Clinical Trial Regulations
ICH管委会成员国药物临床试验质量管理规范相关法规启示
CHINA MEDICINE AND PHARMACY Vol.10 No.24 December 20202512020年12月第10卷第24期·工作探讨·ICH管委会成员国药物临床试验质量管理规范相关法规启示苏 娴国家药品监督管理局药品审评中心临床试验管理处，北京 100022[摘要] 临床质量管理规范（GCP）是重要的国际协调会议（ICH）一级指导原则。
本文结合ICH 管委会成员国药物临床试验质量管理规范相关法规，概述了GCP 的相关法律框架，探讨了ICH-E6与GCP 的关系，并总结了欧盟、美国和日本的GCP 特色要求。
对于实施默示许可制的我国来说，借鉴欧美临床试验暂停和提前终止管理要求的先进相关经验，将在提高审评效率同时有效的控制风险。
为欧美日GCP 相较于ICH-GCP 特色的要求更细化、更强化的体现了GCP 对受试者的保护和数据可靠性的保证，同时又兼顾了本国的国情和相关法规的兼容性，是十分值得我国GCP 借鉴的，建议随着我国临床试验监管科学的不断发展，逐步推进完备的临床试验管理法律体系的建立。
[关键词]临床试验；临床质量管理规范（GCP）；国际协调理事会（ICH）；监管科学[中图分类号] R197 [文献标识码] A [文章编号] 2095-0616（2020）24-251-03ICH Administrative Committee member states drug clinical trialquality management standards related regulationsSU XianCentre for Drug Evaluation, National Medical Products Administration, Beijing 100022, China[Abstract] Good Clinical Practice (GCP) is an important guiding principle in International Council for Harmonization (ICH). This paper summarizes the relevant legal framework of GCP, discusses the relationship between ICH-E6 and GCP, and summarizes the characteristic requirements of GCP in the European Union, the United States and Japan based on the relevant regulations of the QUALITY management standards for drug clinical trials of member states of THE ICH Administrative Committee. For Our country implementing the implied licensing system, drawing on the advanced relevant experience of the European and American clinical trial suspension and early termination management requirements will improve the evaluation efficiency and effectively control the risk. For Europe and the United States, GCP compared with, for example-the characteristics of GCP requirements more refinement strengthening embodies the GCP the protection of the subjects and the guarantee of data reliability, at the same time, both the country's state of the compatibility and related laws and regulations, it is very worthy of GCP for reference in our country, suggested that with the continuous development of our country clinical trials regulatory science, gradually promote the establishment of a complete clinical trial management legal system.[Key words] Clinical trial; Good Clinical Practice; International Council for Harmonization; Regulatory science临床质量管理规范（Good Clinical Practice，GCP）是为保证临床试验数据的质量、保护受试者的安全和权益的临床试验全过程标准化、规范化管理的规定。
医疗器械监督管理条例-英文
RegulationsRegulations for the Supervision and Administration ofMedical DevicesRegulations for the Supervision and Administration of Medical DevicesChapter I General ProvisionsArticle 1 These Regulations are hereby formulated with a view to strengthening the supervision and administration of medical devices， ensuring their safety andeffectiveness and protecting human health and life safety。
Article 2 All units or individuals engaged in the research and development， production，distribution， use, supervision and administration of medical devices within the territory of the Peoples Republic of China shall comply with the Regulation.Article 3 ”Medical devices” as defined by these regulations refers to： any instrument，apparatus， appliance, material, or other article whether used alone or in combination, including the software necessary for its proper application。
临床试验术语解释
临床试验代表含义:指任何在人体（病人或健康志愿者）进行药物的系统性研究，以证实或揭示试验药物的作用、不良反应及/或试验药物的吸收、分布、代谢和排泄，目的是确定试验药物的疗效与安全性。
Ⅰ临床研究代表含义:首次在人体进行研究药物的周密试验计划，受试对象是少量（开放20~30例）正常成年健康自愿者。
目的是观察药物在人体内的作用机制。
Ⅱ临床研究代表含义:在只患有确立的适应症的病患者（盲法不小于100对）上进行的研究，目的是找出最佳的剂量范围和考虑治疗可行性Ⅲ临床研究代表含义:确定研究药物的有效性和安全性、受益和危害比率。
（试验组不小于300例。
）Ⅳ临床研究代表含义:新药获准注册上市后的大型研究，检察普遍临床使用时的不良反应和毒性。
药品临床试验管理规范代表含义:对临床试验的设计、实施和执行，监查、稽查、记录、分析和报告的标准。
该标准是数据和报告结果的可信和精确的保证；也是受试者权益、公正和隐私受保护的保证。
伦理委员会代表含义:是指一个由医学，科学专业人员及非医学，非科学人员共同组成的独立体，其职责是通过对试验方案、研究者资格、设备、以及获得并签署受试者知情同意书的方法和资料进行审阅、批准或提出建议来确认临床试验所涉及的人类受试者的权益、安全性和健康受到保护，并对此保护提供公众保证。
申办者代表含义:发起一项临床试验，并对该试验的启动、管理、财务和监查负责的公司、机构或组织。
研究者代表含义:实施临床试验并对临床试验的质量及受试者安全和权益的负责者。
研究者必须经过资格审查，具有临床试验的专业特长、资格和能力。
协调研究者代表含义:在多中心临床试验中负责协调参加各中心研究者工作的一名研究者。
监查员代表含义:由申办者任命并对申办者负责的具备相关知识的人员，其任务是监查和报告试验的进行情况和核实数据。
合同研究组织代表含义:一种学术性或商业性的科学机构。
申办者可委托其执行临床试验中的某些工作和任务，此种委托必须作出书面规定。
(完整)临床试验常用中英文词汇
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SFDA Glossary： GCP，GLP，TRIAL Accuracy 准确度Active control， AC 阳性对照，活性对照Adverse drug reaction， ADR 药物不良反应Adverse event， AE 不良事件Adverse medical events 不良医学事件Adverse reaction 药物不良反应Alb 白蛋白ALD（Approximate Lethal Dose）近似致死剂量ALP 碱性磷酸酶Alpha spending function 消耗函数ALT 丙氨酸氨基转换酶Analysis sets 统计分析的数据集Approval 批准Assistant investigator 助理研究者AST 天门冬酸氨基转换酶ATR 衰减全反射法AUCss 稳态血药浓度－时间曲线下面积Audit 稽查Audit or inspection 稽查／视察Audit report 稽查报告Auditor 稽查员Bias 偏性，偏倚Bioequivalence 生物等效应Blank control 空白对照Blind codes 编制盲底Blind review 盲态审核Blind review 盲态检查Blinding method 盲法Blinding/ masking 盲法，设盲Block 分段Block 层Block size 每段的长度BUN 尿素氮Carryover effect 延滞效应Case history 病历Case report form 病例报告表Case report form/ case record form， CRF 病例报告表,病例记录表Categorical variable 分类变量Cav 平均浓度CD 圆二色谱CL 清除率Clinical equivalence 临床等效应Clinical study 临床研究Clinical study report 临床试验的总结报告Clinical trial 临床试验Clinical trial application， CTA 临床试验申请Clinical trial exemption， CTX 临床试验免责Clinical trial protocol， CTP 临床试验方案Clinical trial/ study report 临床试验报告Cmax 峰浓度Co-investigator 合作研究者Comparison 对照Compliance 依从性Composite variable 复合变量Computer—assisted trial design， CATD 计算机辅助试验设计Confidence interval 可信区间Confidence level 置信水平Consistency test 一致性检验Contract research organization， CRO 合同研究组织Contract/ agreement 协议／合同Control group 对照组Coordinating committee 协调委员会Crea 肌酐CRF（case report form）病例报告表Crossover design 交叉设计Cross-over study 交叉研究Css 稳浓度Cure 痊愈Data management 数据管理Database 建立数据库Descriptive statistical analysis 描述性统计分析DF 波动系统Dichotomies 二分类Diviation 偏差Documentation 记录／文件Dose—reaction relation 剂量－反应关系Double blinding 双盲Double dummy 双模拟Double dummy technique 双盲双模拟技术Double—blinding 双盲Drop out 脱落DSC 差示扫描热量计Effectiveness 疗效Electronic data capture， EDC 电子数据采集系统Electronic data processing, EDP 电子数据处理系统Emergency envelope 应急信件End point 终点Endpoint criteria/ measurement 终点指标Equivalence 等效性Essential documentation 必须文件Ethics committee 伦理委员会Excellent 显效Exclusion criteria 排除标准Factorial design 析因设计Failure 无效，失败Final point 终点Fixed—dose procedure 固定剂量法Forced titration 强制滴定Full analysis set 全分析集GC－FTIR 气相色谱－傅利叶红外联用GC－MS 气相色谱－质谱联用Generic drug 通用名药Global assessment variable 全局评价变量GLU 血糖Good clinical practice， GCP 药物临床试验质量管理规范Good manufacture practice， GMP 药品生产质量管理规范Good non-clinical laboratory practice， GLP 药物非临床研究质量管理规范Group sequential design 成组序贯设计Health economic evaluation, HEV 健康经济学评价Hypothesis test 假设检验Hypothesis testing 假设检验International Conference of Harmonization， ICH 人用药品注册技术要求国际技术协调会，国际协调会议Improvement 好转Inclusion criteria 入选标准Independent ethics committee， IEC 独立伦理委员会Information consent form， ICF 知情同意书Information gathering 信息收集Informed consent, IC 知情同意Initial meeting 启动会议Inspection 视察／检查Institution inspection 机构检查Institution review board, IBR 机构审查委员会Intention to treat 意向治疗（——临床领域）Intention-to –treat， ITT 意向性分析（－统计学）Interactive voice response system， IVRS 互动式语音应答系统Interim analysis 期中分析Investigator 研究者Investigator's brochure， IB 研究者手册IR 红外吸收光谱Ka 吸收速率常Last observation carry forward， LOCF 最接近一次观察的结转LC－MS 液相色谱－质谱联用LD50 板数致死剂量Logic check 逻辑检查LOQ （Limit of Quantitation）定量限LOCF， Last observation carry forward 最近一次观察的结转Lost of follow up 失访Marketing approval/ authorization 上市许可证Matched pair 匹配配对Missing value 缺失值Mixed effect model 混合效应模式Monitor 监查员Monitoring 监查Monitoring report 监查报告MRT 平均滞留时间MS 质谱MS－MS 质谱－质谱联用MTD（Maximum Tolerated Dose）最大耐受剂量Multicenter trial 多中心试验Multi—center trial 多中心试验New chemical entity, NCE 新化学实体New drug application， NDA 新药申请NMR 核磁共振谱Non-clinical study 非临床研究Non-inferiority 非劣效性Non-parametric statistics 非参数统计方法Obedience 依从性ODR 旋光光谱Open-blinding 非盲Open-label 非盲Optional titration 随意滴定Original medical record 原始医疗记录Outcome 结果Outcome assessment 结果指标评价Outcome measurement 结果指标Outlier 离群值Parallel group design 平行组设计Parameter estimation 参数估计Parametric statistics 参数统计方法Patient file 病人档案Patient history 病历Per protocol， PP 符合方案集Placebo 安慰剂Placebo control 安慰剂对照Polytomies 多分类Power 检验效能Precision 精密度Preclinical study 临床前研究Primary endpoint 主要终点Primary variable 主要变量Principal investigator 主要研究者Principle investigator， PI 主要研究者Product license, PL 产品许可证Protocol 试验方案Protocol 试验方案Protocol amendment 方案补正Quality assurance unit， QAU 质量保证部门Quality assurance， QA 质量保证Quality control, QC 质量控制Query list， query form 应用疑问表Randomization 随机化Randomization 随机Range check 范围检查Rating scale 量表Regulatory authorities， RA 监督管理部门Replication 可重复RSD 日内和日间相对标准差Run in 准备期Safety evaluation 安全性评价Safety set 安全性评价的数据集Sample size 样本含量Sample size 样本量，样本大小Scale of ordered categorical ratings 有序分类指标Secondary variable 次要变量Sequence 试验次序Serious adverse event， SAE 严重不良事件Serious adverse reaction, SAR 严重不良反应Seriousness 严重性Severity 严重程度Significant level 检验水准Simple randomization 简单随机Single blinding 单盲Single-blinding 单盲Site audit 试验机构稽查SOP 试验室的标准操作规程Source data verification， SDV 原始数据核准Source data， SD 原始数据Source document, SD 原始文件Specificity 特异性Sponsor 申办者Sponsor—investigator 申办研究者Standard curve 标准曲线Standard operating procedure， SOP 标准操作规程Statistic 统计量Statistical analysis plan 统计分析计划Statistical analysis plan 统计参数计划书Statistical analysis plan， SAP 统计分析计划Statistical model 统计模型Statistical tables 统计分析表Stratified 分层Study audit 研究稽查Subgroup 亚组Sub-investigator 助理研究者Subject 受试者Subject diary 受试者日记Subject enrollment 受试者入选Subject enrollment log 受试者入选表Subject identification code， SIC 受试者识别代码Subject recruitment 受试者招募Subject screening log 受试者筛选表Superiority 检验Survival analysis 生存分析SXRD 单晶X－射线衍射System audit 系统稽查T1/2 消除半衰期Target variable 目标变量T－BIL 总胆红素T－CHO 总胆固醇TG 热重分析TLC、HPLC 制备色谱Tmax 峰时间TP 总蛋白Transformation 变量变换Treatment group 试验组Trial error 试验误差Trial master file 试验总档案Trial objective 试验目的Trial site 试验场所Triple blinding 三盲Two one—side test 双单侧检验Unblinding 揭盲Unblinding 破盲Unexpected adverse event， UAE 预料外不良事件UV－VIS 紫外－可见吸收光谱Variability 变异Variable 变量Visual analogy scale 直观类比打分法Visual check 人工检查Vulnerable subject 弱势受试者Wash—out 清洗期Washout period 洗脱期Well-being 福利，健康。
临床实验注册的英文版
临床实验注册的英文版Registration of Clinical Trials: English VersionIntroduction:Clinical trials play a crucial role in advancing medical knowledge and improving patient care. However, it is essential to ensure transparency and accountability in the conduct of these trials. The registration of clinical trials is a pivotal step, providing important information to researchers, healthcare professionals, and the public. In this article, we will discuss the significance of clinical trial registration and guidelines for registering trials in English.Importance of Clinical Trial Registration:1. Enhancing Transparency:Clinical trial registration serves as a means to enhance transparency in medical research. Registered trials provide detailed information about the study design, methods, interventions, and outcomes, enabling researchers to evaluate the robustness of the trial and replicate the findings if necessary.2. Prevention of Publication Bias:Registration of clinical trials helps to prevent publication bias, where only positive or statistically significant results are published, while negative or inconclusive results remain unpublished. By registering all trials, regardless of their outcomes, researchers and healthcare professionals gain access to a comprehensive database of trial information, enabling a more accurate assessment of the effectiveness and safety of interventions.3. Avoiding Duplication:Registered trials allow researchers to determine whether a specific research question has been previously addressed, avoiding unnecessary duplication of efforts. This ensures that resources are effectively utilized, maximizing the impact of clinical research.4. Protecting Research Participants:Clinical trial registration helps to protect research participants by providing an overview of ongoing trials. Potential participants can review the registered trials to assess whether they may be eligible to participate, further emphasizing the principles of informed consent and patient autonomy.Guidelines for Registering Clinical Trials in English:1. Choose a Recognized Registry:Select a reputable clinical trial registry that is compliant with international standards. The World Health Organization's International Clinical Trials Registry Platform (ICTRP) is a widely recognized example. Ensure that the selected registry allows registration of your trial in the English language.2. Provide Detailed Trial Information:When registering your clinical trial in English, it is essential to provide comprehensive information to facilitate clear understanding. The following details should be included:a. Trial Identification: Register a unique trial identification number to distinguish your trial from others.b. Title and Acronym: Provide a concise and informative title for your trial, along with any relevant acronyms.c. Study Design: Describe the study design, including the type of trial (e.g., randomized controlled trial, observational study), allocation, blinding, and any special considerations (e.g., crossover design).d. Interventions: Clearly specify the interventions being evaluated, including the dosage, duration, and administration details.e. Participants: Describe the target population and eligibility criteria for enrollment, including age range, gender, and any specific medical conditions or previous treatments required or excluded.f. Outcomes: List the primary and secondary outcomes that will be measured in the trial, along with the relevant assessment methods.g. Ethics and Informed Consent: Detail the ethical considerations involved in the trial, including ethical review board approval and informed consent procedures.h. Funding and Sponsorship: Disclose any financial support or sponsorship received for the trial.i. Contact Information: Provide contact details for the principal investigator or study coordinator for inquiries or collaborations.3. Regularly Update Trial Information:As the trial progresses, ensure to update the registered information promptly. Any modifications or amendments to the trial protocol should beduly recorded. Regular updates will provide accurate and up-to-date information to interested parties.Conclusion:Clinical trial registration in the English language is essential to promote transparency, prevent publication bias, avoid duplication of efforts, and protect research participants. Following guidelines for registering trials in English, such as choosing a recognized registry and providing detailed trial information, ensures a comprehensive and useful database for researchers, healthcare professionals, and the public. By adhering to the principles of clinical trial registration, we facilitate the advancement of medical knowledge and contribute to improved patient care.。
制药公司职位岗位设置
三天两头看到“绝望求助帖”，本来想跟帖的，不过过不了一会儿帖子就会沉没在口水中，于阅者无益。
难得有空有闲，想想还是单开一贴扫扫盲，欢迎行内人纠正补充，如果有不同意见，请举证反驳，七姑八姨的传说或者朋友的邻居的朋友的故事就不用搬出来了，因为那都没多少credit。
新药的研制是一个复杂的工程，涉及的常见project有来自于CMC（chemical, analytical, and controls),chemical synthesis (exclusive), clinical trial,regulatory affair等等。
理论上，所有这些都和生物沾边，即便是regulatory affair。
要展开来细讲，每个话题的篇幅都不会少。
对于大伙来说，最熟悉的莫过于R&D，一个很笼统的说法涵盖了compound screening, preclinical以及clinical trial。
很多大家感兴趣的词包括CRA, CRO等等也都囊括其中。
所以细节留着以后有时间再添加，这里先笼统的介绍介绍“如雷贯耳”的R&D。
新药研发的两个主要的phase，其中之一便是research，顾名思义，一堆垃圾中挑金子(lead compound)，当然不是胡挑，而是有in vitro和animal model来support的。
另一个phase便是development，在lead compound选出来之后要经过nonclinical以及clinical trial来检验efficacy和safety，其中nonclinical/preclinical 是做safety evaluation in animal 以及drug product formulation for Phase I等等；phase 1是在健康人群里检验（短时间小样本），检验不同的dosage以及acute tolerability；phase 2是在挑选的病人里检验，完成dosage的选择以及要得到相对完善的safety资料；phase 3最昂贵，大样本长周期，是在general patient里测试，要取得完整的efficacy和safety资料，尽可能和市场上的competitor drug做比较trial。
世界卫生组织药品临床试验管理规范指南
世界卫生组织药品临床试验管理规范指南引言此WHO临床试验管理规范指南的目的是为在人体进行生物医学研究而建立的、供全球采用的标准。
它是以一些高度发达国家包括澳大利亚、加拿大、欧洲共同体国家、日本、北欧国家和美国已颁布的规定为基础的，不可避免地在内容和侧重点上与这些国家的临床试验管理规定有所不同，但为保证道德上和科学上的完整性，临床试验所需满足的先决条件和应用的原则是相一致的。
事实上，它已经为对此感兴趣的国家的临床数据的相互承认提供了一种正式的基础。
为了WHO成员国在更广泛一致的合作中，使用本指南作为一种实用的管理工具，本指南已尽量保证与已经存在的国家法规与其他法规相容而无抵触。
希望在进一步磋商的基础上，使WHO各成员国能正式接受本指南，为协调国际标准和促进药品国际间转移做出贡献。
但是，它并不存在向各国已有的法规或要求提出非议或侵占的问题。
它的目的只是提供一个国际上有效的补充标准。
本指南不仅论及研究者，也论及伦理审查委员会、药品制造商和其他的研究申办者以及药品管理当局。
本指南，既为涉及人体的研究在科学上和道德上的完整性，也为有效的观察和对发现做出充分的记录提供了基础，不仅为积极参与研究的各方的利益服务，也保护受试者的权利和安全，包括病人，保证研究者执行试验以公众利益为指导。
本指南特别希望被用于药物研究的各个阶段，即在产品注册之前和注册之后，它的全部或部分也可用于一般的生物医学研究。
本指南为主编们决定是否接受要发表的被报告的研究提供一种支持，尤其是对影响药物注册的任何临床研究提供支持。
更重要的是，本指南为从事生物医学研究的人和新培养的医师提供了一种教育工具，他们应该熟悉之。
术语以下为本指南中术语专用的定义。
在其他文件中它们可以有不同的涵义。
［不良事件］（Adverse event）指在接受一种药品治疗期间发生的任何不良的医疗事件，但不一定与该治疗有因果关系。
［不良反应］（Adverse reaction）指对一种药物的反应，对人体是有害的，非意求的，可能出现在用于预防、诊断、治疗疾病或改变生理功能的正常剂量时。
clinicaltrial 介绍
clinicaltrial 介绍
临床试验是指医学研究中用于评估新药物、治疗方法或医疗器
械安全性和有效性的研究过程。
临床试验通常分为四个阶段，即临
床前研究、临床试验阶段Ⅰ、Ⅱ和Ⅲ，以及上市后监测。
在临床试
验中，研究人员通过招募志愿者，将新药物或治疗方法应用于实际
患者，收集数据并进行分析，以评估其对疾病的治疗效果和安全性。
临床试验的目的包括评估新药物或治疗方法的安全性、有效性
和剂量，比较新治疗方法与标准治疗的效果，了解治疗方法对不同
人群的适用性，以及评估治疗方法的长期影响。
临床试验的结果对
于指导临床实践和药物监管具有重要意义。
在临床试验中，研究人员需要遵守严格的伦理规范和法律法规，确保志愿者的权益和安全受到保护。
临床试验通常需要经过伦理委
员会和监管机构的批准，确保研究设计科学合理，风险得到最小化，潜在好处得到最大化。
总的来说，临床试验是评估新药物和治疗方法安全性和有效性
的重要手段，对于推动医学进步和改善患者治疗效果具有重要意义。
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EU Legislation
EU Clinical Trials Directive 2001/20/EC
UK Legislation
Medicines for Human Use (Clinical Trials) Regulations 2004 (SI 1031)
‘Guidance’
EC Commission Eudralex – Volume 10 Clinical Trial guidelines ICH GCP Topic E6 – Good Clinical Practice Research Governance Framework for Health and Social Care Organisation/Sponsor SOPs
What is all the fuss about?
• Prior to 2004 the standards were guidelines and dual standards existed • For the first time ethical and scientific standards for the set up, and conduct of clinical research involving human subjects receiving investigational medicinal products, became subject to law
Good Clinical Practice in Research
Clinical Trial Regulations
Zoe Whale / Lynette Lane GCP Facilitators, NISCHR CRC
Objectives
At the end of this session, I hope you will be able to: •Understand there is a set of interwoven laws, guidelines and frameworks which govern the set up and conduct of clinical research • Understand what CTIMP and non-CTIMP studies are, the differences between them and the regulatory requirements which govern their conduct •See GCP as a ‘live’ subject which is about continually improving the way things are done •Share your experiences of applying GCP to your own research field
EU GCP Directive 2005/28/EC
Medicines for Human Use (Clinical Trials) Amendment Regulations 2006 (SI 1928)
Amendment 2006 (SI 2964) Amendment 2008 (SI 941) Amendment 2009 (SI 1164) Amendment 2010 (SI 1882)
Examples
Can anyone give me examples of ‘bad’ or ‘poor’ research?
Standards in Research are not new
Ethical standards to protect people have been around for over 60 years
Research Governance Framework for Health and Social Care in Wales 2009
• The framework applies to all research that relates to the responsibilities of the Secretary of State for Health • “… research concerned with the protection and promotion of public health, research undertaken in or by the Department of Health, its non Departmend research undertaken by or within social care agencies. It includes clinical and non-clinical research” The framework is not law but must be adhered to for all studies conducted in Wales
European Directives & UK Laws
• EU Directives are legislation issued by the European Union defining an outcome or change that is binding for each member state • EU Directives must be transposed into law in each member state to become law in that country
What is the significance of regulation and standards in clinical research?
• Safeguard and protect research subjects
• Risk reduction • Quality data/outcomes • Excellent research, good science