Guidance

MHRA phase I accreditation scheme

How to join the phase I accreditation scheme.

From:
Medicines and Healthcare products Regulatory Agency
Published
18 December 2014
Last updated
528 SeptemberNovember 2022 — See all updates

The MHRA phase I accreditation scheme is a voluntary scheme for organisations conducting phase I trials, in particular for those conducting first in human (FIH) trials.

The scheme aims to make sure trials are as safe as possible and to create public confidence in the regulation of phase I clinical trials.

Organisations in the scheme have to exceed the basic regulatory good clinical practice (GCP) standards by having additional procedures that include the highest standards for avoiding harm to trial subjects and for handling any medical emergencies.

Status of Phase 1 clinical trials in response to coronavirus (COVID-19).

Find out more about the phase I accreditation scheme requirements (PDF, 433 KB, 14 pages)

See guidance on the phase I accreditation scheme (PDF, 561 KB, 19 pages)

See the phase I accreditation scheme application form (MS Word Document, 526 KB)

See the phase I accreditation scheme compliance checklist (MS Excel Spreadsheet, 46.8 KB)

See the phase I accreditation scheme variation form (MS Word Document, 76.9 KB)

List of accredited phase I units (PDF, 282281 KB, 1 page)

Apply for the phase I accreditation scheme

Send the completed phase I accreditation scheme application form to phase1accreditationscheme@mhra.gov.uk.

Principal investigator in first-in-human (FIH) trials

To act as a principal investigator in a FIH trial, you must meet the requirements stated in the scheme.

However, if you do not have all the post graduate qualifications, but have extensive experience in conducting FIH trials, you may apply for an exemption to the scheme requirement.

This exemption is independently reviewed by Faculty of Pharmaceutical Medicine, who advise MHRA GCP inspectorate of their recommendation.

Procedure for advice by the FPM on suitability of applicants to serve as principal investigators for first-in-human studies (PDF, 420 KB, 2 pages)

Request for acceptance as a phase I principal investigator for first in human trials (MS Word Document, 95.5 KB)

Published 18 December 2014
Last updated 528 SeptemberNovember 2022 + show all updates

  1. Updated 'list of accredited phase I units'

  2. Administrative updates to branding, format and staff titles.

  3. Updated 'List of Accredited units'.

  4. Updated 'list of accredited Phase I units' PDF.

  5. Updated the List of accredited phase 1 units

  6. The list of of accredited units has been updated

  7. Updated list of accredited units

  8. Updated versions of the phase I accreditation scheme requirements, associated guidance and new forms including phase I accreditation compliance checklist and variation form released.

  9. Updated 'List of accredited phase I units' to 28 January version.

  10. Updated the list of accredited units

  11. Uploaded new version of List of accredited phase I units PDF.

  12. New list of accredited units (08 Jan 2020)

  13. New list of accredited units

  14. Minor changes to some text and the order in which the content is displayed.

  15. New version of the list of accredited phase I units has been uploaded

  16. Uploaded new version of List of accredited Phase 1 units update.

  17. Updated list of accredited phase I units.

  18. Updated list of Phase I accredited units

  19. Updated list of accredited phase I units.

  20. List of accredited phase I units updated.

  21. updated list of accredited units

  22. List of Accredited Phase I Units updated.

  23. updated List of accredited phase I units

  24. Updated list of accredited phase I units.

  25. Updated list List of accredited phase I units

  26. A new version of the voluntary Phase I Accreditation Scheme and supporting guidance have been released to allow the integration of the accreditation scheme into the good clinical practice risk-based inspection programme.

  27. Updated list of accredited units

  28. The list of accredited phase I units has been updated.

  29. First published.