The MHRA at the LTHT

1
TheMHRA at the LTHT

• Tomasz Kurdziel
• Quality Assurance Manager Clinical Trials
• January 2006

2
MHRA and Inspections

• Under the EU CTD each Regulatory Authority is
  legally obliged to perform inspections (GCP / GMP
  / GLP)
• 54 gt pharmaceutical / CRO / clinical labs /
  Niche providers
• 20 gt Investigator sites
• 6 gt non-commercial sponsor inspections (Nov
  2005)
• Average 3 major / critical findings to date
• Specific modalities for non-commercial research
• Due to a significant increase in organisations
  acting as non-commercial sponsors, the MHRA is
  looking at doubling the number of inspectors

3
Criteria for performing an inspection

• Performing trials for the purpose of licensing an
  IMP
• Number of clinical trials being performed (CTX /
  DDX / CTA)
• Number of patients enrolled
• Use of 3rd party contractors
• Previous inspections
• Collection of data for non-commercial sponsor
  (Dec 2005 Jan 2006)

4
Notifying the LTHT of the inspection

• LTHT notified early November with 28 days to
  respond with
• Clinical trial activity from May 2003 (625)
• Details of CTIMPs sponsored by LTHT (22)
• Specific documentation relating to (452 page
  dossier)
• QA systems SOPs Policies Management /
  department structure
• Pharmacy IT Labs Equipment maintenance
  site maps

5
The LTHT inspection

• Request for further information gt Jan 2006
• Inspection plan to be prepared by lead inspector
  and discussed with the LTHT gt giving about 4
  weeks notice of inspection
• 4 day inspection by approximately 5 inspectors
  reviewing
• LTHT sponsor process
• Staff interviews QA systems SOPs
• Sponsor acceptance and management of CTIMPs
• Pharmacy Labs IT Archiving
• Approximately 5 LTHT sponsored CTIMPs
• Staff interviews Approvals TMF Staff
  experience / training
• Source data CRF database analysis final
  report
• SAE reporting Pharmacy archiving

6
Interim action

• Finalise QA systems SOPs database website
• Confirm LTHT sponsorship for remaining CTIMPs
• QA to provide support to LTHT researchers in
  preparing for the inspection
• QA to liaise with departments by reviewing
  systems and processes

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Issues relating to CTIMP inspections

• Secure and confidential storage / handling of all
  data and documents
• Ensure that all essential staff working on the
  trial have signed / dated a staff signature /
  responsibility log and that a current signed /
  dated copy of their CV is on file in the TMF / or
  a reference made in the TMF of where the CV is
  located within the department.
• Adherence to LTHT IT policy (passwords / servers
  / backup)
• Ensuring that study documents and data files are
  stored securely for a minimum of 15 years after
  the completion of the trial, by the research team
  or in the central LTHT archive.
• Ensuring that medical records for patients
  participating in clinical trials are easily
  recognisable to medical records staff as
  requiring storage for 15 years
• That SAEs are recorded and reported to the
  sponsor, MHRA and REC.
• That the Pharmacovigilance processes, as stated
  in the protocol are strictly adhered to.
• That SAEs are recorded on a standard form and
  that they are reviewed causality to the event
  is assigned by a medically qualified member of
  the research team and signed / dated by that
  researcher.

8
After the inspection

• Initial verbal feedback with findings
• Formal written feedback
• LTHT response to findings
• Implementing new systems / processes as a result
  of the findings
• Re-inspection

9
Non-commercial sponsor findings

• Systems and processes
• PV
• Archiving
• Pharmacy
• CTA / REC approvals / documentation
• Computer systems

10
Implications to the LTHT of findings

• Re-inspection within 6-12 months
• Stopping of CTIMPs
• Preventing further sponsorship of CTIMPs
• Legal action for non-compliance of regulations
• Reduction of the clinical trial portfolio

11
Thank You

• to all
• Investigators
• Research Nurses
• Study co-ordinators
• Research offices / YCRN
• LTHT Management / departments
• for their help in preparing the initial
  submission and general support.

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Contacts

• Tomasz Kurdziel
• QA Manager Clinical Trials
• t.j.kurdziel_at_leeds.ac.uk
• Gillian Murphy
• QA Associate
• g.eddison_at_leeds.ac.uk
• RD, Leeds General Infirmary
• Tel [phone]

13

• ?
• ANY QUESTIONS