{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025/regulation-5",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025/regulation-5.json",
  "legislation": "uksi/2025/538",
  "legislation_title": "The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025",
  "legislation_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2025",
  "path": "regulation/5",
  "kind": "regulation",
  "number": "5",
  "heading": "Insertion of new regulation 3B",
  "text": "After regulation 3A (sponsor’s responsibility for the investigator’s brochure) insert—\n“Investigator in a clinical trial\n3B The investigator, in relation to a clinical trial, shall be a health care professional who is appropriately trained to undertake that role in a clinical trial.”.",
  "extent": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "I",
      "label": "I1",
      "text": "Reg. 5 in force at 28.4.2026, see reg. 1(2)"
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2025/538/regulation/5",
    "retrieved_at": "2026-10-28T21:16:31.731081+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."
}