Regulation 17 Amendment to regulation 28

(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^f1.

(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)—

(a)

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

(b)

for “sites”, in both places where it occurs, substitute “locations”.

Annotations

Footnotes

f1: The Guideline can be found at https://ich.org/page/efficacy-guidelines. A printed version of the document can be made available on request by the Department of Health and Social Care, 39 Victoria Street, London SW1H 0EU.