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

Amendment to regulation 31

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

(2) In paragraph (1)—

(a)after “clinical trial” insert “or part of a clinical trial”;

(b)in sub-paragraph (a)(ii)(1)—

(i)omit “by the licensing authority”;

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

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

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

(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)—

(a)in sub-paragraph (a), for “sites” substitute “locations”;

(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”;

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

(5) In paragraph (5)—

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

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

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