Amendment of Schedule 1 to the Clinical Trials Regulations4
1
In Schedule 1 to the Clinical Trials Regulations (conditions and principles of good clinical practice and for the protection of clinical trial subjects), in Part 1 (application and interpretation), paragraph 1 shall be amended as follows.
2
In sub-paragraph (3), for “If” substitute “Subject to sub-paragraphs (6) and (7), if”.
3
In sub-paragraph (6)—
a
after “a subject who is” insert “a minor or”; and
b
for “Part 5” substitute “Part 4 in the case of a minor or paragraphs 1 to 5 of Part 5 in the case of an incapacitated adult”.
4
In sub-paragraph (7), for “Part 5” substitute “Part 4 in the case of a minor or paragraphs 1 to 5 of Part 5 in the case of an incapacitated adult”.