clinical study report
as defined in Regulation (EU) No 536/2014 of the European Parliament and of the Council of…, Article 2(2), point (35) (Definitions)
(35)
‘Clinical study report’ means a report on the clinical trial presented in an easily searchable format, prepared in accordance with Annex I, Part I, Module 5 of Directive 2001/83/EC and accompanying an application for marketing authorisation.