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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 · European Union

a description of the statistical methods to be employed, including, if relevant: timing of any planned interim analysis and the number of subjects planned to be enrolled; reasons for choice of sample size; calculations of the power of the clinical trial and clinical relevance; the level of significance to be used; criteria for the termination of the clinical trial; procedures for accounting for missing, unused, and spurious data and for reporting any deviation from the original statistical plan; and the selection of subjects to be included in the analyses;

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Source: EUR-Lex (Cellar) · retrieved 2026-11-06 · Text as adopted (Official Journal); later amendments are not incorporated in this text.