# 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 21

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

However, for clinial trials carried out in high morbidity or high mortality disease, where efficacy end-points could also be SUSARs or when mortality or another ’serious’ outcome, that may potentially be reported as a SUSAR, is the efficacy end-point in a clinical trial, the integrity of the clinical trial may be compromised if the blind is systematically broken. Under these and similar circumstances, the sponsor shall highlight in the protocol which serious events are to be treated as disease-related and are not subject to systematic unblinding and expedited reporting.

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Source: https://www.legislation.gov.uk/eur/2014/536/annex/III/division/2/division/2.5/division/21 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-III/division-2/division-2.5/division-21
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.