United Kingdom Statutory Instruments

(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.".

(i) after "include" insert " minors or", and

(ii) for "Part 5" substitute "Part 4 or Part 5 respectively".

(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.".

(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 applicable requirements of Directive 2001/83/EC, the Directive, the GCP Directive and Commission Directive 2003/94/EC.

    (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;

(c) where the sponsor is an individual, he is the sponsor; or

(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.".

" (bb) in the case of an authorisation relating to the inactivation of viral or non-conventional agents, the manufacturing process; and".

(a) comply with the principles and guidelines of good manufacturing practice;

(b) comply with the provisions referred to in regulation 40(3);

(c) allow the licensing authority access to his premises at any reasonable time; and

(d) put and keep in place arrangements which enable the qualified person to carry out his duties, including placing at his disposal all the necessary facilities.".

(i) substitute "change—" for "change the—"

(ii) after head (ii), insert the following head—


" (iia) the manufacturing process,",



(iii) in head (iv), after "facilities,", insert "or", and

(iv) after head (iv), insert the following head—



" (v) the staff, including the qualified person,"; and

(b) for paragraph (8), substitute the following paragraph—

" (a) regulation 3A;";

(c) after sub-paragraph (e), insert the following sub-paragraph—

" (ee) regulation 29A;"; and

(d) after sub-paragraph (f), insert the following sub-paragraph—

" (ff) regulation 31A(1) to (3) and (5) to (10);".

(i) in sub-paragraph (b), omit "or",

(ii) in sub-paragraph (c), for "the Authority;" substitute "the Authority, or",

(iii) after sub-paragraph (c), insert the following sub-paragraph—

" (d) in relation to the Gene Therapy Advisory Committee, the Secretary of State;";

(b) in paragraph 6 (committees, meetings and proceedings), after sub-paragraph (4), insert—

(a) where the trial proceeds, at least three years from the conclusion of the trial; or

(b) where the trial does not proceed, at least three years from the date of the opinion."; and

(c) in paragraph 8 (deputies and co-opted members), in sub-paragraph (6), for "(4)" substitute "(5)".

(i) in paragraph 1, in sub-paragraph (b), for "the European Community" substitute "an EEA State", and

(ii) in paragraph 2, in sub-paragraph (b), for "the number" substitute "any number"; and

(c) in Part 4 (notification of conclusion of a clinical trial)—

(i) in paragraph 1, in sub-paragraph (b), for "the European Community" substitute "an EEA State", and

(ii) in paragraph 2, in sub-paragraph (b), for "the number" substitute "any number".

(i) in head (d), for "(6)" substitute "(5)", and

(ii) in head (f)—


(aa) omit "on a review", and

(bb) for "(5)" substitute "(6)"; and

(c) in paragraph 5, for "11" substitute "12".

(i) in sub-paragraph (2), in head (b), for "(3)" substitute "(4)",

(ii) in sub-paragraph (6), after "opinion in relation" insert " to", and

(iii) in sub-paragraph (7), for "(a)" substitute "(b)"; and

(b) in paragraph 6, in sub-paragraph (1), in head (a), after "conducted" insert "after".