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2. In regulation 2(1) (interpretation) of the Medicines for Human Use (Clinical Trials) Regulations 2004(1)—
(a)for the definition “electronic signature”, substitute—
““electronic signature” means data in electronic form which is attached to or logically associated with other data in electronic form and which is used by the signatory to sign; ”; and
(b)after the definition of “serious adverse event”, insert—
““signatory” means a natural person who creates an electronic signature;”.
S.I. 2004/1031, to which there are amendments not relevant to these Regulations.
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