The MHRA at the LTHT

1
TheMHRA at the LTHT

• Tomasz Kurdziel
• Quality Assurance Manager Clinical Trials
• 20 April 2006

2
The LTHT MHRA Inspection

• 26 28 April 2006
• 3 days with 2 inspectors
• Inspections are a Statutory requirement

3
The LTHT MHRA Inspection

• Day 1
• 0845 0915 Opening meeting
• 0915 1100 RD Department
• 1100 1230 Pharmacovigilance
• 1230 1300 Lunch document review
• 1300 1440 LGI Pharmacy
• 1430 1800 TMF review Investigator
  interview (2)

4
The LTHT MHRA Inspection

• Day 2
• 0800 1000 TMF review Sub-Investigator
  interview (1) SJUH Pharmacy
• 1000 1200 TMF review Investigator
  interview (1)
• 1200 1300 IT Sponsor Archive Medical
  Records
• 1300 1400 Lunch
• 1400 1530 SJUH Haematology SJUH Radiology
• 1530 1700 TMF review Investigator
  interviews (1)
• Sub-Investigator
  interview (1)
• 1700 1800 Document review
• 1800 1830 Status review

5
The LTHT MHRA Inspection

• Day 3
• 0830 0845 Opening review meeting
• 0845 1200 Document review
• 1200 1300 Lunch document review
• 1300 1400 MHRA summation pre-closure meeting
  (closed)
• 1400 1500 Preliminary presentation
• Inspection
  feedback
• 1530 Inspection end

6
The LTHT MHRA Inspection

• Review of the management process for all clinical
  trials
• Review of the LTHT sponsorship process
• Can the LTHT as sponsor demonstrate that patient
  safety is maintained and trial data is credible?
• Do the sponsor processes reflect at trial level
• Interview of supporting departments staff and
  investigators
• Guidance note for all involved

7
After the inspection

• Initial verbal feedback with findings at close
  out meeting
• Formal written feedback
• LTHT response to findings
• Implementing new systems / processes as a result
  of the findings

8
Contacts

• Primary contact
• Dr Steve Smye
• Director of RD
• s.smye_at_leeds.ac.uk
• Local lead
• Tomasz Kurdziel
• QA Manager Clinical Trials
• t.j.kurdziel_at_leeds.ac.uk
• RD, Leeds General Infirmary
• Tel [phone]

9

• ?
• ANY QUESTIONS