Original document : https://www.gov.uk/guidance/mhra-phase-i-accreditation-scheme

Change description : 2025-04-08 14:07:00: Added updated versions of:phase I accreditation scheme requirementsguidance on the phase I accreditation schemelist of accredited phase I units [Guidance and regulation]

Showing diff : 2025-01-24 15:44:39.902000470 +00:00..2025-04-08 13:07:40.263915575 +00:00

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
248 JanuaryApril 2025 — 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, 433189 KB, 14 pages)

See guidance on the phase I accreditation scheme (PDF, 561277 KB, 1920 pages)

See the List of accredited phase I units (PDF, 28683.8 KB, 1 page)

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

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

Apply for the phase I accreditation scheme

Send the completed phase I accreditation scheme compliance checklist 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, 100 KB)

List of accredited phase I units (PDF, 28683.8 KB, 1 page)

Updates to this page

Published 18 December 2014

Last updated 248 JanuaryApril 2025 + show href="#full-history">+ show all updates

    3. Updated list of accredited Phase I units

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Contents

Update history

2025-04-08 14:07
Added updated versions of:phase I accreditation scheme requirementsguidance on the phase I accreditation schemelist of accredited phase I units

2025-01-24 15:43
Updated list of accredited Phase I units

2024-10-31 14:32
Updated ‘Request for acceptance as a phase I principal investigator for first in human trials’ document.

2023-11-10 14:56
Updated List of accredited phase I units

2023-10-25 11:50
Added List of Accredited Units 24 October 2023

2023-07-10 14:15
List of accredited phase I units updated (up to 10 July 2023)

2023-03-15 11:54
List of accredited phase I units PDF replaced with new version

2023-03-08 09:15
Updated ‘List of accredited units-27 February 2023’

2023-02-03 17:13
Updated ‘list of accredited units’ as of 1 Feb 23

2022-11-28 10:31
Updated ‘list of accredited phase I units’

2022-09-05 17:24
Administrative updates to branding, format and staff titles.

2022-07-27 12:09
Updated ‘List of Accredited units’.

2022-07-07 14:09
Updated ‘list of accredited Phase I units’ PDF.

2022-05-25 14:02
Updated the List of accredited phase 1 units

2022-03-30 16:17
The list of of accredited units has been updated