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Preparing for the Inspection

The purpose of the statutory inspection is to examine the systems used by the University in the conduct of CTIMPs. The MHRA will be interested in processes relating to Regulatory submissions, Laboratories, IMP  management, Contract Management, Project management, Trial-file management, Quality Assurance, Training, Computer systems, Monitoring, Pharmacovigilance, Medical Advisors, Data management, Statistical Analysis, Report writing, Archives and Investigational sites.

 

The MHRA will be interested how these processes work in practice to ensure that:

- robust procedures are in place

- the rights, wellbeing and safety of trial participants are protected

- the trial is conducted in accordance with the principles of GCP

- appropriate Standard Operating Procedures (SOPs) are in place and that these are clearly documented and adhered to e.g.  Reporting of SAEs and SUSARs.

- trials have all the necessary approvals prior to commencing. Relevant authorities may include relevant ethics committee, Sponsor, MHRA, Host R&D office and other trial sites etc.

- adequate pharmacovigilance is in place

 

University RACD preparations

  • Main point of contact for MHRA
  • Awareness Raising- RACD have provided two seminars. The PowerPoint presentations used in this seminar include:      
Medicines and Healthcare products Regulatory Agency (MHRA) by Chris Shaw [279.5 Kb]
Experience of a MHRA Inspection by Aled Rees [447.5 Kb]

Presentations have also been made to the Health Schools Strategy Board and MEDIC School Board.

  • GCP Training – RACD have verified that all members of trial teams have up to date GCP Training.
  • Review of CTIMP List- review RACDs list of CTIMPs to ensure it is up to date. A review of all Sponsor Trial Master File (TMF) using the TMF checklist is being conducted to ensure that all essential trial documentation is held within our files.
  • Clinical Trial Monitoring Visits and Trial Close Down Visits are being conducted by RACD to ensure essential documentation is in place in the CI TMF. If you require a Monitoring Visit please contact the  Research Governance team
  • Risk Assessment/ GAP analysis- all CIs are encouraged to use the Common Findings Risk Assessment (CFRA) Form, to identify areas of risk. An action plan can then be developed to address any gaps.
  • MHRA Inspection working group- an MHRA Inspection working group is being set up. For more information about this group, please contact the  Research Governance Team.
  • Delegation of duties- important that responsibilities and/or delegation duties are clear If responsibilities are not clear for your CTIMP or you need to have an agreement in place, please contact the Research Governance Team.
  • Individualised preparation plans- these will be prepared once we have the final inspection plan.

 

Group/ Unit preparations

 

Individual  Researcher preparation

Please also refer to Aled Rees’ presentation. Aled's CTIMP was inspected by the MHRA in December 2007 as part of the Cardiff and Vale NHS Trust Inspection: 

Experience of a MHRA Inspection by Aled Rees [447.5 Kb]