# 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 20: The protocol shall describe the procedures for:

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

(a) eliciting and recording adverse events by the investigator, and the reporting of relevant adverse events by the investigator to the sponsor;
(b) reporting by the investigator to the sponsor of those serious adverse events which have been identified in the protocol as not requiring immediate reporting;
(c) reporting of suspected unexpected serious adverse reactions by the sponsor to the Eudravigilance database; and
(d) follow-up of subjects after adverse reactions including the type and duration of follow-up.

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Source: https://www.legislation.gov.uk/eur/2014/536/annex/I/division/D/division/20 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-D/division-20
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.