# 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), Article 56: Recording, processing, handling and storage of information

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

1. All clinical trial information shall be recorded, processed, handled, and stored by the sponsor or investigator, as applicable, in such a way that it can be accurately reported, interpreted and verified while the confidentiality of records and the personal data of the subjects remain protected in accordance with the applicable law on personal data protection.
2. Appropriate technical and organisational measures shall be implemented to protect information and personal data processed against unauthorised or unlawful access, disclosure, dissemination, alteration, or destruction or accidental loss, in particular where the processing involves the transmission over a network.

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Source: https://www.legislation.gov.uk/eur/2014/536/article/56 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/article-56
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.