{
  "url": "https://openlegislation.uk/good-laboratory-practice-regulations-1997/schedule-1/paragraph-20",
  "json_url": "https://openlegislation.uk/good-laboratory-practice-regulations-1997/schedule-1/paragraph-20.json",
  "legislation": "uksi/1997/654",
  "legislation_title": "The Good Laboratory Practice Regulations 1997",
  "legislation_url": "https://openlegislation.uk/good-laboratory-practice-regulations-1997",
  "path": "schedule/1/paragraph/20",
  "kind": "paragraph",
  "number": "20",
  "heading": "Study plan",
  "text": "(1) For each safety study, a plan should exist in a written form prior to initiation of the study.\n(2) The study plan should be retained as raw data.\n(3) All changes, modifications, or revisions of the study plan, as agreed to by the study director, including justifications, should be documented, signed and dated by the study director, and maintained with the study plan.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/1997/654/schedule/1/paragraph/20",
    "retrieved_at": "2026-10-29T12:22:49.085052+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."
}