{
  "url": "https://openlegislation.uk/good-laboratory-practice-regulations-1997/schedule-2/paragraph-13",
  "json_url": "https://openlegislation.uk/good-laboratory-practice-regulations-1997/schedule-2/paragraph-13.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/13",
  "kind": "paragraph",
  "number": "13",
  "heading": "Performance of the study",
  "text": "(1) Purpose: To verify that written study plans exist and that the plans and the conduct of the study are in accordance with good laboratory practice principles.\n(2) The inspectors should check that—\nthe study plan was signed by the study director,\nany amendments to the study plan were signed and dated,\nthe date of the agreement to the study plan by the sponsor was recorded (where applicable),\nmeasurements, observations and examinations were in accordance with the study plan and relevant standard operating procedures,\nthe results of these measurements, observations and examinations were recorded directly, promptly, accurately and legibly and were signed (or initialled) and dated,\nany changes in the raw data, including data stored in computers, did not obscure previous entries, included the reason for the change and were signed and dated,\ncomputer-generated or stored data have been identified and that the procedures to protect them against unauthorised amendments or loss are adequate,\nthe computer software used within the study is reliable, accurate, and can be validated,\nany unforeseen events recorded in the raw data have been investigated and evaluated,\nthe results presented in the reports of the study (interim or final) are consistent and complete and that they correctly reflect the raw data.",
  "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/13",
    "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."
}