# Clinical trials for medicines: MHRA phase I accreditation scheme

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/81cbbfbc-4a97-4ed1-84a1-8b366605c9db
Type: Detailed Guide
Published: December 18, 2014
Updated: March 6, 2026

> The Medicines and Healthcare products Regulatory Agency (MHRA) oversees a voluntary Phase I accreditation scheme for organizations conducting early-stage clinical trials, particularly First in Human (FIH) studies. This initiative aims to enhance trial safety and foster public confidence by requiring participating units to exceed basic Good Clinical Practice (GCP) standards. To maintain accreditation, organizations must implement rigorous procedures for minimizing participant harm and managing medical emergencies effectively. The regulatory framework is built upon established GCP principles, supplemented by specific safety criteria detailed in the MHRA's accreditation guidance. While the provided document does not list specific violations or inspection dates—as it serves as a general framework rather than an inspection report—it emphasizes that strict adherence to these higher safety standards is mandatory for accreditation. Required actions for organizations include submitting a comprehensive compliance checklist and ensuring that Principal Investigators meet specific postgraduate qualification requirements. Those with significant experience but lacking formal qualifications may seek an exemption through an independent review by the Faculty of Pharmaceutical Medicine. This structured approach ensures that complex clinical trials are conducted under the highest possible safety oversight.

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## Content

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 , 189 KB , 14 pages ) See guidance on the phase I accreditation scheme ( PDF , 277 KB , 20 pages ) See the List of accredited phase I units ( PDF , 130 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 )

## Attachments

- [phase I accreditation scheme compliance checklist](https://assets.publishing.service.gov.uk/media/60d5a80b8fa8f50ac016fc09/Phase_1_Accreditation_Scheme_Checklist_v2_04_March_2021.xlsx)
- [phase I accreditation scheme variation form ](https://assets.publishing.service.gov.uk/media/63161337d3bf7f792d4f52b3/4._MHRA_Phase_I_Variation_Form_v2.1_12_August_2022.docx)
- [phase I accreditation scheme requirements](https://assets.publishing.service.gov.uk/media/67f51ec432b0da5c2a09e152/1._MHRA_Phase_I_Accreditation_Scheme_Requirements.pdf)
- [guidance on the phase I accreditation scheme](https://assets.publishing.service.gov.uk/media/67f51edeb7e44efc70acc32b/2._MHRA_Phase_I_Accreditation_Scheme_Guidance.pdf)
- [Procedure for advice by the FPM on suitability of applicants to serve as principal investigators for first-in-human studies ](https://assets.publishing.service.gov.uk/media/631613458fa8f5021d1dc97d/5._MHRA_Procedure_Document_Advice_On_Phase_I_PIs_v2.1_12_August_2022.pdf)
- [Request for acceptance as a phase I principal investigator for first in human trials](https://assets.publishing.service.gov.uk/media/6723946f8812c830eb8c1e1d/6._Request_to_act_as_phase_1_principal_investigator_for_first_in_human_trials.doc)
- [List of accredited phase I units](https://assets.publishing.service.gov.uk/media/69aaf16b671a8a924c83ee32/List_of_accredited_organisations_FINAL_06_March_2026.pdf)