# Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (Text with EEA relevance), Division 4

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

Abstract: stand-alone summary of the study protocol, including the following subsections:
(a)title with subtitles including version and date of the protocol and name and affiliation of the main author;
(b)rationale and background;
(c)research question and objectives;
(d)study design;
(e)population;
(f)variables;
(g)data sources;
(h)study size;
(i)data analysis;
(j)milestones.

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Source: https://www.legislation.gov.uk/eur/2012/520/annex/III/division/1/division/4 (the official version)
Page: https://openlegislation.uk/eu-regulation-2012-520/annex-III/division-1/division-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.