Guidance

MHRA phase I accreditation scheme

How to join the phase I accreditation scheme.

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.

Find out more about the phase I accreditation scheme requirements (PDF, 111KB, 12 pages)

See guidance on the phase I accreditation scheme (PDF, 143KB, 16 pages)

See the phase I accreditation scheme application form (MS Word Document, 764KB)

Apply for the phase I accreditation scheme

Send the completed Procedure for advice by the FPM on suitability of applicants to serve as principal investigators for first-in-human studies (PDF, 71.8KB, 2 pages) 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.

Request for acceptance as a phase I principal investigator for first in human trials (MS Word Document, 231KB)

List of accredited phase I units (PDF, 112KB, 1 page)

Published 18 December 2014
Last updated 20 October 2017 + show all updates
  1. Updated list of accredited phase I units.
  2. Updated list of Phase I accredited units
  3. Updated list of accredited phase I units.
  4. List of accredited phase I units updated.
  5. updated list of accredited units
  6. List of Accredited Phase I Units updated.
  7. updated List of accredited phase I units
  8. Updated list of accredited phase I units.
  9. Updated list List of accredited phase I units
  10. 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.
  11. Updated list of accredited units
  12. The list of accredited phase I units has been updated.
  13. First published.