UK Clinical Trials Regulations

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

• Laid before Parliament 1 April 2004
• Came into force 1 May 2004
• Implementation of the the EU Clinical Trials Directive (2001/20/EU) and GMP (Good Manufacturing Practice) requirements into UK law
• Sometimes referred to as the Principal Regulations

 “The Regulations provide a statutory basis for:
• Standardisation of procedures for ethical and competent authority consideration and authorisation
• GCP standards for commencing and conducting clinical trials
• Good Manufacturing Practice (GMP) standards for medicines used in clinical trials
• Inspections against internationally accepted principles and standards of GCP and GMP, supported by enforcement powers.” 
                                                                         from MHRA website      

Relevant Links: Full Text of the Regulations
http://www.opsi.gov.uk/si/si2004/20041031.htm

A Description of the Regulations by the MHRA
http://www.mhra.gov.uk/home/groups/l-unit1/documents/websiteresources/con2022633.pdf

 

SI 2006 No.1928 The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006

• Laid before Parliament 20 July 2006
• Came into force 29 August 2006
• Implementation of the EU GCP Directive  (2005/28/EC)  which was published by the European Commission in 2005
• Sometimes referred to as the Amendment Regulations

Key points from the Amendment Regulations include:
• Sponsor may delegate some /all of his functions but remains responsible
• Sponsor to ensure that the Investigators Brochure (IB) is clear, concise and unbiased, vaildated and updated annually. If IMP already has marketing authorisation in UK, then its Summary of Product Characteristics (SmPC)  will be used instead of IB
• Sponsor must notify MHRA of any serious breach of protocol or GCP within 7 days
• Sponsor must maintain a Trial Master File (TMF) containing all Essential Documents (to be available for inspection), appoint named archivist and ensure retention for at least 5 years after the end of the trial
• Trial participants medical records also to be retained for at least 5 years after end of trial
• Ethics Committee Documents to be retained for at least 3 years after end of trial
• Conditions and principles of GCP revised

Other changes included in the amendment regulations relate to payment of fees, extension of warning notices, obligations of ethics committees, sharing of information between ethics committees and licensing authority, and other minor corrections.

Relevant Links: Full Text of the Amendment Regulations AND Explanatory Note
http://www.opsi.gov.uk/si/si2006/20061928.htm

 

SI 2006 No.2984 The Medicines for Human Use (Clinical Trials) Amendment (No.2) Regulations 2006

• Laid before Parliament 21 November 2006
• Came into force 12 December 2006
• Amends both the Clinical Trials Regulations and the Adults with Incapacity (Scotland) Act 2000

The Amendment (No.2) Regulations make it possible to include a subject in a clinical trial who is an incapacited adult (e.g. an unconscious patient in an emergency medicine trial) without the consent of a legal representative, if a number of conditions are met regarding the nature of the trial, the urgency for treatment and the circumstances where it is not reasonably practicable to obtain consent from either a personal or professional legal representative. It should be noted that the procedure to be followed in these circumstances must have Ethics Committee Approval.

Relevant Links: Full Text of the Amendment Regulations AND Explanatory Note
http://www.opsi.gov.uk/si/si2006/uksi_20062984_en.pdf

SI 2008 No.941 The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality Amendment Regulations 2008

• Laid before Parliament  7 April 2008
• Came into force 1 May 2008

Key Points
• Allows for children to be included in certain emergency care trials without the consent of parent or legal representative, provided certain conditions are met and approved by ethics committee. This is similar to the 2006 amendment for adults with incapacity. 
• Removes obligation for Gene Therapy Advisory Committee (GTAC) expert advice for routine gene therapy trials allowing GTAC to inform the UK Ethics Committee Authority (UKECA) that routine gene therapy trials can be referred to other ethics committee for review and approval. 
• Amendments to Ethics Committees' administrative operating procedures                                               

(This statutory instrument also amends the Blood Safety and Quality Regulations - not relevant to Clinical Trials)

Relevant Links: Full Text

http://www.opsi.gov.uk/si/si2008/uksi_20080941_en_1

Explanatory Memorandum

http://www.opsi.gov.uk/si/si2008/em/uksiem_20080941_en.pdf

SI 2009 No.1164 The Medicines for Human Use (Miscellaneous Amendments) Regulations 2009

• Laid before Parliament 7 May 2009
• Came into force 8 May 2009
• Amends Regulation 30 of the Clinical Trials Regulations  relating to urgent safety measures.
 

'Allows for notice of urgent safety measures (taken in order to protect the subjects of a clinical trial against any immediate hazard to their health or safety and the circumstances giving rise to those measures) to be given as soon as possible to the licensing authority and an ethics committee established under Part 2 of those Regulations during a period in which a disease is pandemic and is a serious risk to human health or potentially a serious risk to human health.'                                        

Relevant Links: Full Text and explanatory note as above
http://www.opsi.gov.uk/si/si2009/uksi_20091164_en_1