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

Amendment to regulation 31

regulation 21 + 21.—(1) Regulation 31 (suspension or termination of clinical trial) is amended as follows.

(2) In paragraph (1)—

regulation 21 2 a + (a)after “clinical trial” insert “or part of a clinical trial”;

regulation 21 2 b + (b)in sub-paragraph (a)(ii)(1)—

regulation 21 2 b i + (i)omit “by the licensing authority”;

regulation 21 2 b ii + (ii)for “regulation 18(2) or (6), 19(8), 20(5), 24(5)” substitute “regulation 18(3), 18B(3), 22A(4), 22C(3)”;

regulation 21 2 c + (c)in the words after sub-paragraph (a)(ii), for “site); or” substitute “location);”;

regulation 21 2 d + (d)in sub-paragraph (b), for “site,” substitute “location; or”;

regulation 21 2 e + (e)after sub-paragraph (b), insert—

“(c)the trial has lapsed in accordance with regulation 26 and the sponsor has not notified the licensing authority that the trial has ended,”.

(3) In paragraph (2), for “trial site”, in each place where it occurs, substitute “trial location”.

(4) In paragraph (3)—

regulation 21 4 a + (a)in sub-paragraph (a), for “sites” substitute “locations”;

regulation 21 4 b + (b)in sub-paragraph (b), after “the trial” insert “in whole or in part, and, if it applies to part of the trial, to which part it applies”;

regulation 21 4 c + (c)in sub-paragraph (c)(ii), for “site” substitute “location”.

(5) In paragraph (5)—

regulation 21 5 a + (a)for “site”, in both places where it occurs, substitute “location”;

regulation 21 5 b + (b)in sub-paragraph (a), after “terminating the trial” insert “(in whole or in part)”.

(6) In paragraph (6), for “subjects” substitute “participants”.