counter drug):非处方药U.S. public health service:美国卫生福利部NIH(national institute of health)美国)全国卫生研究所animal trail:动物试验accelerated approval:加速批准standard drug:标准药物investigator :研究人员;调研人员preparing and submitting:起草和申报submission:申报;递交benefit(s):受益risk(s):受害drug product:药物产品drug substance:原料药established name:确定的名称generic name:非专利名称proprietary name:专有名称;INN(international nonproprietary name):国际非专有名称narrative summary: 记叙体概要adverse effect:副作用adverse reaction:不良反应protocol:方案archival copy:存档用副本review copy:审查用副本official compendium:法定药典(主要指USP, NF).USP(the united state pharmacopeia):美国药典(现已和NF合并一起出版)NF(national formulary)美国)国家药品集official=pharmacopeial = compendial:药典的;法定的;官方的agency:审理部门(指FDA)sponsor:主办者(指负责并着手临床研究者)identity:真伪;鉴别;特性strength:规格;规格含量(每一剂量单位所含有效成分的量)labeled amount:标示量regulatory specification:质量管理规格标准(NDA提供)regulatory methodology:质量管理方法(FDA用于考核原料药或药物产品是否符合批准了的质量管理规格标准的整套步骤)regulatory methods validation:管理用分析方法的验证(FDA对NDA提供的方法进行验证)Dietary supplement:食用补充品ICH(International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use)人用药物注册技术要求国际协调会议ICHuality-质量Q1A(R2): Stability Testing of New Drug Substances and Products (Second Revision)新原料药和制剂的稳定性试验(第二版)Q1B: Photostability Testing of New Drug Substances and Products新原料药和制剂的光稳定性试验Q1C: Stability Testing for New Dosage Forms新制剂的稳定性试验Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products原料药和制剂稳定性试验的交叉和矩阵设计Q1E: Evaluation of Stability Data对稳定性数据的评估处理Q1F: Stability Data Package for Registration Applications in Climatic Zones III and IV在气候带III和IV,药物注册申请所提供的稳定性数据Q2A: Text on Validation of Analytical Procedures分析程序的验证Q2B: Validation of Analytical Procedures: Methodology分析程序的验证:方法学Q3A(R): Impurities in New Drug Substances (Revised Guideline)新原料药中的杂质(修订版)Q3B(R): Impurities in New Drug Products (Revised Guideline)新制剂中的杂质(修订版)Q3C: Impurities: Guideline for Residual Solvents杂质:残留溶剂指南Q3C(M): Impurities: Guideline for Residual Solvents (Maintenance)杂质:残留溶剂指南(修改内容)Q4: Pharmacopoeias药典Q4A: Pharmacopoeial Harmonisation 药典的协调Q4B: Regulatory Acceptance of Pharmacopoeial Interchangeability药典互替在法规上的可接受性Q5A: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin来源于人或者动物细胞系的生物技术产品的病毒安全性评估Q5B: Quality of Biotechnological Products: Analysis of the Expression Construct in Cells Used for Production of r-DNA Derived Protein Products生物技术产品的质量:源于重组DNA的蛋白质产品的生产中所用的细胞中的表达构建分析Q5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products生物技术产品的质量:生物技术/生物产品的稳定性试验Q5D: Derivation and Characterisation of Cell Substrates Used for Production of Biotechnological/Biological Products用于生产生物技术/生物产品的细胞底物的起源和特征描述Q5E: Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process基于不同生产工艺的生物技术产品/生物产品的可比较性Q6: Specifications for New Drug Substances and Products新原料药和制剂的质量规格Q6A: Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances质量规格:新原料药和新制剂的检验程序和可接收标准:化学物质Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products质量规格:生物技术/生物产品的检验程序和可接收标准-- 作者:月萝兰魂-- 发布时间:2006-12-22 13:34:00--Q7: Good Manufacturing Practices for Pharmaceutical Ingredients活性药物成份的GMPQ7A: Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients活性药物成份的GMP指南Q8: Pharmaceutical Development药物研发Q9: Quality Risk Management质量风险管理ICH:Safety-安全S1A: Guideline on the Need for Carcinogenicity Studies of Pharmaceuticals药物致癌性研究需要的指南S1B: Testing for Carcinogenicity of Pharmaceuticals药物致癌性的检验S1C: Dose Selection for Carcinogenicity Studies of Pharmaceuticals药物致癌性研究之剂量选择S1C(R): Addendum: Addition of a Limit Dose and Related Notes附录:极限剂量和有关注释的的补充S2A: Guidance on Specific Aspects of Regulatory Genotoxicity Tests for Pharmaceuticals受法规管辖的药物基因毒性检验的特定方面的指南S2B: Genotoxicity: A Standard Battery for Genotoxicity Testing for Pharmaceuticals 基因毒性:药物基因毒性检验的标准S3A: Note for Guidance on Toxicokinetics: The Assessment of Systemic Exposure in Toxicity Studies毒物代谢动力学指南的注释:毒性研究中的全身性暴露量的评估S3B: Pharmacokinetics: Guidance for Repeated Dose Tissue Distribution Studies药物代谢动力学:重复剂量的组织分布研究指南S4: Single Dose Toxicity Tests单剂量毒性检验S4A: Duration of Chronic Toxicity Testing in Animals (Rodent and Non-Rodent Toxicity Testing)动物体内慢性毒性持续时间的检验(啮齿动物和非啮齿动物毒性检验)S5A: Detection of Toxicity to Reproduction for Medicinal Products药物对生殖发育的毒性的检验S5B(M): Maintenance of the ICH Guideline on Toxicity to Male Fertility: An Addendum to the Guideline on Detection of Toxicity to Reproduction for Medicinal Products 对男性生殖能力的毒性的指南的变动:药物对生殖发育的毒性的检验指南增加了一个附录S6: Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals生物技术生产的药物的临床前安全评价S7A: Safety Pharmacology Studies for Human Pharmaceuticals人用药的安全药理学研究S7B: The Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization(QT Interval Prolongation) By Human Pharmaceuticals药物延迟心室复极化(QT间期)潜在作用的非临床评价S8: Immunotoxicology Studies for Human Pharmaceuticals人用药免疫毒理学研究M3(M): Maintenance of the ICH Guideline on Non-Clinical Safety Studies for the Conduct of Human Clinical Trials for Pharmaceuticals药物的对人临床试验的非临床安全研究指南的变动E-Efficacy(有效)E1: The Extent of Population Exposure to Assess Clinical Safety for Drugs Intended for Long-Term Treatment of Non-Life-Threatening Conditions对用于无生命危险情况下长期治疗的药物进行临床安全评估的族群暴露量范围E2A: Clinical Safety Data Management: Definitions and Standards for Expedited Reporting临床安全数据管理:速报制度的定义和标准E2B(R): Revision of the E2B(M) ICH Guideline on Clinical Safety Data Management Data Elements for Transmission of Individual Case Safety Reports个案安全报告送交的临床安全数据管理的数据要素指南(E2B(M))的修订版E2B (M): Maintenance of the Clinical Safety Data Management including: Data Elements for Transmission of Individual Case Safety Reports临床安全数据管理的变动包括:个案安全报告送交的数据要素E2B(M): Maintenance of the Clinical Safety Data Management including Questions and Answers临床安全数据管理的变动,包括问答E2C: Clinical Safety Data Management: Periodic Safety Update Reports for Marketed Drugs临床安全数据管理:已上市药品的周期性安全数据更新报告Addendum to E2C: Periodic Safety Update Reports for Marketed DrugsE2C的附录:已上市药品的周期性安全数据更新报告E2D: Post-Approval Safety Data Management: Definitions and Standards for Expedited Reporting批准后的安全数据管理:速报制度的定义和标准E2E: Pharmacovigilance Planning药物警戒计划E3: Structure and Content of Clinical Study Reports临床研究报告的结构和内容E4: Dose-Response Information to Support Drug Registration支持药品注册的剂量-效应资料E5: Ethnic Factors in the Acceptability of Foreign Clinical Data引入海外临床数据时要考虑的人种因素E6: Good Clinical Practice: Consolidated GuidelineGCP:良好的临床规范:统一的指南E7: Studies in Support of Special Populations: Geriatrics对特定族群的支持的研究:老人病学E8: General Considerations for Clinical Trials对临床试验的总的考虑E9: Statistical Principles for Clinical Trials临床试验的统计原则E10: Choice of Control Group and Related Issues in Clinical Trials临床试验中控制组和有关课题的选择E11: Clinical Investigation of Medicinal Products in the Pediatric Population小儿科药物的临床调查E12A: Principles for Clinical Evaluation of New Antihypertensive Drugs新抗高血压药物的临床评价原则E14: The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs非抗心率失常药物的QT/QTc 间期和致心率失常潜在作用的临床评价Multidisciplinary Guidelines 多学科兼容的指南M1: Medical Terminology医学术语M2: Electronic Standards for Transmission of Regulatory Information (ESTRI)药政信息传递之电子标准M3: Timing of Pre-clinical Studies in Relation to Clinical Trials (See Safety Topics)有关临床试验的临床前研究的时间安排M4: The Common Technical Document (See CTD section for complete Status of the guidelines)通用技术文件(见有关CTD章节)M5: Data Elements and Standards for Drug Dictionaries药物词典的数据要素和标准临床试验常用的英文缩略语TTP: time-to-progression 疾病进展时间SAE: severity Adverse Event 严重不良事件AE: Adverse Event 不良事件-- 作者:月萝兰魂-- 发布时间:2006-12-22 13:34:00--SOP: Standard Operating Procedure 标准操作规程CRF: Case Report form 病例报告表DLT: 剂量限制毒性MTD: 最大耐受剂量KPS: Karnofsky Performance Status行为状态评分CR: complete response完全缓解PR: partial response部分缓解SD: 病情稳定PD: progressive disease病情进展CTC: 常用药物毒性标准IEC: independent ethics committee 独立伦理委员会IRB : institutional review board 伦理委员会CRA: 临床研究助理CRO: Contract Research Organization 合同研究组织DFS: Disease Free Survival 无病生存期OS: (Overall Survival) 总生存时间IC: Informed consent 知情同意ADR: Adverse Drug Reaction 不良反应GAP:Good Agricultural Practice 中药材种植管理规范GCP:Good Clinical Practice 药物临床试验质量管理规范GLP:Good Laboratory Practice 药品实验室管理规范GMP:Good Manufacturing Practice 药品生产质量管理规范GSP:Good Supply Practice 药品经营质量管理规范GUP:Good Use Practice 药品使用质量管理规范PI rincipal investigator 主要研究者CI: Co-inveatigator 合作研究者SI :Sub-investigator 助理研究者COI :Coordinating investigtor 协调研究者DGMP: 医疗器械生产质量管理规范ICF: Informed consent form 知情同意书RCT : randomized controlled trial, 随机对照试验NRCCT: non-randomized concurrent controlled trial, 非随机同期对照试验EBM: evidence-based medicine 循证医学RCD: randomized cross-over disgn 随机交叉对照试验HCT: historial control trial, 历史对照研究RECIST: Response Evaluation Criteria In Solid Tumors. 实体瘤疗效反应的评价标准QC: Quality Control质量控制UADR: Unexpected Adverse Drug Reaction,非预期药物不良反应-- 作者:月萝兰魂-- 发布时间:2006-12-22 13:34:00--GMP英语PIC/S的全称为harmaceutical Inspection Convention/Pharmaceutical Inspection Cooperation Scheme, PIC/S(制药检查草案), 药品检查协会(PIC/S) ,也有人称PIC/S为医药审查会议/合作计划(PIC/S)PIC的权威翻译:药品生产检查相互承认公约API(Active Pharmaceutical Ingrediet) 原料药又称:活性药物组分AirLock 气闸Authorized Person 授权人Batch/Lot 批次Batch Number/Lot-Number 批号;Batch Numbering System 批次编码系统;Batch Records 批记录;Bulk Product 待包装品;Calibration 校正;Clean area洁净区;Consignmecnt(Delivery)托销药品.ABPI Association of the British Pharmaceutical IndustryADR Adverse Drug ReactionAE Adverse EventAIM Active Ingredient ManufacturerANDA Abbreviated New Drug ApplicationANOVA Analysis of VarianceASM: Active Substance ManufacturerATC Anatomical Therapeutic ChemicalATX Animal Test Exemption CertificateBANBritish Approved NameBIRABritish Institute of Regulatory AffairsBNF British National FormularyBP British PharmacopoeiaC of A Certificate of AnalysisC of S Certificate of SuitabilityCENTRE FOR DRUG EVALUATION (CDE)Centre for Pharmaceutical Administration (CPA)CMS Concerned Member StateCMS每个成员国COS Certificate of SuitabilityCPMP Committee for Proprietary Medicinal ProductsCRA Clinical Research AssociateCRF Case Report FormCRO Contract Research OrganisationCTA Clinical Trial ApplicationCTC Clinical Trial CertificateCTD Common Technical DocumentCTX Clinical Trials ExemptionDDD Defined Daily DoseDGC Daily Global ComparisonDIA Drug Information AssociationDMF Drug Master FileDrug Registration Branch (DR, Product Evaluation & Registration Division, CPA EDQM (European Directorate for the Quality of Medicines) 欧洲联盟药品质量指导委员会EEA 欧洲经济地区EGMA European Generics Medicine AssociationELA Established Licence ApplicationEMEA European Medicines Evaluation AgencyEMEA (European Agency for the Evaluation of Medicinal Products) 欧洲联盟药品评价机构EP European PharmacopoeiaEPAR European Public Assessment ReportsESRA European Society of Regulatory AffairsEuropean Pharmacopoeia Commission 欧洲药典委员会FDA Food and Drug Administrationfinal evaluation report (FER)free sale certificates (FSCs)Health Sciences Authority (HSA)HSA's Medicines Advisory Committee (MAC)IB Investigators BrochureICH International Conference for HarmonisationIDMC Independent Data-Monitoring CommitteeIEC Independent Ethics CommitteeIND Investigational New DrugINN International Non-proprietary NameInternational Conference on Harmonisation (ICH)IPC In Process ControlIRB Institutional Review BoardLICENCE HOLDERMA Marketing AuthorisationMAA Marketing Authorisation ApplicationMAA上市申请MAH Marketing Authorisation HolderMAH 销售许可持有者MCA Medicines Control AgencyMHW Ministry of Health and Welfare (Japan)MR Mutual RecognitionMRA 美国与欧盟的互认协议MRAs (Mutual Recognition Agreements) 互相认证同意MRFG Mutual Recognition Facilitation Group MRPMutual Recognition ProcedureNASNew Active SubstanceNCENew Chemical EntityNDANew Drug Applicationnew chemical entities (NCEs)new drug applications (NDAs)NSAID Non Steroidal Anti Inflammatory DrugNTA Notice To ApplicantsOOS Out of SpecificationOTC Over The CounterPAGB Proprietary Association of Great BritainPh Eur European PharmacopoeiaPIL Patient Information LeafletPL Product LicencePOM Prescription Only MedicinePRODUCT OWNERPSU Periodic Safety UpdatesQA Quality AssuranceQC Quality ControlRAJ Regulatory Affairs JournalRMS Reference Member StateRMS相互认可另一成员国RSD Relative Standard DeviationRx Prescription OnlySAE Serious Adverse EventSMF Site Master FileSOP Standard Operating ProcedureSOP (STANDARD OPERATION PROCEDURE) 标准运作程序SPC/SmPC Summary of Product Characteristics summary of product characteristics(SPC)Therapeutic Goods Administration (TGA)USP US PharmacopoeiaVMF Veterinary Master FileVPC Veterinary Products CommitteeA.A.A Addition and Amendments 增补和修订AC Air Conditioner 空调器ADR Adverse Drug Reaction 药物不良反应AFDO Association of Food and Drug Officials 食品与药品官员协会(美国) ACC Accept 接受AQL Acceptable Quality Level 合格质量标准ADNA Abbreviated New Drug Application 简化的新药申请BOM Bill of Material 物料清单BPC Bulk pharmaceutical Chemiclls 原料药CBER Center for Biologics Evaluation Research 生物制品评价与研究中心CFU Colony Forming Unet 菌落形成单位DMF Drug Master File 药品管理档案CDER Cemter for Drug Evaluation amd Research 药物评价与研究中心CI Corporate Identity (Image) 企业识别(形象)CIP Cleaning in Place 在线清洗CSI Consumer Safety Insepctor 消费者安全调查员CLP Cleaning Line Procedure 在线清洗程序DAL Defect Action Level 缺陷作用水平DEA Drug Enforcement Adminestration 管制药品管理DS Documentation Systim 文件系统FDA Food and Drug Administration 食品与药品管理局(美国)GATT General Agreemernt on Tariffs and Trade 关贸总协会GMP Good Manufacturing Practice Gvp 药品生质量管理规范GCP Good Clinical Practice 药品临床实验管理规范GLP Good Laboratory Practice 实验室管理规范GSP Good Supply Practice 药品商业质量规范GRP Gook RaTAIL Practice 药品零业质量管理规范GAP Good Agriculture Practice 药材生产管理规范GVP Gook Validation Prctice 验证管理规范GUP Gook Use Practice 药品重用规范HVAC Heating Ventilation Air Conditioning 空调净化系统ISO Intematonal Organization for Standardization 车际标准化组织MOU Memorandum of Understanding 谅解备忘录PF Porduction File 生产记录用表格OTC Over the Counter (Drug) 非处方药品PLA Product License Application 产品许可申请QA Quality Assurance 质量保证QC Quality Control 质量控制QMP Quality Management Procedure 质量管理程序SDA State Drug Administration 国家药品监督管理局SMP Standard Managmert Procedure 标准管理程序SOP Standard Operating Procedure 标准操作程序TQC Tatal Quality Control 全面质量管理USA Uneted States Pharmacopeia 美国药典-- 作者:月萝兰魂-- 发布时间:2006-12-22 13:35:00--ICH 安全性领域常用专业术语中英文对照表Dead offspring at birth 出生时死亡的子代Degradation 降解 Delay of parturition 分娩延迟Deletion 缺失 Descriptive statistics 描述性统计 Distribution 分布Detection of bacterial mutagen 细菌诱变剂检测 Detection of clastogen 染色体断裂剂检测Determination of metabolites 测定代谢产物 Development of the offspring 子代发育Developmental toxicity 发育毒性 Diminution of the background lawn 背景减少Direct genetic damage 直接遗传损伤DNA adduct DNA加合物 DNA damage DNA损伤DNA repair DNA修复 DNA strand breaks DNA链断裂Dose escalation 剂量递增 Dose dependence 剂量依赖关系 Dose level 剂量水平Dose-limiting toxicity 剂量限制性毒性 Dose-raging studies 剂量范围研究Dose-relatived mutagenicity 剂量相关性诱变性 Dose-related 剂量相关Dose-relatived cytotoxicity 剂量相关性细胞毒性Dose-relatived genotoxic activity 剂量相关性遗传毒性Dose-response curve 剂量-反应曲线 Dosing route 给药途径Duration 周期 Duration of pregnancy 妊娠周期Eaning 断奶 Earlier physical malformation 早期躯体畸形Early embryonic development 早期胚胎发育Early embryonic development to implantation 着床早期的胚胎发育Electro ejaculation 电射精Elimination 清除Embryofetal deaths 胚胎和胎仔死亡 Embryo-fetal development 胚胎-胎仔发育Embryo-fetal toxicity 胚胎-胎仔毒性 Embryonic death 胚胎死亡Embryonic development 胚胎发育 Embryonic period 胚胎期Embryos 胚胎 Embryotoxicity 胚胎毒性Enantiomer 对映异构体End of pregnancy 怀孕终止 Endocytic 内吞噬(胞饮)Endocytic activity 内吞噬活性 Endogenous proteins 内源性蛋白Endogenous components 内源性物质 Endogenous gene 内源性基因Endonuclease 核酸内切酶 Emdpmiclease release from lysosomes 溶酶体释放核酸内切酶End-point 终点Epididymal sperm maturation 附睾精子成熟性 Epitope 抗原决定部位Error prone repair 易错性修复 Escalation 递增Escherichia coli strain 大肠杆菌菌株 Escherichia coli 大肠杆菌Evaluation of test result 试验结果评价Exaggerated pharmacological response 超常增强的药理作用Excretion 排泄(清除) Exposure assessment 接触剂量评价Exposure period 接解期 External metabolizing system 体外代谢系统F1-animals 子一代动物False positive result 假阳性结果Fecundity 多产 Feed-back 反馈 Fertilisation 受精 Fertility 生育力Fertility studies 生育力研究 Fetal abnormalities 胎仔异常Fetal and neonatal parameters 胎仔和仔鼠的生长发育参数Fetal development and growth 肿仔发育和生长 Fetal period 胎仔期 Fetotoxicity 胎仔毒性False negative result 假阴性结果First pass testing 一期试验Fluorescence in situ hybridization(FISH) 原位荧光分子杂交-- 作者:月萝兰魂-- 发布时间:2006-12-22 13:35:00--average deviation 平均差Bbar chart 直条图,条图bias 偏性binomial distribution 二项分布biometrics 生物统计学bivariate normal population 双变量正态总体Ccartogram 统计图case fatality rate(or case mortality) 病死率census 普查chi-sguare(X2) test 卡方检验central tendency 集中趋势class interval 组距classification 分组,分类cluster sampling 整群抽样coefficient of correlation 相关系数coefficient of regression 回归系数coefficient of variability(or coefficieut of variation) 变异系数collection of data 收集资料column 列(栏)combinative table 组合表combined standard deviation 合并标准差combined variance(or poolled variance) 合并方差complete survey 全面调查completely correlation 完全相关completely random design 完全随机设计confidence level 可信水平,置信水平confidence limit 可信限,置信限constituent ratio 构成比,结构相对数continuity 连续性control 对照control group 对照组coordinate 坐标correction for continuity 连续性校正correction for grouping 归组校正correction number 校正数correction value 校正值correlation 相关,联系correlation analysis 相关分析correlation coefficient 相关系数critical value 临界值cumulative frequency 累积频率Ddata 资料degree of dispersion 离散程度degree of freedom 自由度degree of variation 变异度dependent variable 应变量design of experiment 实验设计deviation from the mean 离均差diagnose accordance rate 诊断符合率difference with significance 差别不显著difference with significance 差别显著discrete variable 离散变量dispersion tendency 离中趋势distribution 分布,分配-- 作者:月萝兰魂-- 发布时间:2006-12-22 13:35:00--Eeffective rate 有效率eigenvalue 特征值enumeration data 计数资料equation of linear regression 线性回归方程error 误差error of replication 重复误差estimate value 估计值event 事件experiment design 实验设计experiment error 实验误差experimental group 实验组extreme value 极值Ffatality rate 病死率field survey 现场调查fourfold table 四格表freguency 频数freguency distribution 频数分布GGaussian curve 高斯曲线geometric mean 几何均数grouped data 分组资料Hhistogram 直方图homogeneity of variance 方差齐性homogeneity test of variances 方差齐性检验hypothesis test 假设检验hypothetical universe 假设总体Iincidence rate 发病率incomplete survey 非全面调检indepindent variable 自变量indivedual difference 个体差异infection rate 感染率inferior limit 下限initial data 原始数据inspection of data 检查资料intercept 截距interpolation method 内插法interval estimation 区间估计inverse correlation 负相关Kkurtosis coefficient 峰度系数Llatin sguare design 拉丁方设计least significant difference 最小显著差数least square method 最小平方法,最小乘法leptokurtic distribution 尖峭态分布leptokurtosis 峰态,峭度linear chart 线图linear correlation 直线相关linear regression 直线回归linear regression eguation 直线回归方程link relative 环比logarithmic normal distribution 对数正态分布logarithmic scale 对数尺度lognormal distribution 对数正态分布lower limit 下限Mmatched pair design 配对设计mathematical statistics 数理统计(学) maximum value 极大值mean 均值mean of population 总体均数mean square 均方mean variance 均方,方差measurement data 讲量资料median 中位数medical statistics 医学统计学mesokurtosis 正态峰method of least squares 最小平方法,最小乘法method of grouping 分组法method of percentiles 百分位数法mid-value of class 组中值minimum value 极小值mode 众数moment 动差,矩morbidity 患病率mortality 死亡率Nnatality 出生率natural logarithm 自然对数negative correlation 负相关negative skewness 负偏志no correlation 无相关non-linear correlation 非线性相关non-parametric statistics 非参数统计normal curve 正态曲线normal deviate 正态离差normal distribution 正态分布normal population 正态总体normal probability curve 正态概率曲线normal range 正常范围normal value 正常值normal kurtosis 正态峰normality test 正态性检验nosometry 患病率-- 作者:月萝兰魂-- 发布时间:2006-12-22 13:35:00--Oobserved unit 观察单位observed value 观察值one-sided test 单测检验one-tailed test 单尾检验order statistic 顺序统计量ordinal number 秩号ordinate 纵坐标Ppairing data 配对资料parameter 参数percent 百分率percentage 百分数,百分率percentage bar chart 百分条图percentile 百分位数pie diagram 园图placebo 安慰剂planning of survey 调查计划point estimation 点估计population 总体,人口population mean 总体均数population rate 总体率population variance 总体方差positive correlation 正相关positive skewness 正偏态prevalence rate 患病率probability 概率,机率probability error 偶然误差proportion 比,比率prospective study 前瞻研究prospective survey 前瞻调查public health statistics 卫生统计学Qquality eontrol 质量控制quartile 四分位数Rrandom 随机random digits 随机数字random numbers table 随机数目表random sample 随机样本random sampling 随机抽样random variable 随机变量randomization 随机化randomized blocks 随机区组,随机单位组randomized blocks analysis of variance 随机单位组方差分析randomized blocks design 随机单位组设计randomness 随机性range 极差,全距range of normal values 正常值范围rank 秩,秩次,等级rank correlation 等级相关rank correlation coefficent 等级相关系数rank-sum test 秩和检验ranked data 等级资料rate 率ratio 比recovery rate 治愈率registration 登记regression 回归regression analysis 回归分析regression coefficient 回归系数regression eguation 回归方程relative number 相对数relative ratio 比较相对数relative ratio with fixed base 定基比remainder error 剩余误差replication 重复retrospective survey 回顾调查Ridit analysis 参照单位分析Ridit value 参照单位值Ssample 样本sample average 样本均数sample size 样本含量sampling 抽样sampling error 抽样误差sampling statistics 样本统计量sampling survay 抽样调查scaller diagram 散点图schedule of survey 调查表semi-logarithmic chart 半对数线图semi-measursement data 半计量资料semi-guartile range 四分位数间距sensitivity 灵敏度sex ratio 性比例sign test 符号检验significance 显著性,意义significance level 显著性水平significance test 显著性检验significant difference 差别显著simple random sampling 单纯随机抽样simple table 简单表size of sample 样本含量skewness 偏态slope 斜率sorting data 整理资料sorting table 整理表sources of variation 变异来源square deviation 方差standard deviation(SD) 标准差standard error (SE) 标准误standard error of estimate 标准估计误差standard error of the mean 均数的标准误standardization 标准化standardized rate 标化率standardized normal distribution 标准正态分布statistic 统计量statistics 统计学statistical induction 统计图statistical inference 统计归纳statistical map 统计推断statistical method 统计地图statistical survey 统计方法statistical table 统计调查statistical test 统计表statistical treatment 统计检验stratified sampling 统计处理stochastic variable 分层抽样sum of cross products of 随机变量deviation from mean 离均差积和sum of ranks 秩和sum of sguares of deviation from mean 离均差平方和superior limit 上限survival rate 生存率symmetry 对称(性)systematic error 系统误差systematic sampling 机械抽样-- 作者:月萝兰魂-- 发布时间:2006-12-22 13:35:00--Tt-distribution t分布t-test t检验tabulation method 划记法test of normality 正态性检验test of one-sided 单侧检验test of one-tailed 单尾检验test of significance 显著性检验test of two-sided 双侧检验test of two-tailed 双尾检验theoretical frequency 理论频数theoretical number 理论数treatment 处理treatment factor 处理因素treatment of date 数据处理two-factor analysis of variance 双因素方差分析two-sided test 双侧检验two-tailed test 双尾检验type I error 第一类误差type II error 第二类误差typical survey 典型调查Uu test u检验universe 总体,全域ungrouped data 未分组资料upper limit 上限Vvariable 变量variance 方差,均方variance analysis 方差分析variance ratio 方差比variate 变量variation coefficient 变异系数velocity of development 发展速度velocity of increase 增长速度Wweight 权数weighted mean 加权均数Zzero correlation 零相关-- 作者:月萝兰魂-- 发布时间:2006-12-22 13:36:00--世界500强制药企业名称中英对照排名公司名称中文名称总部收入百万美元77 Pfizer 辉瑞美国 45950.092 Johnson & Johnson 强生美国 41862.0114 GlaxoSmithKline 葛兰素史克英国 35050.9193 Novartis 诺华瑞士 24864.0205 Roche Group 罗氏瑞士 23212.9222 Merck 默克美国 22485.9239 Bristol-Myers Squibb 百时美施贵宝美国 20894.0 248 Aventis 安万特法国 20162.4254 Abbott Laboratories 雅培美国 19680.6269 AstraZeneca 阿斯利康英国 18849.0330 Wyeth 惠氏美国 15850.6433 Eli Lilly 礼来大药厂美国 12582.5100 BASF 巴斯夫德国 37757.0125 Dow Chemical 道化学美国 32632.0129 Bayer 拜耳德国 32331.1365 Akzo Nobel 阿克苏诺贝尔荷兰 14770.7。
临床试验常用中英文词汇
SFDA Glossary：GCP，GLP，TRIAL Accuracy 准确度Active control，AC 阳性对照，活性对照Adverse drug reaction，ADR 药物不良反应Adverse event，AE 不良事件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 分段Block 层Block size 每段的长度BUN 尿素氮Carryover effect 延滞效应Case history 病历Case report form 病例报告表Case report form/ case record form，CRF 病例报告表，病例记录表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Clinical trial application，CTA 临床试验申请Clinical trial exemption，CTX 临床试验免责Clinical trial protocol，CTP 临床试验方案Clinical trial/ study report 临床试验报告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 interval 可信区间Confidence level 置信水平Consistency test 一致性检验Contract research organization，CRO 合同研究组织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 偏差Documentation 记录／文件Dose-reaction relation 剂量－反应关系Double blinding 双盲Double dummy 双模拟Double dummy technique 双盲双模拟技术Double-blinding 双盲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/ measurement 终点指标Equivalence 等效性Essential documentation 必须文件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GC－FTIR 气相色谱－傅利叶红外联用GC－MS 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Good clinical practice，GCP 药物临床试验质量管理规范Good manufacture practice，GMP 药品生产质量管理规范Good non-clinical laboratory practice，GLP 药物非临床研究质量管理规范Group sequential 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Improvement 好转Inclusion criteria 入选标准Independent ethics committee，IEC 独立伦理委员会Information consent form，ICF 知情同意书Information gathering 信息收集Informed consent，IC 知情同意Initial meeting 启动会议Inspection 视察／检查Institution inspection 机构检查Institution review board，IBR 机构审查委员会Intention to treat 意向治疗（——临床领域）Intention-to –treat，ITT 意向性分析（－统计学）Interactive voice response system，IVRS 互动式语音应答系统Interim analysis 期中分析Investigator 研究者Investigator's brochure，IB 研究者手册IR 红外吸收光谱Ka 吸收速率常Last observation carry forward，LOCF 最接近一次观察的结转LC－MS 液相色谱－质谱联用LD50 板数致死剂量Logic check 逻辑检查LOQ （Limit of Quantitation）定量限LOCF，Last observation carry forward 最近一次观察的结转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 监查员Monitoring 监查Monitoring report 监查报告MRT 平均滞留时间MS 质谱MS－MS 质谱－质谱联用MTD（Maximum Tolerated Dose）最大耐受剂量Multicenter trial 多中心试验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-blinding 非盲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 variable 主要变量Principal investigator 主要研究者Principle investigator，PI 主要研究者Product license，PL 产品许可证Protocol 试验方案Protocol 试验方案Protocol amendment 方案补正Quality assurance unit，QAU 质量保证部门Quality assurance，QA 质量保证Quality control，QC 质量控制Query list，query form 应用疑问表Randomization 随机化Randomization 随机Range check 范围检查Rating scale 量表Regulatory authorities，RA 监督管理部门Replication 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 样本含量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Significant level 检验水准Simple randomization 简单随机Single blinding 单盲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 verification，SDV 原始数据核准Source data，SD 原始数据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Statistical analysis plan 统计参数计划书Statistical analysis plan，SAP 统计分析计划Statistical model 统计模型Statistical tables 统计分析表Stratified 分层Study audit 研究稽查Subgroup 亚组Sub-investigator 助理研究者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 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T1/2 消除半衰期Target variable 目标变量T－BIL 总胆红素T－CHO 总胆固醇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 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Unblinding 揭盲Unblinding 破盲Unexpected adverse event，UAE 预料外不良事件UV－VIS 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 清洗期Washout period 洗脱期Well-being 福利，健康。
- 1、下载文档前请自行甄别文档内容的完整性，平台不提供额外的编辑、内容补充、找答案等附加服务。
- 2、"仅部分预览"的文档,不可在线预览部分如存在完整性等问题,可反馈申请退款(可完整预览的文档不适用该条件!)。
- 3、如文档侵犯您的权益，请联系客服反馈,我们会尽快为您处理(人工客服工作时间：9:00-18:30)。
临床试验常用的英文Accuracy 准确度Active control, AC 阳性对照，活性对照Adverse drug reaction, ADR 药物不良反应Adverse event, AE 不良事件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Blinding method 盲法Blinding/ masking 盲法，设盲Block 分段Block size 每段的长度BUN 尿素氮Carryover effect 延滞效应Case history 病历Case report form/ case record form, CRF 病例报告表，病例记录表Categorical variable 分类变量Cav 平均浓度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Clinical trial application, CTA 临床试验申请Clinical trial exemption, CTX 临床试验免责Clinical trial protocol, CTP 临床试验方案Clinical trial/ study report 临床试验报告C max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 interval 可信区间Confidence level 置信水平Consistency test 一致性检验Contract research organization, CRO 合同研究组织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 偏差Documentation 记录／文件Dose-reaction relation 剂量－反应关系Double blinding 双盲Double dummy 双模拟Double dummy technique 双盲双模拟技术Double-blinding 双盲Drop out 脱落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/ measurement 终点指标Equivalence 等效性Essential documentation 必须文件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GC－FTIR 气相色谱－傅利叶红外联用GC－MS 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Good clinical practice, GCP 药物临床试验质量管理规范Good manufacture practice, GMP 药品生产质量管理规范Good non-clinical laboratory practice, GLP 药物非临床研究质量管理规范Group sequential design 成组序贯设计Hypothesis test 假设检验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Improvement 好转Inclusion criteria 入选标准Independent ethics committee, IEC 独立伦理委员会Information consent form, ICF 知情同意书Information gathering 信息收集Informed consent, IC 知情同意Initial meeting 启动会议Inspection 视察／检查Institution inspection 机构检查Institution review board, IBR 机构审查委员会Intention to treat 意向治疗（-- 临床领域）Intention-to –treat, ITT 意向性分析(－统计学）Interim analysis 期中分析Investigator 研究者Investigator’s brochure, IB研究者手册IR 红外吸收光谱Ka 吸收速率常Last observation carry forward, LOCF 最接近一次观察的结转LC－MS 液相色谱－质谱联用LD50半数致死剂量Logic check 逻辑检查LOQ (Limit of Quantitation) 定量限LOCF, Last observation carry forward 最近一次观察的结转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 监查员Monitoring 监查Monitoring report 监查报告MRT 平均滞留时间MTD（Maximum Tolerated Dose）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-blinding 非盲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 variable 主要变量Principal investigator 主要研究者Principle investigator, PI 主要研究者Product license, PL 产品许可证Protocol 试验方案Protocol amendment 方案补正Quality assurance unit, QAU 质量保证部门Quality assurance, QA 质量保证Quality control, QC 质量控制Query list, query form 应用疑问表Randomization 随机化Range check 范围检查Rating scale 量表Regulatory authorities, RA 监督管理部门Replication 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Significant level 检验水准Simple randomization 简单随机Single-blinding 单盲Site audit 试验机构稽查Source data verification, SDV 原始数据核准Source data, SD 原始数据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, SAP 统计分析计划Statistical model 统计模型Statistical tables 统计分析表Stratified 分层Study audit 研究稽查Subgroup 亚组Sub-investigator 助理研究者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 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T1/2消除半衰期Target variable 目标变量T－BIL 总胆红素T－CHO 总胆固醇TG 热重分析TLC、HPLC 制备色谱T max峰时间TP 总蛋白Transformation 变量变换Treatment group 试验组Trial error 试验误差Trial 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Unblinding 揭盲Unexpected adverse event, UAE 预料外不良事件UV－VIS 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 period 洗脱期Well-being 福利，健康。