{
  "url": "https://openlegislation.uk/eu-directive-2004-9/annex-I/part-B/division-16",
  "json_url": "https://openlegislation.uk/eu-directive-2004-9/annex-I/part-B/division-16.json",
  "legislation": "eudr/2004/9",
  "legislation_title": "Directive 2004/9/EC of the European Parliament and of the Council of 11 February 2004 on the inspection and verification of good laboratory practice (GLP) (Codified version) (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2004-9",
  "path": "annex/I/part/B/division/16",
  "kind": "division",
  "number": null,
  "heading": "Performance of the study",
  "text": "Purpose: to verify that written study plans exist and that the plans and the conduct of the study are in accordance with GLP principles.\nThe inspector should check that:\nthe study plan was signed by the study director,\nany amendments to the study plan were signed and dated by the study director,\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 SOPs,\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 identified the person responsible for the change and the date it was made,\ncomputer-generated or stored data have been identified and that the procedures to protect them against unauthorised amendments or loss are adequate,\nthe computerised systems used within the study are reliable, accurate and have been 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": "E+W+S+N.I.",
  "status": null,
  "version": "current",
  "annotations": [],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/eudr/2004/9/annex/I/part/B/division/16",
    "retrieved_at": "2026-11-01T15:22:51.196773+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."
}