MHRA Regulatory Inspection

NUH Statutory GCP Systems Inspection (Insp GCP 19162/7990845-0002)

Nottingham University Hospitals NHS Trust (NUH) was inspected by the Medicines and 
Healthcare products Regulatory Agency (MHRA) from the 11-15 March 2024, the 
inspection was conducted to ensure that NUH as a research sponsor is compliant with 
Clinical Trial and GCP regulations. This was the Trusts first GCP inspection in 10 years. 
This paper will summarise the findings of this inspection and provide a brief summary of 
the actions taken (as at Feb ’26). 

MHRA Findings

The inspection findings will be presented as per the MHRA findings categories, Critical, 
Major and other.

Critical 

Two critical findings relating to sponsor oversight and pharmacovigilance were 
identified during the site inspection in March:

• Sponsor oversight of clinical trials: Findings included inadequacies in quality 
  assurance processes, monitoring, risk assessments and essential documentation.
• Pharmacovigilance: This related to Suspected Unexpected Serious Adverse 
  Reactions (SUSAR) reporting, specifically for a trial sponsored by an organisation in 
  Australia, but for which NUH are the sponsor in the UK.

Major

Ten major findings were identified as part of the inspection. These related to clinical 
sample management, contracts and agreements, Electronic Case Report Form (eCRFs) 
/ source data, monitoring, pharmacovigilance, quality assurance, quality systems, 
record keeping / essential documents, statistics and training. 

Other

Seven other findings were identified as part of the inspection. These related to 
archiving, data integrity and control processes, insurance, medical oversight by the PI, 
medical writing, protocol compliance and staff delegation and responsibilities. 

Actions

Following approval of the Corrective and Preventative Action (CAPA) plan from the 
MHRA in January 2025, progress against all actions has been monitored through routine 
CAPA tracking and status review. In total, 62 corrective actions and 68 preventative 
actions were required, with the majority scheduled for completion by 03 October 2025. 

As of the date of this report all but one of the corrective actions have been completed, 
with the remaining action being due for completion later in 2026. All preventative 
actions have been completed.

NUH welcomed the MHRA GCP Inspection of March 2024 and the learning that was 
enabled through the resulting CAPA, so as ensure the continuing high standard of safe, 
GCP compliant clinical research at NUH that benefits our patients.