# 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 26

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

The purpose of the IB is to provide the investigators and others involved in the clinical trial with information to facilitate their understanding of the rationale for, and their compliance with, key features of the protocol, such as the dose, dose frequency/interval, methods of administration, and safety monitoring procedures.

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Source: https://www.legislation.gov.uk/eur/2014/536/annex/I/division/E/division/26 (the official version)
Page: https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-E/division-26
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.