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Standard Process: Specific for trials within Directive's scope |
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Legal Requirement: Specific for trials within Directive's scope |
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Good Practice: Specific for trials within Directive's scope |
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Standard Process: Relevant to all trials |
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Legal Requirement: Relevant to all trials |
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Good Practice: Relevant to all trials |
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Is the trial within the scope of the UK Regulations ?
There are a number of steps to follow before a trial can commence. The first step is to confirm that the trial falls within the scope of the UK Regulations. If it does, then the trial protocol should be written and funding sought, if required, with the regulations in mind. A Sponsor must be identified and a EudraCT number obtained, followed by authorisation from MHRA (Clinical Trial Authorisation) and approval by an Ethics Committee. R&D approval is also required before a trial can commence in any clinical site. These steps can be done in parallel.
Trials that are outside the scope of the UK Regulations must still comply with the NHS Research Governance Framework. A Sponsor must be identified and approval obtained from an Ethics Committee and relevant NHS R&D departments.
MHRA have released an algorithm to help you determine if your trial falls with in the scope of the Directive. See the first resource below.
Resources
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MHRA Algorithm to help determine if your trial falls with in the scope of the Directive.
(Last Updated 30 Apr 2010)
Stations this resource found in: Is the trial within the scope of the UK regulations?, Is the trial within the scope of the UK Regulations ?
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FAQs: Are all clinical trials covered by the Regulations?
Description of the type of trials that are with in the scope of the EU Directive.
(Last Updated 24 Sep 2004)
Stations this resource found in: Is the trial within the scope of the UK regulations?, Is the trial within the scope of the UK Regulations ?
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Email address to contact MHRA.
(Last Updated 23 Sep 2004)
Stations this resource found in: Is the trial within the scope of the UK regulations?, Is the trial within the scope of the UK Regulations ?, Definition of an Ongoing Trial
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Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001
Directive 2001/20/EC of the European Parliament and of the Council of 4 April 2001 on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use.
Link to download the EU Clinical Trials Directive.
This Directive is a legal requirement for EU member states, in the UK the Medicines for Human Use (Clinical Trials) Regulations 2004, is the legal document.
(Last Updated 30 Apr 2010)
Stations this resource found in: Is the trial within the scope of the UK regulations?, Is the trial within the scope of the UK Regulations ?, Identify Sponsor(s) (New Trials), Sponsorship, Identify Sponsor(s)
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Medicines for Human Use (Clinical Trials) Regulations 2004
The Statutory Instrument transposing the EU Clinical Trials Directive in to UK law on 1st May 2004.
(Last Updated 19 Oct 2005)
Stations this resource found in: Is the trial within the scope of the UK Regulations ?, Identify Sponsor(s) (New Trials), Sponsorship, Identify Sponsor(s)
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Research Governance Framework 2nd Edition
DH publishes the 2nd edition of the Research Governance Framework for Health and Social Care
(Last Updated 26 May 2005)
Stations this resource found in: Is the trial within the scope of the UK Regulations ?, Identify Sponsor(s) (New Trials), Sponsorship
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Research Governance Framework for Health and Social Care for Wales, 2nd edition 2009
Link to Research Governance Framework for Health and Social Care for Wales. These guidelines are mandatory for all research involving NHS patients.
(Last Updated 18 Nov 2009)
Stations this resource found in: Is the trial within the scope of the UK Regulations ?, Identify Sponsor(s) (New Trials), R&D Submission, Sponsorship
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Research Governance Framework for Health and Community Care for Scotland
Link to Research Governance Framework for Health and Community Care for Scotland (2nd edition). These guidelines are mandatory for all research involving NHS patients.
(Last Updated 21 Dec 2006)
Stations this resource found in: Is the trial within the scope of the UK Regulations ?, Identify Sponsor(s) (New Trials), R&D Submission, Sponsorship
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Research Governance Framework for Health and Social Care for Northern Ireland
Link to Research Governance Framework for Health and Social Care for Northern Ireland. These guidelines are mandatory for all research involving NHS patients.
(Last Updated 19 Sep 2006)
Stations this resource found in: Is the trial within the scope of the UK Regulations ?, Identify Sponsor(s) (New Trials), R&D Submission, Sponsorship
