MHRA Inspection
Recruitment Phase
The MHRA Inspection station follows the Progress Reporting station and precedes the Audit station. This process occurs in parallel with Safety Reporting, Progress Reporting , Ongoing Management & Monitoring, and GCP & Serious Breach Reporting. It also has the potential to occur simultaneously with an Audit, Substantial Amendments, Addition of New Sites & Investigators, Urgent Safety Measures, Temporary Halt, and Early Termination. An MHRA Inspection is a legal requirement for trials within the Clinical Trial Regulations scope. This station is part of the 'recruitment phase' group of stations.
MHRA Inspection
The Medicines and Healthcare Products Regulatory Agency (MHRA) inspect Clinical Trials of Investigational Medicinal Products (CTIMPs) and IMP/Device trials conducted by both commercial and non-commercial organisations. For CTIMPs, MHRA inspectors assess whether sponsors and trial teams have appropriate systems in place to comply with the amended Clinical Trials Regulations and, in the case of IMP/Device trials, both medicines and devices regulations.
Information about the types of inspections conducted and the activities carried out during an inspection is available on the MHRA website. The MHRA applies a risk-based approach to GCP inspection, with details available on the MHRA Risk-Based Inspections page.
The NHS R&D Forum has produced guidance: How to prepare for an inspection for Good Clinical Practice by the MHRA (PDF, 1.1 MB) (.PDF) to support non-commercial sponsors and investigators in preparing for inspection. European Commission guidance documents, particularly Chapter IV, provide additional insights into the inspection process.
Following an inspection, the MHRA issues a formal report outlining the findings. The inspected organisation must provide a written response addressing each finding and detailing the planned corrective and preventative actions (CAPA). Their Guidance for Formulating Responses to GCP Inspection Findings (.pdf) helps organisations to prepare a high-quality response to an inspection report.