{
  "url": "https://openlegislation.uk/good-laboratory-practice-regulations-1997/schedule-2/paragraph-16",
  "json_url": "https://openlegislation.uk/good-laboratory-practice-regulations-1997/schedule-2/paragraph-16.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/2/paragraph/16",
  "kind": "paragraph",
  "number": "16",
  "heading": null,
  "text": "Laboratory inspections will generally include inter alia(limited) study audits. These may be brief reviews of on-going or completed studies. When specific study audits are requested by regulatory authorities, the conduct and reporting of the study should be subjected to a detailed examination. Because of the wide variation in the types of studies which might be audited, only general guidance is appropriate, and inspectors and others taking part in study audits will always need to exercise judgment as to the nature and extent of their examinations. The objective should be to reconstruct the study from the study plan using relevant standard operating procedures, raw data and other archived material.",
  "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/2/paragraph/16",
    "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."
}