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。
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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。