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inspection

as defined in Directive 2001/20/EC of the European Parliament and of the Council of 4 April…, Article 2, point (l) (Definitions)

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 site of the trial, 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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