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24. The registered person shall ensure that –
(a)before any research involving patients, information about patients is undertaken in or for the purposes of the establishment or agency, a research proposal is prepared and approval is obtained from the appropriate Ethics Committee;
(b)any clinical trial to be conducted in the establishment or agency has been authorised in accordance with the Medicines for Human Use (Clinical Trials) Regulations 2004(1).
S.I. 2004/1031
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