Medicines and Healthcare products Regulatory Agency (MHRA) Statutory Good Clinical Practice (GCP) Inspection of Cardiff University. The plan for today. The inspectors Inspection process Inspection Outcomes Preparing for the Inspection Experience of an inspection. The Inspectors.
Welwyn Garden City
Group Manager Inspections
Serious Breach of GCP
Any activity involved in the running of Clinical trials at our institution
Adverse Event reporting
3 categories of findings:
i) the safety, well-being or confidentiality of trial subjects have been or have potential to be jeopardised,
ii) the clinical trial data are unreliable
iii) there are a number of Major non-compliances, indicating a systematic quality assurance failure.