最后更新: 八月 17, 2026

良好临床实践指南

 

 

What is the ‘Good Clinical Practice Guide’?

MHRA 为何决定发布该指南?

为什么该指南很重要以及它将如何提供帮助?

该指南如何与现有的指导和法规相适应?

Who was involved in producing the Guide and how was the content decided?

How is the Guide structured?

The Guide contains a number of examples – are these fictional (to illustrate a point) or do they reflect real practice?

Is the guide only relevant to researchers in the UK?

How is the Guide available?

What is the ‘Good Clinical Practice Guide’?

The ‘Good Clinical Practice Guide’ is a brand new publication covering the legislation, guidance and good practice that relates to the conduct of clinical trials of medicinal products for human use in the UK.

 

MHRA 为何决定发布该指南?

This came from feedback from our stakeholders, who felt that there was a lack of comprehensive and authoritative guidance on how the clinical trial regulations, and in particular GCP principles, should be implemented in practice.

 

为什么该指南很重要以及它将如何提供帮助?

There are differences in terms of structure, 组织, 资源, experience and approach between all those involved in conducting clinical trials and therefore the way in which organisations can achieve compliance varies immensely; what is appropriate for one may be hugely unrealistic or unnecessary for another. A ‘one size fits all’ approach to conducting clinical trials does not work successfully across the wide range of trials conducted in the UK.

 

It is intended that this guide will complement currently available legislation and guidance and provide practical examples of how the GCP principles apply and how they may be met in a variety of different scenarios. The Guide also demonstrates that a proportionate and risk-adapted approach can be taken to trials that are considered to be lower-risk.

该指南如何与现有的指导和法规相适应?

There are a number of regulations and guidance documents that govern clinical trials. The European Clinical Trials Directive (2001/20/欧共体) is the key piece of legislation, and this has been transposed into UK law via Statutory Instrument 2004/1031. 此外, the European Commission and the European Medicines Agency have developed a number of guidance documents that offer further details on how to comply with the legislation.

The GCP Guide fits very well alongside these documents, and they are referred to throughout the Guide. What the GCP Guide additionally offers is practical guidance and recommendations on how the legislation can be met.

MHRA 的类似指导文件也适用于其他领域的良好实践 (GxP): 《良好药物警戒实践指南》 (“紫色指南”), “药品制造商和经销商的规则和指南” (“橙色指南”), “英国 GLP 法规指南”和“良好分销实践指南”

Who was involved in producing the Guide and how was the content decided?

该指南从 GCP 检查机构内部讨论开始, 谁根据检查中常见问题提出纳入主题. 随后该指南开放供外部咨询 (使用调查问卷和 GCP 咨询委员会) 确保内容满足利益相关者的需求.

 

该指南的制作是一项巨大的协作努力. Firstly the entire GCP inspectorate was involved in reviewing the Guide as well as authoring the majority of the chapters. The Clinical Trials Unit and the Statistics Unit of the MHRA Licensing Division, other sections of the Inspectorate (GMP/GDP, GPvP and GLP) as well as the National Research Ethics Service also authored chapters and reviewed parts of the Guide. The Guide has also been reviewed by stakeholders from industry and academia, as well as other inspectors from other European Member States.

 

How is the Guide structured?

It is divided into the following chapters and annexes, which cover all the different areas of clinical trials:

 

1. Sponsor Oversight

2. Clinical Trial Authorisations

3. Ethical Review

4. Key Trial Documentation

5. Pharmacovigilance for Clinical Trials

6. 研究药物产品

7. 监控

8. 数据管理

9. 统计数据

10. Trial Master File and Archiving

11. Investigator Sites

12. I期临床试验

13. Clinical Trial Samples – 分析与评价

14. 质量体系

附件 1: GCP 检查简介

附件 2: 相关立法和指导

附件 3: 先进疗法研究性药品试验

附件 4: 在临床试验管理中使用电子系统的注意事项

The Guide contains a number of examples – are these fictional (to illustrate a point) or do they reflect real practice?

该指南的一个关键组成部分是大量优秀的实际例子 (和穷人!) 与进行临床试验相关的实践. 所有这些例子都是真实的, 并在工作过程中被检查员看到.

 

Is the guide only relevant to researchers in the UK?

该指南主要针对英国研究人员; 然而，随着英国立法解释欧洲立法, GCP 指南的大部分内容也与其他欧洲成员国相关. 指南中讨论的一些基本原则和良好实践示例也适用于欧洲以外的地区，因此这可能是非欧洲国家的有用工具.