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Research Governance Documentation and Information Guide


The UK Medicines for Human Use (Clinical Trials) Regulations 2004 implement the EU Clinical Trials Directive in the UK. The main aim of the Directive is to simplify and harmonise the administrative provisions governing clinical trials on medicinal products for human use, by establishing a clear, transparent procedure and creating conditions conducive to the effective co-ordination of such clinical trials in the European Community. Overall, the Directive aims to provide an environment for conducting clinical research that protects participants without hampering the discovery of new essential medicines. ‘The Medicines for Human Use (Clinical Trials) Regulations came into force on 1 May 2004.

Useful Websites:

European Commission - Pharmaceuticals  

European Commission - Medical Devices

European Commission - Biotechnology

European Commission - the EU Pharmacovigilance system

MHRA - Medicines & Healthcare Products Regulatory Agency 

The Clinical Trials Tool Kit

a) European Commission and UK Government Documents

The Clinical Trials Directive 2001/20/EC
The laws, regulations and administrative provisions for the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use

Implementing Texts for Directive 2001/20/EC
A range of detailed guidance documents covering requirements concerned with the implementation of the Directive.

GCP Directive 2005/28/EC
Principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products

Commissioning Directive 2003/94/EC Good Manufacturing Practice (GMP)

This Directive lays down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use

The Medicines for Human Use (Clinical Trials) Regulations 2004
Statutory Instrument 2004 No. 1031.

The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006
Amends SI 2004/1031 to incorporate the GCP Directive. In force from 29 August 2006.

Explanatory memorandum

European Clinical Trials Database (EudraCT)

Database of all clinical trials commencing in the Community from 1 May 2004 onwards. It has been established in accordance with Directive 2001/20/EC. This site allows the sponsor to: get a EudraCT number and complete, save as a .xml file on your computer and print a pdf version of the clinical trial application form.

b) The Medicines and Healthcare products Regulatory Agency (MHRA)

MHRA is an Executive Agency of the Department of Health.  Its role is to protect and promote public health and patient safety by ensuring that medicines, healthcare products and medical equipment meet appropriate standards of safety, quality, performance and effectiveness, and are used safely.  The MHRA is the regulatory body responsible for clinical trials authorisation (CTA)

MHRA Clinical Trials Directive section
Gateway to all the MHRA regulatory guidance around clinical trials authorisation

The Clinical Trials Unit is part of the Licensing Division of the Medicines branch of the MHRA. The role of the Unit is to assess applications from sponsors to conduct clinical trials with medicinal products.

Description of the Medicines for Human Use (Clinical Trials) Regulations 2004
A description of all the changes to UK clinical trials practice and legislation, a summary of some of the benefits to public health and a short description of each of the Regulations

Clinical Trials Authorisations - legislation and guidance documents

A comprehensive page of links to clinical trials legislation, guidance documents, databases, information from MHRA and other useful sites.

Is it a Clinical Trial?
Algorithm developed by the MHRA to help researchers find out whether a project comes within the Medicines for Human Use (Clinical Trials) Regulations 2004

Clinical Trial Authorisation
Flowchart and accompanying guidance on applying for clinical trial authorisation authorisation to conduct a clinical trial on a medicinal product for human use


c) The Clinical Trials Tool Kit

In July 2004 the MRC and DH agreed to collaborate on a joint project to document best practice in publicly and charitably funded clinical trials of medicines, for the benefit of the trials and R&D management communities and the MHRA. The Clinical Trials Tool Kit brings together and disseminates the work of the Joint Project including legislation, guidance and good practice on the regulations. The information is particularly relevant to all publicly funded research in the NHS and is aimed primarily at investigators, trial managers and NHS R&D staff.

Clinical Trials Tool Kit
A website with practical help in meeting the requirements of the UK Medicines for Human Use (Clinical Trials) Regulations 2004. Designed for clinical trialists and R&D managers in the academic sector but will be of use to other health professionals.

Register to receive email updates covering what’s new on the Clinical Trials Toolkit site

Clinical Trials Tool Kit – Route maps
Route maps are designed to help people involved in the management of clinical trials. The maps have links to guidance and resources designed to support both statutory requirements and good practice.


Notes on Good Practice for Research Organisations in the Management of a Portfolio of Trials (last updated 5 October 2004)

Three documents containing useful information and guidance on research management, risk assessment and management of risk – the principles are useful for research active organisations whatever level of research activity they support.

1. Introduction and summary of primary risks to a research active organisation

2. Assessment of Risk

3. Management of risk and recommendations for the future





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page last updated

November 13, 2008

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