Clinical Data Management News & Insights

On 22 September, MHRA published a new set of inspection dossier documents specifically for computerized systems in support of clinical trials.   
 
You can download the new templates on the MHRA GCP hub: https://www.gov.uk/guidance/clinical-trials-for-medicines-good-clinical-practice-inspections

Scroll down to the Pre-inspection documentation tab to find the: 

• GCP inspection dossier template – Computerised Systems
• GCP inspection dossier clinical trial spreadsheet – Computerised Systems
• GGP inspection dossier checklist – Computerised Systems. 
  

MHRA last updated the dossier documents in Dec 2025 to include a new section 13 on Artificial Intelligence and Machine Learning (AI/ML).  The new Computerized Systems documents continue the focus on managing and documenting usage of AI/ML and traditional computerized systems.   

An initial review of the new documents underscores the MHRA emphasis on risk management throughout the entire software development lifecycle including validation status and change control.  

For example in the inspection dossier spreadsheet, the tab S1 Item 4- clinical trials includes questions such as: 

• Number of substantial protocol amendments/modifications
• Number of change controls  
• How many of these change controls related to a protocol amendment/modification 

The ACDM DMEG for Regulatory considerations recommends that data managers review the new documents to ensure that their validation and documentation efforts will support MHRA inspections.