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Summary of Clinical Trial Regulations Amendments

This summary should be used as guidance only. It is recommended that you view the full amendments.

The Medicines for Human Use (Clinical Trials) Amendment (No.1) Regulations SI (2006/1928)

Key points include:

  • The Sponsor of a Clinical Trial may delegate any or all of its functions to any person but the functions will remain the responsibility of the Sponsor.
  • The Sponsor is responsible for ensuring that the Investigator's Brochure is easily understandable and unbiased and that it is validated and updated at least once a year.
  • The MHRA and ethics committee may disclose information to each other, regarding the trial in question, in order to assist their respective functions.
  • The Sponsor must notify the MHRA in writing within 7 days of any serious breaches of the conditions and principles of Good Clinical Practice and/or the protocol, in relation to the trial. A serious breach is a breach which is likely to affect to a significant degree: the scientific value of the trial; the safety and/or physical and/or mental integrity of the trial participants.
  • The Sponsor shall keep a Trial Master File (TMF) for a trial and ensure it is readily available for inspection or audit. The TMF will contain the essential documents relating to all phases of a clinical trial to: enable the conduct of the clinical trial and quality of the data produced to be evaluated; and provide evidence of the trial being conducted in accordance with the applicable regulatory requirements. Any alteration to a document must also remain in the TMF to provide an audit trail. The Sponsor and CI will ensure that all documents contained in the TMF and/or trial subject file are retained for at least five years after trial conclusion and are readily available to the MHRA on request. This will remain the responsibility to an appointed individual.

View the full text and explanatory note here:

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

Key points include:

  • The Amendment (No.2) Regulations make it possible to include a subject in a clinical trial who is an incapacitated adult 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.

View the full text and explanatory note here:

The Medicines for Human Use (Clinical Trials) and Blood Safety and Quality (Amendment) Regulations SI (2008/941)

Key points include:

  • An ethics committee may give a favourable opinion subject to conditions specified in writing in relation to a clinical trial. If an ethics committee gives a favourable opinion subject to conditions, the ethics committee is to be treated as having given a favourable opinion in relation to the clinical trial only if the specified conditions are satisfied.
  • Removes the requirement for the Gene Therapy Advisory Committee (GTAC) to give an opinion on applications that do not merit an expert opinion from the GTAC. Such applications will be referred to other ethics committees for review and approval.
  • Allows minors to be entered in to a trial prior to consent having been obtained from a person with parental responsibility or legal representative in trials of emergency medicines where certain conditions are met and approval is obtained from the relevant ethics committee. This is similar to the 2006 amendment for adults with incapacity.

View the full text and explanatory note here:

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

Key points include:

  • 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.

View the full text and explanatory note here: