# 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

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

Unblinded information shall be accessible only to persons who need to be involved in the safety reporting to the Agency, to Data Safety Monitoring Boards (’DSMB’), or to persons performing ongoing safety evaluations during the clinical trial.

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Source: https://www.legislation.gov.uk/eur/2014/536/annex/III/division/2/division/2.5/division/20 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-III/division-2/division-2.5/division-20
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.