{
  "url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-28",
  "json_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004/regulation-28.json",
  "legislation": "uksi/2004/1031",
  "legislation_title": "The Medicines for Human Use (Clinical Trials) Regulations 2004",
  "legislation_url": "https://openlegislation.uk/medicines-for-human-use-clinical-trials-regulations-2004",
  "path": "regulation/28",
  "kind": "regulation",
  "number": "28",
  "heading": "Good clinical practice and protection of clinical trial participants",
  "text": "(1) No person shall—\n(a) conduct a clinical trial; or\n(b) perform the functions of the sponsor of a clinical trial (whether that person is the sponsor or is acting under arrangements made with that sponsor),\notherwise than in accordance with the conditions and principles of good clinical practice.\n(1A) The conditions and principles of good clinical practice include those in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use Guideline for Good Clinical Practice, as amended from time to time.\n(1B) For the avoidance of doubt—\n(a) the functions of the sponsor include functions in relation to—\n(i) the development and maintenance of trial specific computerised systems, and\n(ii) the selection and oversight of a laboratory in relation to the analysis or evaluation of human samples collected as part of the clinical trial; and\n(b) conducting a trial includes the analysis or evaluation of human samples collected as part of the clinical trial.\n(2) Subject to paragraph (5), the sponsor of a clinical trial shall put and keep in place arrangements for the purpose of ensuring that with regard to that trial the conditions and principles of good clinical practice are satisfied or adhered to.\n(3) Subject to paragraphs (4) and (5), the sponsor of a clinical trial shall ensure that—\n(a) the investigational medicinal products used in the trial, and\n(b) any devices used for the administration of such products,\nare made available to the participants of the trial free of charge.\n(4) The restriction in paragraph (3) shall not apply in relation to any charge payable by a participant under regulations made under—\n(a) the National Health Service Act 1977 ;\n(b) the National Health Service (Scotland) Act 1978 ; or\n(c) the Health and Personal Social Services (Northern Ireland) Order 1972 ,\nin respect of any medicinal products or devices provided in pursuance of those Acts or that Order.\n(5) If—\n(a) a clinical trial is conducted at more than one trial location; and\n(b) the request for authorisation to conduct that trial specifies that in relation to one or more trial locations the duties of the sponsor under paragraphs (2) and (3) are to be performed by a person other than the sponsor,\nthose duties shall, in relation to that location or those locations, be performed by the person so specified.",
  "extent": null,
  "status": null,
  "version": "current",
  "annotations": [
    {
      "type": "F",
      "label": "F1",
      "text": "Reg. 28(1A)(1B) inserted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 17(3)"
    },
    {
      "type": "F",
      "label": "F2",
      "text": "Word in reg. 28(3) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 17(4)"
    },
    {
      "type": "F",
      "label": "F3",
      "text": "Word in reg. 28(4) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 17(5)"
    },
    {
      "type": "F",
      "label": "F4",
      "text": "Word in reg. 28(5) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 17(6)(a)"
    },
    {
      "type": "F",
      "label": "F5",
      "text": "Word in reg. 28(5) substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 17(6)(b)"
    },
    {
      "type": "F",
      "label": "F6",
      "text": "Word in reg. 28 heading substituted (28.4.2026) by The Medicines for Human Use (Clinical Trials) (Amendment) Regulations 2025 (S.I. 2025/538), regs. 1(2), 17(2)"
    },
    {
      "type": "M",
      "label": "M1",
      "text": "1977 c. 49."
    },
    {
      "type": "M",
      "label": "M2",
      "text": "1978 c. 29."
    },
    {
      "type": "M",
      "label": "M3",
      "text": "S.I. 1972/1265 (N.I. 14)."
    }
  ],
  "outstanding_effects": [],
  "provenance": {
    "source": "legislation.gov.uk",
    "source_url": "https://www.legislation.gov.uk/uksi/2004/1031/regulation/28",
    "retrieved_at": "2026-10-29T05:28:03.775386+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."
}