Regulation 21 Amendment to regulation 31I1

United Kingdom As made

(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)^f1—

(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”.

Annotations