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

Amendment to regulation 28

regulation 17 + 17.—(1) Regulation 28 (good clinical practice and protection of clinical trial subjects) is amended as follows.

(2) In the heading, for “subjects” substitute “participants”.

(3) After paragraph (1) insert—

“(1A) The conditions and principles of good clinical practice include those in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice, as amended from time to time(1).

(1B) For the avoidance of doubt—

(a)the functions of the sponsor include functions in relation to—

(i)the development and maintenance of trial specific computerised systems, and

(ii)the selection and oversight of a laboratory in relation to the analysis or evaluation of human samples collected as part of the clinical trial; and

(b)conducting a trial includes the analysis or evaluation of human samples collected as part of the clinical trial.”.

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

(5) In paragraph (4), for “subject” substitute “participant”.

(6) In paragraph (5)—

regulation 17 6 a + (a)for “site”, in both places where it occurs, substitute “location”;

regulation 17 6 b + (b)for “sites”, in both places where it occurs, substitute “locations”.