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, organisation, 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.

Similar guidance documents from the MHRA exist for other areas of good practice (GxP): ‘The Good Pharmacovigilance Practice Guide’ (‘Purple Guide’), ‘Rules and guidance for pharmaceutical manufacturers and distributors’ (‘Orange Guide’), the ‘Guide to UK GLP Regulations’ and the ‘Good Distribution Practice Guide’

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

The Guide started off with internal discussions among the GCP Inspectorate, who proposed topics for inclusion based on issues they commonly saw on inspection. Then the Guide was opened up for external consultation (using questionnaires and the GCP Consultative Committee) to ensure that the content would meet the needs of the stakeholders.

 

The production of the Guide was a large collaborative effort. 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 – Analysis and Evaluation

14. 质量体系

附件 1: Introduction to GCP Inspections

附件 2: Relevant legislation and guidance

附件 3: Advanced Therapy Investigational Medicinal Product Trials

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?

A key component of the Guide is the large number of practical examples of good (和穷人!) practice in relation to conducting clinical trials. All these examples are real, and have been seen by inspectors in the course of their work.

 

Is the guide only relevant to researchers in the UK?

The Guide is primarily aimed at UK researchers; however as the UK legislation interprets the European Legislation, much of the GCP Guide will also be relevant to other European Member States. Some of the basic principles and good practice examples discussed in the guide will also be applicable beyond Europe and therefore this could be a useful tool in non-European countries.