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

Amendment to regulation 29A

regulation 19 + 19.—(1) Regulation 29A (notification of serious breaches)(1) is amended as follows.

(2) In paragraph (1)(b)—

regulation 19 2 a + (a)for “amended” substitute “modified”;

regulation 19 2 b + (b)for “regulations 22 to 25” substitute “regulations 20 to 22C”.

(3) In paragraph (2)(a), for “subjects” substitute “participants”.