临床试验英语词汇(2018)

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- Investigators 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Inspection 视察CFDA - China Food and Drug Administration 国家食品药品监督管理局FDA- Food and Drug Administration 美国食品与药品监督管理局ICH- International Conference on Harmonization 国际协调会议IEC Independent Ethics Committee 独立伦理委员会IRB-Institutional Review Board 机构审查委员会Sponsor 申办者CRO -Contract Research Organization 合同研究组织SMO-Site Management Organization 现场管理组织Investigational Site 研究中心Investigator 研究者PI- Principal Investigator 主要研究者SI- Sub-investigator 助理研究者CRC- Clinical Research Coordinator 临床研究协调员Initial Meeting 启动会SIV-Site Initiation Visit 中心启动访视受试者相关Subject 受试者Subject Screening Log 受试者筛选表Subject Enrollment Log 受试者入选表Subject Identification Code 受试者识别代码FPI/FSI-First Patient/Subject In 首例受试者入组LPI/LSI-Last Patient/Subject In 末例受试者入组LPO/LSO-Last Patient/Subject Out 末例受试者出组Recruitment 招募Screening 筛选Randomization 随机Enrollment 入组Visit 访视Visit Window 访视窗口期Out of Visit Window 超窗Follow Up 随访Withdrawal 脱落Compliance 依从性Wash-out Period 洗脱期Cycle 周期Treatment Allocation 治疗分配Patient File 病人档案Case Record/Medical History 病历SD -Source Data/Document/Documentation 原始数据/文件Subject Diary 受试者日记Demography 人口统计学DOB-Date of Birth 出生日期Race 种族Physical Exam 体格检查Vital Signs 生命体征Height 身高Weigh 体重Temperature 体温Pulse/Heart rate 脉搏/心率Systolic Blood Pressure 收缩压Diastolic Blood Pressure 舒张压ECG-Electrocardiogram 心电图Chest X-ray 胸部X光Image 影像学实验室相关Laboratory Assessment 实验室评估CS/NCS-Clinical Significant/Non-Clinical Significant 有临床意义/无临床意义Hematology/Blood Routine Test 血液学/血常规Hemoglobin 血红蛋白Platelets 血小板RBC-Red Blood Cell 红细胞WBC-White Blood Cell 白细胞Neutrophils 中性粒细胞Lymphocytes 淋巴细胞Monocytes 单核细胞Eosinophils 嗜酸性粒细胞Basophils 嗜碱性粒细胞Urinalysis 尿液分析Glucose 葡萄糖Ketones 酮体Leukocytes 粒性白细胞Nitrite 亚硝酸盐Bilirubin 胆红素Protein 蛋白Crystals 晶体pH 酸碱度Blood Biochemistry 血液生化Calcium 钙Magnesium 镁Phosphorus 磷Sodium 钠Potassium 钾Chloride 氯Creatinine 肌酐BUN-Blood Urea Nitrogen 尿素氮TP- Total Protein 总蛋白Albumin 白蛋白AST /SGOT 谷草转氨酶/门冬氨酸氨基转移酶ALT/ SGPT 谷丙转氨酶/丙氨酸氨基转移酶ALP-Alkaline Phosphatase 碱性磷酸酶TB- Total Bilirubin 总胆红素LDH 乳酸脱氢酶GGT 谷氨酰转氨酶Glucose 葡萄糖Blood Coagulation 凝血PT-Prothrombin Time 凝血酶原时间PT-INR 凝血酶原时间-国际标准化比值APTT 活化部分凝血活酶时间药物相关IP-Investigational Product 研究产品CM -Concomitant Medication 合并用药Drug Receive 药物接收Drug Storage 药物储存Drug Dispense 药物分发Drug Return 药物返还Drug Destroy 药物销毁Quantity 数量Medication No. 研究药品编号Packaging 包装Labeling 标签Drug Accountability 药物清点Drug Administration 药物使用Overdose 药物过量Dose Reduce 剂量降低Dose Interrupt 剂量中断（暂停）Dose Discontinuation 剂量终止（完全终止）不良事件相关ADR- Adverse Drug Reaction 药物不良反应AE- Adverse Event 不良事件SAE Serious Adverse Event 严重不良事件Seriousness 严重性（性质）Severity 严重程度（程度）Grade 级别Results in death 导致死亡Life threatening 危急生命Requires or prolongs hospitalization 导致或延长住院时间Congenital anomaly/Birth defect 先天畸形/出生缺陷Persistent or significant disability/ incapacity 永久或重大伤残/丧失工作能力Mild 轻度Moderate 中度Severe 重度Safety Assessment/Evaluation 安全评估SUSAR=Serious and Unexpected Suspected Adverse Reaction 严重的非预期疑似相关的药品不良反应Anemia 贫血（血红蛋白降低）Hemoglobin increased 血红蛋白升高Hypertension 高血压Hypotension 低血压Abdominal pain 腹痛Stomach pain 胃痛Constipation 便秘Diarrhea 腹泻Nausea 恶心