# 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), Division 10: The information shall at least include:

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

(a) a valid EU trial number;
(b) a sponsor study number;
(c) an identifiable coded subject;
(d) an identifiable reporter;
(e) a SUSAR;
(f) a suspect investigational medicinal product (including active substance name-code);
(g) a causality assessment.

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Source: https://www.legislation.gov.uk/eur/2014/536/annex/III/division/2/division/2.3/division/10 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-III/division-2/division-2.3/division-10
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.