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Experience of a MHRA Inspection Aled Rees Senior Lecturer Centre for Endocrine and Diabetes Sciences. Timelines. Trust informed June 2007 Pre-inspection dossier submitted July 2007 Informed early October that my trial had been chosen

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Presentation Transcript
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Experience of a MHRA Inspection Aled ReesSenior LecturerCentre for Endocrine and Diabetes Sciences

timelines
Timelines
  • Trust informed June 2007
  • Pre-inspection dossier submitted July 2007
  • Informed early October that my trial had been chosen
  • A Randomised, Double Blind, Placebo-Controlled Study Of The Effects Of Dehydroepiandrosterone Replacement On Vascular Function In Patients With Primary And Secondary Adrenal Insufficiency. Eudract No 2005-000115-10
  • SAE list for all trials sent late October
  • Inspection visit 3rd – 7th December 2007
why me
Why me?
  • MHRA chooses 5-6 trials to inspect
  • Unlikely a random process and will be chosen to best test the range of systems involved e.g. a multi-centre study, investigator-initiated single centre etc
  • 1 University-sponsored trial chosen…mine!
the weeks leading up to the inspection
The weeks leading up to the inspection

OR

?

  • Neither
  • Plan:
  • Familiarise myself with all regulations pertaining to clinical trials
  • Ensure the trial master file was as good as it could be
reference resources accessed
Reference resources accessed
  • GCP training update (Tanya Symons course) July 2007
    • Useful up-to-date information on ICH-GCP, EU Clinical Trials Directive and subsequent amendments, ethics committees, informed consent, pharmacovigilance & reporting requirements etc
  • National research ethics service (www.nres.npsa.nhs.uk)
  • MHRA clinical trials (www.mhra.gov.uk)
  • Draft records management guidance Cardiff University
  • CU/Trust SOP for trial master file
  • Cardiff University RACD site SOPs, especially reporting of research related adverse events
  • Data protection guidance for researchers (Trust guideline)
  • Clinical trials toolkit website (www.ct-toolkit.ac.uk)
  • Others
the interview
The interview
  • Day 4 Interview 17 – DHEA 3294E
  • Interviewed in the Clinical Research Facility
  • 1 and a quarter hours
  • Present: Me (obviously!), Senior GCP Inspector, Trust R&D Co-ordinator (to take notes)
  • Co-investigator/nurse not interviewed for my trial but interviewed separately for all others (University sponsored and Trust being inspected)
the interview areas covered
The interview – areas covered
  • Job history & research experience
  • GCP training of trial staff and when undertaken (also CVs)
  • Training in study specific techniques, calibration records discussed
  • Archiving & retention of data
  • Where will final data be stored?
  • Discuss roles and responsibilities of CI and PI (both as a single centre study)
the interview areas covered8
The interview – areas covered
  • Trial set-up – who was involved? (Co-investigators, Clinical Trials Pharmacist, St Mary’s Pharmaceuticals Unit)
  • Communication with co-investigators
  • Co-investigator training (certificates in master file)
  • Trial set-up difficulties – IMP shelf-life/stability issues discussed
the interview areas covered9
The interview – areas covered
  • What is the difference between a substantial and non-substantial amendment?
  • Any amendments to the study and how dealt with? (change to washout period & approved by sponsor)
  • I brought up the delay in submission from St Mary’s of a substantial amendment (in relation to batch stability data) – accepted by MHRA but commented upon in inspection report
the interview areas covered10
The interview – areas covered
  • Pharmacovigilance – AE and SAE reporting
  • What would you do if an SAE occurred? What is an SAE?
  • Who do you report to?
  • Timelines of SUSAR reporting etc
  • What if a co-investigator decided an adverse event had occurred? Could he make a decision? What if CI/PI was on leave?
  • Could you override co-investigator’s decision?
  • SOPs for adverse event reporting – Trust v University and Trust incident form also completed
the interview areas covered11
The interview – areas covered
  • Unblinding – emergency and end-of-study
  • Envelope storage, on-call pharmacist, protocol for emergency unblinding in TMF
  • Pharmacy issues and St Mary’s – accountability logs, delegation of responsibilities
  • End of study unblinding ‘SOP’ discussed
  • Data storage – where held? Identifiable information? Back up.
  • Source data verification and archiving facilities
  • End of study statistical plans
the interview areas covered12
The interview – areas covered
  • Trial steering committee?
  • Risk assessment at study planning
  • Master file and 5 case notes (list provided by MHRA a week or so before inspection) available for review but I believe may not have been looked at as insufficient time
the aftermath
The aftermath
  • Attended end of inspection report on the Friday afternoon
  • Trust – 1 critical and 4 major findings later downgraded to 0 critical and 4 major findings
the aftermath14
The aftermath
  • Inspection report issued to the Trust February 28th
  • 11 page summary!
  • Findings pertaining to DHEA 3294E (Minor/Other)
    • 3.3.2 Data management and statistics
      • There was no documented process for database lock and unblinding of blind codes for both …. & DHEA study
conclusions
Conclusions
  • Do not underestimate the importance of the inspection
  • Be familiar with all the important regulatory documents
  • Ensure your site file is spot on
  • Be honest & remember this is an inspection of systems not really of individual trials
  • The individual trials are picked to test that appropriate systems are in place and that these are running well
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