(1) If a sponsor or investigator gives notice under paragraph 3(1)(a) of his wish to appear before or be heard by a person appointed by the licensing authority, the authority shall—

(a) make that appointment; and

(b) arrange for the sponsor or investigator to have an opportunity of appearing before the person appointed by the licensing authority.

(2) The person appointed—

(a) shall not be, or at any time have been, a member of—

(i) the Commission on Human Medicines,

(ii) an expert committee appointed by the licensing authority,

(iii) an expert advisory group within the meaning of regulation 14 of the 2012 Regulations,

(iv) the British Pharmacopoeia Commission referred to in regulation 11 of the 2012 Regulations, or any of its sub-committees,

(v) the Medicines Commission formerly established under section 2 of the Act, or any of its committees,

(vi) the Advisory Board on the Registration of Homoeopathic Products formerly established under section 4 of the Act, or any of its sub-committees, or

(vii) the Herbal Medicines Advisory Committee formerly established under section 4 of the Act, or any of its sub-committees, and

(b) shall not be an officer or servant of a Minister of the Crown , the Scottish Ministers, the Welsh Ministers or a Northern Ireland Minister.

(3) Subject to sub-paragraph (4), the sponsor or investigator shall provide the person appointed with—

(a) a written summary of the oral representations he intends to make; and

(b) any documents on which he wishes to rely in support of those representations,

before the end of the period of three months beginning with the date of the notice referred to in sub-paragraph (1).

(4) If the sponsor or investigator so requests, the person appointed may, after consulting the licensing authority, extend the time limit referred to in sub-paragraph (3), up to a maximum period of six months beginning with the date of the notice referred to in sub-paragraph (1).

(5) If the sponsor or investigator fails to comply with the time limit in sub-paragraph (3) or, where he has been granted an extended time limit under sub-paragraph (4), that time limit—

(a) he may not appear before or be heard by the person appointed; and

(b) the licensing authority shall decide whether to confirm or alter their decision.

(6) The sponsor or investigator may not submit any additional written representations or documents once the time limit has expired, except with the permission of the person appointed.

(7) At the hearing before the person appointed, both the sponsor or investigator and the licensing authority may make representations.

(8) If the sponsor or investigator so requests the hearing shall be in public.

(9) After the hearing—

(a) the person appointed shall provide a report to the licensing authority; and

(b) the licensing authority shall take this report into account and decide whether to confirm or alter their decision.

(10) The licensing authority shall then—

(a) notify the sponsor or investigator of their decision;

(b) if the sponsor or investigator so requests, provide him with a copy of the report of the person appointed.

3A

The sponsor of a clinical trial shall—

(a) ensure that the investigator’s brochure for that trial, and any update of that brochure, presents the information it contains in a concise, simple, objective, balanced and non-promotional form that enables a clinician or potential investigator to understand it and make an unbiased risk-benefit assessment of the appropriateness of the proposed clinical trial; and

(b) validate and update the investigator’s brochure at least once a year.

Responsibility for functions under the Directive

27A

The licensing authority and an ethics committee may disclose to each other any information acquired in carrying out their respective functions under these Regulations where disclosing such information may assist the other body in carrying out its functions under these Regulations.

Notification of serious breaches

29A

(1) The sponsor of a clinical trial shall notify the licensing authority in writing of any serious breach of—

(a) the conditions and principles of good clinical practice in connection with that trial; or

(b) the protocol relating to that trial, as amended from time to time in accordance with regulations 22 to 25,

within 7 days of becoming aware of that breach.

(2) For the purposes of this regulation, a “serious breach” is a breach which is likely to effect to a significant degree—

(a) the safety or physical or mental integrity of the subjects of the trial; or

(b) the scientific value of the trial.

Urgent safety measures

Suspension or termination of clinical trial

Trial master file and archiving

31A

(1) The sponsor shall keep a trial master file for a clinical trial.

(2) The sponsor shall ensure that the trial master file is readily available at all reasonable times for inspection by the licensing authority or any person appointed by the sponsor to audit the arrangements for the trial.

(3) The master file shall at all times contain the essential documents relating to that clinical trial.

(4) The essential documents relating to a clinical trial are those which—

(a) enable both the conduct of the clinical trial and the quality of the data produced to be evaluated; and

(b) show whether the trial is, or has been, conducted in accordance with the relevant requirements of these Regulations.

(5) The essential documents shall contain information specific to each phase of the trial.

(6) The sponsor shall ensure that any alteration to a document contained, or which has been contained, in the trial master file shall be traceable.

(7) The sponsor and the chief investigator shall ensure that the documents contained, or which have been contained, in the trial master file are retained for at least 5 years after the conclusion of the trial and that during that period are—

(a) readily available to the licensing authority on request; and

(b) complete and legible.

(8) The sponsor and chief investigator shall ensure that the medical files of trial subjects are retained for at least 5 years after the conclusion of the trial.

(9) The sponsor shall appoint named individuals within his organisation to be responsible for archiving the documents which are, or have been, contained in the trial master file and, subject to paragraph (2), access to those documents shall be restricted to those appointed individuals.

(10) If there is transfer of ownership of data or documents connected with the clinical trial—

(a) the sponsor shall record the transfer; and

(b) the new owner shall be responsible for data retention and archiving in accordance with paragraphs (2), (7) and (8).

(11) For the purposes of this regulation, an individual is an individual within the sponsor’s organisation where—

(a) he is employed or engaged by the sponsor;

(b) he is acting under arrangements made with the sponsor for the purposes of managing or conducting the clinical trial;

(d) where the sponsor is a body of persons, he is—

(i) a member of the body, or

(ii) employed or engaged by such a member.

Principles based on Articles 2 to 5 of the GCP Directive

1

The rights, safety and well-being of the trial subjects shall prevail over the interests of science and society.

2

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The Medicines for Human Use (Clinical Trials) Regulations 2004

Hearing before the appropriate committee

Licensing authority decision

Right to be heard by a person appointed

Hearing before person appointed

4

Sponsor’s responsibility for the investigator’s brochure

3A