# Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (Text with EEA relevance), Annex V: CONTENT OF THE SUMMARY OF THE RESULTS OF THE CLINICAL TRIAL FOR LAYPERSONS

Extent: E+W+S+N.I.

The summary of the results of the clinical trial for laypersons shall contain information on the following elements:
1.. Clinical trial identification (including title of the trial, protocol number, EU trial number and other identifiers);
2.. Name and contact details of the sponsor;
3.. 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);
4.. 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);
5.. Investigational medicinal products used;
6.. Description of adverse reactions and their frequency;
7.. Overall results of the clinical trial;
8.. Comments on the outcome of the clinical trial;
9.. Indication if follow up clinical trials are foreseen;
10.. Indication where additional information could be found.

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Source: https://www.legislation.gov.uk/eur/2014/536/annex/V (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-V
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.