临床试验中英对照词汇表english vocabulary of clinical trials-yrn2019051011

临床试验中英对照词汇表english vocabulary of clinical trials-yrn2019051011
临床试验中英对照词汇表english vocabulary of clinical trials-yrn2019051011

(完整版)英语语法专业术语

英语语法专业术语 语法grammar 句法syntax 词法morphology 结构structure 层次rank 句子sentence 从句clause 词组phrase 词类part of speech 单词word 实词notional word 虚词structural word 名词noun 专有名词proper noun 普通名词common noun 可数名词countable noun 不可数名词uncountable no 抽象名词abstract noun 具体名词concrete noun 物质名词material noun 集体名词collective noun 个体名词individual noun 介词preposition 连词conjunction 动词verb 主动词main verb 及物动词transitive verb 不及物动词intransitive verb 系动词link verb 助动词auxiliary verb 情态动词modal verb 规则动词regular verb 不规则动词irregular verb 短语动词phrasal verb 限定动词finite verb 非限定动词infinite verb 使役动词causative verb 感官动词verb of senses

动态动词event verb 静态动词state verb 感叹词exclamation 形容词adjective 副词adverb 方式副词adverb of manner 程度副词adverb of degree 时间副词adverb of time 地点副词adverb of place 修饰性副词adjunct 连接性副词conjunct 疑问副词interrogative adverb 关系副词relative adverb 代词pronoun 人称代词personal pronoun 物主代词possessive pronoun 反身代词reflexive pronoun 相互代词reciprocal pronoun 指示代词demonstrative pronoun 疑问代词interrogative pronoun 关系代词relative pronoun 不定代词indefinite 物主代词possessive pronoun 名词性物主代词nominal possessive 形容词性物主代词adjectival possessive pronoun 冠词article 定冠词definite article 不定冠词indefinite article 数词numeral 基数词cardinal numeral 序数词ordinal numeral 分数词fractional numeral 形式form 单数形式singular form 复数形式plural form 限定动词finite verb form 非限定动词non-finite verb form

英语语法专业术语表达

英语语法专业术语表达 英语语法语语语语表达 1. Morphology 语法 2,Notional Words 语语语3, Form Words 虚语 4,Parts of Speech 语语 5,The Noun 名语 6,The Pronoun 代语 7,The Numeral 数语 8,The Verb 语语 9,The Adjective 形容语 10. The Adverb 副语 11. The Article 冠语 12. The Preposition 介语 13. The conjunction 语语 14. The Interjection 感语语15. The Particle 小品语 16. Word Building 构语法17. Conversion 语化 18. Derivation 派生 19. Composition 合成 20. Prefix 前语 21. Suffix 后语 22. Compound Words 合成语23. Classification of Nouns 名语的分语

24. Common Nouns 普通名语 25. Proper Nouns 语有名语26. Countable Nouns 可名语数27. Uncountable Nouns 不可名语数28. The Singular Form 语形式数29. The Plural Form 语形式数 30. Individual Nouns个体名语31. Collective Nouns集名语体32. Material Nouns物语名语33. Abstract Nouns抽象名语34. The Common Case普通格35. The Possessive Case所有格36, Personal Pronouns 人代语称37. Possessive Pronouns物主代语38. Self Pronouns反身代语39. Demonstrative Pronouns指示代语40. Interrogative Pronouns疑语代语不意达41. Conjunctive Pronouns语接代语42. Relative Pronouns语系代语43. Indefinite Pronouns不定代语44. Reciprocal Pronouns相互代语45. The Subjective Case主格46. The Objective Case语格47. Cardinal Numerals基语数48. Ordinal Numerals 序语数49. Fractional Numerals分语数50,Notional Verbs语意语语 51. Link Verbs语系语语 52. Auxiliary Verbs助语语 53. Modal Verbs情语语语 54. Transitive Verbs及物语语 55. Intransitive Verbs不及物语语56. Regular Verbs语语语语 57. Irregular Verbs不语语语语 58. Person人称 59. Number数 60. Tense语语 61. Voice语语 62. Mood语气

FDA-NDA新药Ⅰ期临床试验申报资料(英语原文)

Guidance for Industry Content and Format of Investigational New Drug Applications (INDs) for Phase 1 Studies of Drugs, Including Well-Characterized, Therapeutic, Biotechnology-derived Products Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) November 1995 CLIN 2

TABLE OF CONTENTS I.INTRODUCTION (1) II.CURRENT REQUIREMENTS AND PRACTICES (2) III.CLARIFICATIONS OF PRESENT IND REGULATIONS (2) A.Cover Sheet (3) B.Table of Contents (3) C.Introductory Statement and General Investigational Plan (3) D.Investigator's Brochure (3) E.Protocols (3) F.Chemistry, Manufacturing, and Control Information (4) G.Pharmacology and Toxicology Information (10) H.Previous Human Experience with the Investigational Drug (14) I.21 CFR 312.23(a)(10), (11) and (b), (c), (d), and (e) (14) IV.REFERENCES (14) i

临床试验英语词汇(2018年)

临床试验常用英语词汇大全 基础词汇 Clinical Trial 临床试验 Protocol 试验方案 Synopsis 摘要 Study Objective 研究目的 Study Endpoint 研究终点 Study Design 研究设计 Study Procedure 研究流程 Study Completion 研究完成 Study Termination 研究终止 Baseline 基线 Inclusion Criteria 入组标准 Exclusion Criteria 排除标准 IVRS- Interactive Voice Response System 交互式语音应答系统IWRS- Interactive Web Response System 交互式网络应答系统SDV -Source Data Verification 原始数据核查 EDC- Electronic Data Capture 电子数据采集 Statistical Methods 统计学方法 Single Blinding 单盲 Double Blinding 双盲 Placebo 安慰剂

Placebo Control 安慰剂对照 Active Control 阳性对照、活性对照 Blank Control 空白对照 Blinding/Masking 盲法/设盲 Randomized, Double-blind Study 随机对照双盲试验Outcome Assessment 结果评价 Multi-center Trial 多中心试验 OS-Overall Survival 总生存期 PFS- Progression Free Survival 无进展生存期 Contract/Agreement 合同/协议 GCP- Good Clinical Practice 药物临床试验质量管理规范GMP- Good Manufacturing Practice 药品生产质量管理规范SOP- Standard Operating Procedure 标准操作规程Protocol Amendments 修正案 CRF- Case Report Form 病历报告表 IB- Investigator’s Brochure 研究者手册 ICF- Informed Consent Form 知情同意书 QA- Quality Assurance 质量保证 QC-Quality Control 质量控制 Monitoring 监查 Monitor 监查员 Audit 稽查 Auditor 稽查员

教师资格证英语语法专业术语

语法grammar 句法syntax 结构structure 句子sentence 从句clause 词组phrase 词类part of speech 单词word 实词notional word 虚词structural word 单纯词simple word 派生词derivative 复合词compound 词性part of speech 名词noun 专有名词proper noun 普通名词common noun 可数名词countable noun 不可数名词uncountable noun 抽象名词abstract noun 具体名词concret noun 物质名词material noun 集体名词collective noun 个体名词individual noun 介词preposition 连词conjunction 动词verb 及物动词transitive verb 不及物动词intransitive verb 系动词link verb 助动词auxiliary verb 情态动词modal verb 规则动词regular verb 不规则动词irregular verb 限定动词finite verb 非限定动词infinite verb 使役动词causative verb 感官动词verb of senses 感叹词exclamation 形容词adjective 副词adverb 方式副词adverb of manner 程度副词adverb of degree 时间副词adverb of time 地点副词adverb of place 关系副词relative adverb 代词pronoun 人称代词personal pronoun 物主代词possessive pronoun 反身代词reflexive pronoun 指示代词demonstrative pronoun 疑问代词interrogative pronoun 关系代词relative pronoun 不定代词indefinite pronoun 物主代词possessive pronoun 名词性物主代词nominal possessive pronoun 形容词性物主代词adjectival possessive pronoun 冠词article 定冠词definite article 不定冠词indefinite article 形式form 单数形式singular form 复数形式plural form 原形base form 从句clause 从属句subordinate clause 并列句coordinate clause 名词从句nominal clause 定语从句attributive clause 状语从句adverbial clause 宾语从句object clause 主语从句subject clause 同位语从句appositive clause 时间状语从句adverbial clause of time 地点状语从句adverbial clause of place 方式状语从句adverbial clause of manner 让步状语从句adverbial clause of concession 原因状语从句adverbial clause of cause 结果状语从句adverbial clause of result 目的状语从句adverbial clause of purpose 条件状语从句adverbial clause of condition 句子sentence 简单句simple sentence 并列句compound sentence 复合句complex sentence 并列复合句compound complex sentence 陈述句declarative sentence

临床试验常用的英文缩写

专业术语 缩略语英文全称中文全称 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 BMI Body Mass Index 体质指数 CI Co-investigator 合作研究者 COI Coordinating Investigator 协调研究者 CRA Clinical Research Associate 临床监查员(临床监察员)CRC Clinical Research Coordinator 临床研究协调者 CRF Case Report Form 病历报告表 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 CTX Clinical Trial Exemption 临床试验免责 CTP Clinical Trial Protocol 临床试验方案 CTR Clinical Trial Report 临床试验报告 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 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GLP Good Laboratory Practice 药物非临床试验质量管理规范GMP Good Manufacturing Practice 药品生产质量管理规范 IB Investigator’s Brochure研究者手册 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

英语语法专业术语表达

active voice 主动语态,passive voice被动语态, absolute construction独立结构, adjective 形容词,adverd 副词,noun名词, verb动词, artical冠词, determiner限定词,quantifier量词,numeral数词, subject主语, object宾语,adverbial状语,attributive定语,complement补语,predicative表语,appositive同位语,infinitive不定式, -ing participle-ing分词, -Ed participle -ed分词,finite clause 限定从属分句,non-finitive clause非限定分句,inversion倒装,adverbial clause状语从句,subject clause主语从句,relative clause/attributive clause定语(关系)从句,从句也可以用clause as subject/object/来表示主语从句、宾语从句 时态:tense语态:voice单数:singular form复数:plural form 主谓一致:agreement of subject and verb 定语从句:attributive clause 名词性从句: noun clause 状语从句:adverbial clause 虚拟语气:subjunctive mood 冠词:article代词:pronoun形容词和副词:adjective & adverb 动词和动词词组:verbs & verb phrase 非谓语动词:Non-Predicate Verbs / Non-Finite verbs

药物临床试验常用英文

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 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

完整word版,临床试验常见英文缩写

临床试验常见英文缩写 ADR(Adverse drug reaction)不良反应 AE(Adverse event)不良事件 SAE(Serious Adverse Event)严重不良事件 CRF(Case report form/case record form)病例报告表 CRO(Contract research organization)合同研究组织 EC(Ethics Committee)伦理委员会 GCP(Good clinical practice)药品临床试验管理规范 EDC(Electronic data capture)电子数据采集 IB(Investigator's Brochure)研究者手册 ND (Not Done) 未做 NA (Not Applicable) 不适用 UK (Unknown) 未知 PI(Principal investigator )主要研究者 Sub-I(Sub-investigator) 助理研究者 QA(Quality assurance) 质量保证 QC(Quality control) 质量控制 SDV(Source data verification)原始资料核对 SD(Source data)原始数据 SD(Source document ) 原始文件 SFDA 国家食品药品监督管理局 SOP(Standard operating procedure) 标准操作规程 IRB 机构审查委员会 ICF(Informed Consent Form) 知情同意书 TMF(trial master file)研究管理文件夹 临床试验常见英文单词 A ?Active control ,AC 阳性对照,活性对照阳性对照,活性对照?Adverse drug reaction ,ADR 药物不良反应药物不良反应?Adverse event ,AE 不良事件 ?Approval 批准 ?Assistant investigator 助理研究者 ?Audit 稽查 ?Audit report 稽查报告 ?Auditor 稽查员 B ?Bias 偏性,偏倚 ?Blank control 空白对照 ?Blinding/masking 盲法,设盲 ?Block 层 C ?Case history 病历 ?Case report form/case record form ,CRF 病例报告表,病例记录表?Clinical study 临床研究

医药行业专业英语词汇(非常有用)

FDA 和EDQM 术语: CLINICAL TRIAL :临床试验 ANIMAL TRIAL :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 BENIFIT (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 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、):国际非专有名称NF ).

USP(THE UNITED STATES PHARMACOPEIA ):美国药典 NF (NATIONAL FORMULARY ):(美国)国家处方集 OFFICIAL = PHARMACOPEIAL= COMPENDIAL :药典的;法定的;官方的 AGENCY :审理部门(指FDA ) 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 REGULATORY METHODS VALIDATION :管理用分析方法的验证 COS/CEP 欧洲药典符合性认证 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 ICH 文件分为质量、安全性、有效性和综合学科 4 类。 质量技术要求文件以Q 开头,再以a,b,c,d 代表小项: Q1:药品的稳定性 Q2: 方法学 Q3: 杂质 Q4: 药典 Q5: 生物技术产品质量 Q6: 标准规格 Q7:GMP

英语语法常用词汇

English grammar terms often used 英语语法常用词语1.Parts of speech 词类 noun 名词pronoun 代词numeral 数词adjective 形容词verb 动词adverb副词article 冠词preposition介词conjunction连词interjection感叹词particle 小品词 2. Word building 构词法 conversion 转化derivation 派生affixation词缀法prefix前缀suffix后缀compound words 合成词 3.Classification of nouns 名词的分类 common nouns普通名词proper nouns 专有名词 individual nouns个体名词collective nouns 集合名词 material nouns 物质名词abstract nouns 抽象名词 countable nouns 可数名词uncountable nouns不可数名词 the singular form 单数形式the plural form 复数形式 the common case 普通格the possessive case 所有格 the subjective case 主格the objective case 宾格 person 人称third person singular 第三人称单数 4. Classification of pronouns 代词的分类 personal pronouns 人称代词possessive pronouns 物主代词 self pronouns 反身代词demonstrative pronouns 指示代词 interrogative pronouns 疑问代词conjunctive pronouns 连接代词 relative pronouns 关系代词reciprocal pronouns 相互代词 indefinite pronouns 不定代词 5.数词、形容词、冠词 cardinal numerals 基数词ordinal numerals 序数词 fractional numerals 分数词the comparative degree 比较级 the superlative degree 最高级The definite article 定冠词 the indefinite article 不定冠词 6.Classification of verbs 动词的分类 national verbs 实义动词link-verbs系动词 auxiliary verbs助动词modal verbs 情态动词 transitive verbs 及物动词intransitive verbs 不及物动词 regular verbs 规则动词irregular verbs 不规则动词 the present forms 现在式the past forms 过去式 the participle 分词the present participle现在分词 the past participle 过去分词the infinitive 不定式 the gerund 动名词bare infinitive 不带to的不定式

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

常见英语语法速记

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