{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2006/regulation-4",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2006/regulation-4.json",
  "legislation": "uksi/2006/1928",
  "legislation_title": "The Medicines for Human Use (Clinical Trials) Amendment Regulations 2006",
  "legislation_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-amendment-regulations-2006",
  "path": "regulation/4",
  "kind": "regulation",
  "number": "4",
  "heading": "Insertion of regulation 3A of the principal Regulations",
  "text": "After regulation 3 of the principal Regulations (sponsor of a clinical trial) insert the following regulation—\n“Sponsor’s responsibility for the investigator’s brochure\n3A The sponsor of a clinical trial shall—\n(a) ensure that the investigator’s brochure for that trial, and any update of that brochure, presents the information it contains in a concise, simple, objective, balanced and non-promotional form that enables a clinician or potential investigator to understand it and make an unbiased risk-benefit assessment of the appropriateness of the proposed clinical trial; and\n(b) validate and update the investigator’s brochure at least once a year.”.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2006/1928/regulation/4",
    "retrieved_at": "2026-10-29T04:25:32.359836+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."
}