Inspection Visit

During the visit

It is envisaged that the inspection will take 1 week and involve 2 or more GCP Inspectors, although this is not certain. A final inspection plan will be provided to the Sponsor roughly 1 week prior to the visit. The inspection will include:

• Opening meeting
• Documentation review of the University/School/Department SOPs
• Facility Visits and Site Inspection
• Inspection of several clinical trials to test systems
• Interviews with key personnel, e.g. Chief / Principal Investigator, Research teams (e.g. Research Fellow, Research Nurse) , RACD, Laboratories, IT and Archiving facilities
• Closing meeting where the MHRA will provide feedback of general findings.

Information to be made available

For trials selected by the MHRA for review, the following should be made available (where applicable):

• trial related documents including the Trial Master File, Case Report Form (including adverse and serious adverse event /SUSAR reports), ethics committee documentation, drug accountability and reconciliation records
• CVs, training records, job descriptions for staff involved in clinical trials and related activities (including Quality Assurance)
• Policies, SOPs and related working practice documents
• Quality assurance plans and schedules
• Computer system validation documentation
• Maintenance/service records for relevant equipment including computer systems.