{
  "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-D/division-15",
  "json_url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-D/division-15.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/I/division/D/division/15",
  "kind": "division",
  "number": "15",
  "heading": "The protocol shall be identified by:",
  "text": "(a) the title of the clinical trial;\n(b) the EU trial number;\n(c) the sponsor's protocol code number specific for all versions of it (if relevant);\n(d) the date and number of the version, to be updated when it is amended;\n(e) a short title or name assigned to the protocol; and\n(f) the name and address of the sponsor, as well as the name and function of the representative or representatives of the sponsor authorised to sign the protocol or any substantial modification to the protocol.",
  "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/I/division/D/division/15",
    "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."
}