Part 5Amendment to Part 4 (Good Clinical Practice and the Conduct of Clinical Trials)

Amendment to regulation 31A

regulation 22 + 22.—(1) Regulation 31A (trial master file and archiving) is amended as follows.

(2) In paragraph (7)—

regulation 22 2 a + (a)at the beginning, insert “Subject to paragraph (7A),”;

regulation 22 2 b + (b)after “master file” insert “(including documents contained in electronic form)”;

regulation 22 2 c + (c)for “5 years” substitute “the period of 25 years beginning with the day”.

(3) After paragraph (7) insert—

“(7A) If, at the date of the expiry of the 25 years referred to in paragraph (7), the data generated by the trial is being used to support an application for a UK marketing authorization, the sponsor shall ensure the documents referred to in paragraph (7) are retained for at least the period of 2 years beginning with the day after the grant of that UK marketing authorization.”.

(4) In paragraph (8)—

regulation 22 4 a + (a)for “subjects” substitute “participants”;

regulation 22 4 b + (b)for “5 years after conclusion of the trial” substitute “the period of 25 years beginning with the day after conclusion of the trial, or such period as is required by any other enactment, if longer”.