Preparing for audit and inspection

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Preparing for audit and inspection
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Overview

• Understanding quality systems
• What is audit?
• What is inspection?
• Why audit?
• What do you need?
• Understanding audit
• How to prepare

NHS RD Forum June 2006
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Understanding quality systems

• Quality Control (QC)
• Ongoing checks to make sure outputs are to set
  standard
• Quality Assurance (QA)
• Independent checks that systems in place achieve
  set standard

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What is audit?

• What is not audit?
• Monitoring
• Progress reports
• Inspection

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What is audit?

• Part of QA of sponsor and/or host
• Evaluation of data, documents and resources to
  check performance of systems meets specified
  standards

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What is inspection?

• External audit for regulatory purposes
• Part of QA of regulator
• MHRA
• Human Tissue Authority

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Why audit?

• Maintain participant and staff safety
• Maintain data quality
• Maintain compliance with policies and regulations
• Protect reputation of staff, host and sponsor
• Protect current and future funding
• Improve quality

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Quality cycle
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You cant audit without

• Standards
• Auditor
• Process for conducting audit
• Process for correcting current deficiencies and
  preventing future deficiencies
• System to deal with individual failings identified

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Standards

• Need to audit against appropriate standards
• SOPs, Policies, Protocol
• Research Governance Framework
• Clinical Trials Regulations
• ICH GCP

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Auditor

• Independent of research team
• RD Office of host NHS organisation
• Research Network/ CTU Quality Lead
• Research Office of sponsor
• External organisation under contract
• Trained

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Types of audit

• Self-assessment forms accompanied by random
  checks
• File audits
• Site audits
• Systems audits

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What to audit?

• Minimum 10 of projects
• Risk assessment
• Follow-up
• Voluntary

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What does audit involve?

• Collect evidence and compare against standards
• Document observations
• Assess seriousness
• Recommend actions

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Audit process

• Audit plan
• Meeting
• Audit processes interviews, documents,
  facilities
• Analyse and develop conclusions
• Discuss results
• Report

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What is audited?

• Authorisations (e.g. CTA and ethics, amendments,
  end of trial)
• Adequate training for all site staff and adequate
  training records
• Ensuring clarity of roles and responsibilities
  (e.g. contracts and agreement, delegation log)
• Appropriate knowledge of the trial and quality
  systems in all peripheral departments (e.g.
  laboratories, radiology, medical records)
• Ensure systems and facilities are fit for purpose
  (e.g. computer systems, equipment)
• Conducting the trial in accordance with the
  protocol, including informed consent reporting
  of adverse events / reactions as per protocol
  (and urgent safety measures) unblinding
  procedures and IMP accountability at the trial
  site
• Adequate trial documentation and archiving of
  trial documentation.

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MHRA inspections
The MHRA will be interested in processes relating
to

• Regulatory submissions
• Laboratories
• Investigational medicinal product management
• Contract Management
• Project management
• Trial-file management for selected clinical
  trial(s)
• Quality Assurance
• Training

• Computer systems
• Monitoring
• Pharmacovigilance
• Medical Advisors
• Data management
• Statistical Analysis
• Report writing
• Archives
• Investigational sites

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MHRA inspections

• The Inspection may examine the following
• Is the trial being conducted in accordance with
  the principles of GCP?
• Is there a controlled process for writing, review
  and approval of protocol amendments?
• Is there an adequate pharmacovigilance system in
  place?
• Have the appropriate authorities been notified?
  (including early termination)
• Interaction with ethics system, regulatory
  authority, or collaborator / sponsor

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MHRA inspections

• Inspection plan
• Interviews
• Files
• Documents
• Facilities
• Computers and equipment

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Do

• Be completely open and honest at all times.
• Audit studies chosen for inspection prior to the
  inspection.
• Acknowledge and document areas that you know need
  development.
• Implement a thorough communication strategy.
• Provide information on relevant policies and
  procedures including GCP requirements to staff
  involved in the inspection in advance.

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Dont

• Do not make Major changes to policies and
  procedures in the weeks leading up to the
  inspection.
• Do not write and implement Standard Operating
  Procedure that are overly complex and above the
  required standards. You will be inspected to your
  SOPs as well as the regulatory requirements.
  Failing to meet your SOPs will result in
  inspection finding even if you are meeting the
  regulatory requirements. Where possible use
  guidance instead of rigid SOPs.

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How to prepare

• Review your system against the common findings
  from inspections conducted by the MHRA
• NHS RD Forum Guide
• http//www.rdforum.nhs.uk/docs/mhra_inspection_gui
  de_110406.doc

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• NHS RD Forum
• www.rdforum.nhs.uk