# The Human Medicines Regulations 2012, Paragraph 31: Format of the abstract of the final study report


The abstract of the final study report for a non-interventional post-authorisation safety studies must be submitted in the following format—
(a) title, with subtitles including date of the abstract and name and affiliation of main author;
(b) keywords (not more than five keywords indicating the main study characteristics);
(c) rationale and background;
(d) research question and objectives;
(e) study design;
(f) setting;
(g) subjects and study size, including dropouts;
(h) variables and data sources;
(i) results;
(j) discussion (including, where relevant, an evaluation of the impact of study results on the risk–benefit balance of the product);
(k) name of holder; and
(l) names and affiliations of principal investigators.

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Source: https://www.legislation.gov.uk/uksi/2012/1916/schedule/12A/paragraph/31 (the official version)
Page: https://openlegislation.uk/human-medicines-regulations-2012/schedule-12A/paragraph-31
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.