ANNEX V

The summary of the results of the clinical trial for laypersons shall contain information on the following elements: Clinical trial identification (including title of the trial, protocol number, EU trial number and other identifiers); Name and contact details of the sponsor; General information about the clinical trial (including where and when the trial was conducted, the main objectives of the trial and an explanation of the reasons for conducting it); Population of subjects (including information on the number of subjects included in the trial in the Member State concerned, in the Union and in third countries; age group breakdown and gender breakdown; inclusion and exclusion criteria); Investigational medicinal products used; Description of adverse reactions and their frequency; Overall results of the clinical trial; Comments on the outcome of the clinical trial; Indication if follow up clinical trials are foreseen; Indication where additional information could be found.

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.