Briefing on MHRA routine
inspection of noncommercial clinical trials
Routine Good Clinical Practice (GCP)
MHRA Inspection, University of
Aberdeen 2011
Aims
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MHRA inspections
MHRA inspection at University of Aberdeen
How should staff prepare?
Advice for staff on key areas of weakness
So that:
 You can identify and address any actions required
 You can participate in the interviews with confidence
 University of Aberdeen can demonstrate that clinical
trials are following current legislation and are conducted
to high safety and quality standards.
Why do the MHRA Inspect?
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EU directive 2001/20/EC transposed into UK law
May 2004 as Medicines for Human Use (Clinical
Trials) Regulations 2004
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Legal obligation to conduct Clinical Trials of
Investigational Medical Products (CTIMPs) to
Good Clinical Practice (GCP).
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MHRA is statutory body responsible for
compliance with UK regulations
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MHRA inspect (CTIMPs) on humans covered by
the regulations
3 Types of MHRA Inspection
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Routine
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Triggered
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Requested
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University of Aberdeen inspection is routine
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Provisionally 4 days week of 20 June 2011
Who do the MHRA inspect?
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Legally able to inspect all organisations
‘sponsoring’ or ‘hosting’ clinical trials in the
UK
Includes commercial and non-commercial
organisations
Adapt inspection to organisation type
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Routine inspections focus on systems
What do the MHRA inspect?
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University has systems in place to support conduct of CTIMPs in
compliance with regulations (and GCP).
Specific examples of CTIMPs to demonstrate those systems
Areas of interest include:
 Approval processes and regulatory submissions
 Contract Management
 Trial file and data management
 Quality assurance and monitoring
 Training
 IT systems
 Pharmacovigilance
 Archiving
 Laboratories
 Pharmacy
What happens before the inspection?
■ University notified by MHRA of inspection 4th
February 2011
■ Dossier sent to MHRA on 4th March 2011. Including
a list of CTIMPs (live and complete) to give an
overview of clinical trial activity.
 MHRA provide draft agenda approx 6 weeks prior to
the inspection
 Teleconference to finalise agenda approx 2 weeks
prior to inspection
 University will coordinate the inspection
What are we doing to prepare?
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MHRA Inspection Internal Working Group
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Gap analysis and action plan
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Monitoring and Audit
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Informing staff of the inspection
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Staff training – GCP
What are the key areas of weakness?
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Qualifications and training
Communication
Delegation of duties
Standard Operating Procedures
Evidencing of information
Study file and filing
Pharmacovigilance
Informed Consent
Equipment
Study closure and archiving
Pharmacovigilance
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Sponsor responsibility to ensure events are
reported in accordance with regulations.
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Currently have central reporting (documented
in CI delegation letter) .
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New SOP to be issued with updated process
Monitoring/Audit
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Sponsored studies will be audited to ensure
that essential documents are present in the
Trial Maser File.
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Training record will be required for trial
personnel on a study delegation log.
What can you do to prepare?
Handout available with
recommendations for
addressing key areas of
weakness.
SOPs for
maintaining a Trial
Master File,
Investigator Site File,
Pharmacovigilance
will be available soon
What happens during the inspection?
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Opening meeting – inspectors present
inspection plan
Document review – including medical
notes
Interviews with selected staff
Tour of facilities
Additional requests
Closing meeting – summary of findings
and provisional grading
Interviews with study personnel on
study conduct
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These assess knowledge of GCP and
regulatory requirements, and probe for
evidence of robust processes for ensuring
compliance with GCP
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You should read through the example
questions and answers provided.
Common Themes During Interview:
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Training
Communication
Safety reporting
Protocol procedures &
adherence
Investigational
medicinal product
handling
Informed consent
Approval process
including amendments
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Annual reports to
ethics/MHRA
Statistics and data
handling
Out of hours/leave cover
Randomisation & unblinding procedures
End of trial & archiving
procedures
Dos and Don’ts during Interview
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Be honest - we know we have some gaps and are
addressing them - failure to recognize the gaps is
more problematic than acknowledging the gaps
Avoid being confrontational - esp. avoid giving the
impression that this is ‘bureaucratic detail’
Be ‘alert’ to areas of improvement
Avoid being defensive.
Dos and Don’ts during Interview
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Only answer the question asked
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If mistakes are made or wrong answers given,
correct them at an appropriate time, or ensure
somebody else does so.
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Try your best to correct any deficiencies noted by
the inspectors before they leave
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Demonstrate confidence in your trial systems and
data – you know it best.
Be positive.
Dos and Don’ts during Interview
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Should inspection findings be made, make sure
that you understand them completely – it is
easier to ask the inspector for clarification during
the inspection rather than after the report is
issued.
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Don’t volunteer information
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It is appropriate to challenge a finding made by
an inspector if you are certain they are incorrect,
but do not persist in your objection.
What happens after the inspection?
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MHRA to report issues within 30 days of the
inspection, summarising findings.
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University response will include an action plan,
timelines to address any findings.
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MHRA receive response - will issue a closing letter
and GCP Inspection Statement.
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Future inspections will be performed at a frequency
determined by the MHRA.
 Possible routine GCP inspection of NHS Grampian
Summary
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Review your trial documentation and training files
for staff.
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Have evidence of training (GCP certificate, CV)
Ensure you can explain your role in the trial
Review the typical questions and answers
provided
Familiarise yourself with new SOPs when
available
Be confident of your trial and processes.
Remember that you know your trial better than
anyone else.
Any Questions?
Main Contacts:
 Prof Phil Hannaford – p.hannaford@abdn.ac.uk
 Prof Alison MacLeod – mmd175@abdn.ac.uk
 Dr Gail Holland – g.holland@abdn.ac.uk
Tel: 01224 - 555076
 Lynda Sime – lynda.sime@nhs.net
Tel: 01224 -554656