GovWire

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, 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, 281 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)