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inspection

as defined in Regulation (EU) No 536/2014 of the European Parliament and of the Council of…, Article 2(2), point (31) (Definitions)

(31) 

‘Inspection’ means the act by a competent authority of conducting an official review of documents, facilities, records, quality assurance arrangements, and any other resources that are deemed by the competent authority to be related to the clinical trial and that may be located at the clinical trial site, at the sponsor's and/or contract research organisation's facilities, or at other establishments which the competent authority sees fit to inspect;

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