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4.—(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”.
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