{
  "url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-D/division-19",
  "json_url": "https://openlegislation.uk/eu-regulation-2014-536/annex-I/division-D/division-19.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/19",
  "kind": "division",
  "number": "19",
  "heading": "With regard to the notification of adverse events, the protocol shall identify the categories of:",
  "text": "(a) adverse events or laboratory anomalies that are critical to safety evaluations and must be reported by the investigator to the sponsor, and\n(b) serious adverse events which do not require immediate reporting by the investigator to the sponsor.",
  "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/19",
    "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."
}