{
  "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-II/division-E/division-7",
  "json_url": "https://openlegislation.uk/eu-regulation-2014-536/annex-II/division-E/division-7.json",
  "legislation": "eur/2014/536",
  "legislation_title": "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)",
  "legislation_url": "https://openlegislation.uk/eu-regulation-2014-536",
  "path": "annex/II/division/E/division/7",
  "kind": "division",
  "number": "7",
  "heading": "Where applicable, additional supporting information shall at least include:",
  "text": "(a) summaries of data;\n(b) an updated overall risk/benefit assessment;\n(c) possible consequences for subjects already included in the clinical trial;\n(d) possible consequences for the evaluation of the results;\n(e) documents which relate to any changes to the information provided to subjects or their legally designated representatives, the informed consent procedure, informed consent forms, information sheets, or to letters of invitation; and\n(f) a justification for the changes sought in the application for a substantial modification.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eur/2014/536/annex/II/division/E/division/7",
    "retrieved_at": "2026-11-01T14:47:39.363123+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."
}