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

Amendment to regulation 29A

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

(2) In paragraph (1)(b)—

(a)for “amended” substitute “modified”;

(b)for “regulations 22 to 25” substitute “regulations 20 to 22C”.

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

(1)

Regulation 29A was inserted by S.I. 2006/1928.