{
  "url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-12A/paragraph-31",
  "json_url": "https://openlegislation.uk/human-medicines-regulations-2012/schedule-12A/paragraph-31.json",
  "legislation": "uksi/2012/1916",
  "legislation_title": "The Human Medicines Regulations 2012",
  "legislation_url": "https://openlegislation.uk/human-medicines-regulations-2012",
  "path": "schedule/12A/paragraph/31",
  "kind": "paragraph",
  "number": "31",
  "heading": "Format of the abstract of the final study report",
  "text": "The abstract of the final study report for a non-interventional post-authorisation safety studies must be submitted in the following format—\n(a) title, with subtitles including date of the abstract and name and affiliation of main author;\n(b) keywords (not more than five keywords indicating the main study characteristics);\n(c) rationale and background;\n(d) research question and objectives;\n(e) study design;\n(f) setting;\n(g) subjects and study size, including dropouts;\n(h) variables and data sources;\n(i) results;\n(j) discussion (including, where relevant, an evaluation of the impact of study results on the risk–benefit balance of the product);\n(k) name of holder; and\n(l) names and affiliations of principal investigators.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Sch. 12A inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), reg. 1, Sch. 6 (as amended by S.I. 2019/1385, reg. 1, Sch. 1 para. 9 and S.I. 2020/1488, reg. 1, Sch. 2 para. 192); 2020 c. 1, Sch. 5 para. 1(1)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2012/1916/schedule/12A/paragraph/31",
    "retrieved_at": "2026-10-29T01:24:34.993203+00:00"
  },
  "licence": "Open Government Licence v3.0",
  "licence_url": "https://www.nationalarchives.gov.uk/doc/open-government-licence/version/3/",
  "attribution": "Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives."
}