{
  "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-V",
  "json_url": "https://openlegislation.uk/eu-regulation-2014-536/annex-V.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/V",
  "kind": "annex",
  "number": "V",
  "heading": "CONTENT OF THE SUMMARY OF THE RESULTS OF THE CLINICAL TRIAL FOR LAYPERSONS",
  "text": "The summary of the results of the clinical trial for laypersons shall contain information on the following elements:\n1.. Clinical trial identification (including title of the trial, protocol number, EU trial number and other identifiers);\n2.. Name and contact details of the sponsor;\n3.. General information about the clinical trial (including where and when the trial was conducted, the main objectives of the trial and an explanation of the reasons for conducting it);\n4.. Population of subjects (including information on the number of subjects included in the trial in the Member State concerned, in the Union and in third countries; age group breakdown and gender breakdown; inclusion and exclusion criteria);\n5.. Investigational medicinal products used;\n6.. Description of adverse reactions and their frequency;\n7.. Overall results of the clinical trial;\n8.. Comments on the outcome of the clinical trial;\n9.. Indication if follow up clinical trials are foreseen;\n10.. Indication where additional information could be found.",
  "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/V",
    "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."
}