{
  "url": "https://openlegislation.uk/eu-directive-2005-28/article-16",
  "json_url": "https://openlegislation.uk/eu-directive-2005-28/article-16.json",
  "legislation": "eudr/2005/28",
  "legislation_title": "Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (Text with EEA relevance)",
  "legislation_url": "https://openlegislation.uk/eu-directive-2005-28",
  "path": "article/16",
  "kind": "article",
  "number": "16",
  "heading": null,
  "text": "The documentation referred to Article 15(5) of Directive 2001/20/EC as the trial master file shall consist of essential documents, which enable both the conduct of a clinical trial and the quality of the data produced to be evaluated. Those documents shall show whether the investigator and the sponsor have complied with the principles and guidelines of good clinical practice and with the applicable requirements and, in particular, with Annex I to Directive 2001/83/EC.\nThe trial master file shall provide the basis for the audit by the sponsor’s independent auditor and for the inspection by the competent authority.\nThe content of the essential documents shall be in accordance with the specificities of each phase of the clinical trial.\nThe Commission shall publish additional guidance in order to specify the content of these documents.",
  "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/2005/28/article/16",
    "retrieved_at": "2026-11-01T15:22:43.940499+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."
}