染雾临床试验常见英语词汇 篇一
Clinical Trial Common English Vocabulary
Clinical trials are an essential part of medical research and development. They help researchers evaluate the effectiveness and safety of new treatments and interventions. To better understand and communicate about clinical trials, it is important to be familiar with the common English vocabulary used in this field. In this article, we will introduce some of the frequently used terms in clinical trials.
1. Informed Consent: This refers to the process of providing potential participants with all the necessary information about the trial, including its purpose, procedures, risks, and benefits, so that they can make an informed decision about whether to participate.
2. Randomization: Randomization is the process of assigning participants to different treatment groups randomly. This is done to ensure that the groups are comparable and that any differences observed between the groups are due to the treatment being studied rather than other factors.
3. Placebo: A placebo is an inactive substance or treatment given to some participants in a clinical trial. It is used as a control to compare the effects of the experimental treatment. Placebos are often used in double-blind trials, where neither the participants nor the researchers know who is receiving the experimental treatment and who is receiving the placebo.
4. Blinding: Blinding refers to the process of concealing information about the assigned treatment from participants, researchers, or both. It helps to minimize bias and ensure that the results of the trial are not influenced by the expectations of the participants or researchers.
5. Adverse Event: An adverse event is any undesirable occurrence that happens to a participant during a clinical trial, whether or not it is related to the treatment being studied. Adverse events can range from mild side effects to serious complications and are carefully monitored and reported throughout the trial.
6. Protocol: A protocol is a detailed plan or set of guidelines that outlines the objectives, design, methodology, and statistical analysis of a clinical trial. It provides a framework for conducting the trial and ensures that it is carried out in a standardized and ethical manner.
7. Endpoint: An endpoint is a specific outcome or event that is measured to determine the effectiveness of a treatment. Common endpoints in clinical trials include survival rates, disease progression, symptom improvement, or adverse events.
8. Data Monitoring Committee (DMC): A DMC is an independent group of experts who oversee the progress and safety of a clinical trial. They review and analyze the interim data at regular intervals to ensure the ongoing safety of the participants and to make recommendations regarding the continuation, modification, or termination of the trial.
9. Inclusion and Exclusion Criteria: Inclusion criteria are the specific characteristics or conditions that a participant must meet to be eligible for a clinical trial. Exclusion criteria, on the other hand, are the characteristics or conditions that disqualify a person from participating in the trial. These criteria help researchers select participants who are most likely to benefit from the treatment and minimize the potential risks.
10. Investigational Product: An investigational product is the experimental treatment or intervention being studied in a clinical trial. It can be a new drug, device, diagnostic test, or therapeutic procedure that has not yet been approved by regulatory authorities for general use.
These are just a few of the many terms commonly used in the field of clinical trials. By familiarizing ourselves with these vocabulary words, we can better understand and discuss the important work being done in medical research and contribute to the advancement of healthcare.
临床试验常见英语词汇 篇二
Clinical Trial Common English Vocabulary
In the field of clinical trials, there are many technical terms and jargon that can be difficult to understand for those who are not familiar with the industry. In this article, we will introduce some commonly used English vocabulary in clinical trials to help improve comprehension and communication.
1. Protocol: A protocol is a detailed plan that outlines the objectives, design, methodology, and statistical analysis of a clinical trial. It serves as a roadmap for conducting the trial and ensures that it is carried out in a standardized and ethical manner.
2. Informed Consent: Informed consent is the process of providing potential participants with all the necessary information about the trial, including its purpose, procedures, risks, and benefits, so that they can make an informed decision about whether to participate.
3. Randomization: Randomization is the process of assigning participants to different treatment groups randomly. This is done to ensure that the groups are comparable and that any differences observed between the groups are due to the treatment being studied rather than other factors.
4. Placebo: A placebo is an inactive substance or treatment given to some participants in a clinical trial. It is used as a control to compare the effects of the experimental treatment. Placebos are often used in double-blind trials, where neither the participants nor the researchers know who is receiving the experimental treatment and who is receiving the placebo.
5. Blinding: Blinding refers to the process of concealing information about the assigned treatment from participants, researchers, or both. It helps to minimize bias and ensure that the results of the trial are not influenced by the expectations of the participants or researchers.
6. Adverse Event: An adverse event is any undesirable occurrence that happens to a participant during a clinical trial, whether or not it is related to the treatment being studied. Adverse events can range from mild side effects to serious complications and are carefully monitored and reported throughout the trial.
7. Endpoint: An endpoint is a specific outcome or event that is measured to determine the effectiveness of a treatment. Common endpoints in clinical trials include survival rates, disease progression, symptom improvement, or adverse events.
8. Data Monitoring Committee (DMC): A DMC is an independent group of experts who oversee the progress and safety of a clinical trial. They review and analyze the interim data at regular intervals to ensure the ongoing safety of the participants and to make recommendations regarding the continuation, modification, or termination of the trial.
9. Inclusion and Exclusion Criteria: Inclusion criteria are the specific characteristics or conditions that a participant must meet to be eligible for a clinical trial. Exclusion criteria, on the other hand, are the characteristics or conditions that disqualify a person from participating in the trial. These criteria help researchers select participants who are most likely to benefit from the treatment and minimize the potential risks.
10. Investigational Product: An investigational product is the experimental treatment or intervention being studied in a clinical trial. It can be a new drug, device, diagnostic test, or therapeutic procedure that has not yet been approved by regulatory authorities for general use.
By familiarizing ourselves with these commonly used terms, we can improve our understanding of clinical trials and actively participate in discussions about medical research and development. A better grasp of the vocabulary will contribute to the advancement of healthcare and the development of new and improved treatments.
临床试验常见英语词汇 篇三
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
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
临床试验常见英语词汇 篇四
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
临床试验常见英语词汇 篇五
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
临床试验常见英语词汇 篇六
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)
