# 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 9

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

Research methods: description of the research methods, including:
(a)study design;
(b)setting: study population defined in terms of persons, place, time period, and selection criteria, including the rationale for any inclusion and exclusion criteria. Where any sampling from a source population is undertaken, a description of the source population and details of sampling methods shall be provided. Where the study design is a systematic review or a meta-analysis, the criteria for the selection and eligibility of studies shall be explained;
(c)variables;
(d)data sources: strategies and data sources for determining exposures, outcomes and all other variables relevant to the study objectives. Where the study will use an existing data source, such as electronic health records, any information on the validity of the recording and coding of the data shall be reported. In the case of a systematic review or meta-analysis, the search strategy and processes and any methods for confirming data from investigators shall be described;
(e)study size: any projected study size, precision sought for study estimates and any calculation of the study size that can minimally detect a pre-specified risk with a pre-specified interpretative power;
(f)data management;
(g)data analysis;
(h)quality control;
(i)limitations of the research methods.

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Source: https://www.legislation.gov.uk/eur/2012/520/annex/III/division/1/division/9 (the official version)
Page: https://openlegislation.uk/eu-regulation-2012-520/annex-III/division-1/division-9
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.