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Medicines and Healthcare products Regulatory Agency (MHRA) Statutory Good Clinical Practice (GCP) Inspection of Cardiff University

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Title: Medicines and Healthcare products Regulatory Agency (MHRA) Statutory Good Clinical Practice (GCP) Inspection of Cardiff University


1
Medicines and Healthcare products Regulatory
Agency (MHRA) Statutory Good Clinical Practice
(GCP) Inspection of Cardiff University
2
The plan for today
  • The inspectors
  • Inspection process
  • Inspection Outcomes
  • Preparing for the Inspection
  • Experience of an inspection

3
The Inspectors
GCP Inspectors
Offices York Welwyn Garden City Market Towers
GMP Inspectors
Group Manager Inspections
GLP Inspectors
GPvP Inspectors
Expert Inspectors
Serious Breach of GCP
4
What does an inspection involve?
http//www.mhra.gov.uk/CON2024532
5
Pre-Inspection Dossier
  1. Complete list of Clinical Trials (from May 2005)
  2. Organisational charts
  3. Overview of all facilities
  4. Description of archiving arrangements
  5. SOP index
  6. Detailed procedures in relation to
  7. Trial management
  8. Quality control and assurance
  9. Computerised systems
  10. Equipment maintenance
  11. Supply of Investigation Medicinal Product
  12. Laboratory procedures
  13. Activities carried out by CU or contracted out by
    CU

6
Clinical Trial Activities
Any activity involved in the running of Clinical
trials at our institution
Archiving
SOPs
Statistics
Adverse Event reporting
Contracts
Data Management
Drug Management
Trial reporting
Project Management
Training
Laboratory
Randomisation
Computer Systems
Regulatory approvals
Study Monitoring
Trial Files
7
What happens during the visit?
  • 1 week inspection by at least 2 GCP Inspectors
  • Documentation review
  • University/School/Unit SOPs
  • Facility Visits
  • Inspection of several clinical trials to test
    systems
  • Interviews with key personnel, e.g.
  • Chief / Principal Investigator
  • Research teams e.g. Research Fellow, Research
    Nurse
  • RACD
  • Laboratories
  • IT
  • Archiving facilities
  • Inspection plan can change

8
Inspection outcomes
  • 3 categories of findings
  • Critical
  • evidence that
  • i) the safety, well-being or confidentiality of
    trial subjects have been or have potential to be
    jeopardised,
  • ii) the clinical trial data are unreliable
  • iii) there are a number of Major non-compliances,
    indicating a systematic quality assurance
    failure.
  • insufficient or untimely corrective action
    regarding previously reported Major
    non-compliances
  • Major
  • significant and unjustified departure from
    legislative requirements that may develop into a
    critical issue unless addressed,
  • a number of departures from legislative
    requirements and/or established GCP guidelines,
    indicating a systematic quality assurance
    failure.
  • Other
  • departure from legislative requirements and/or
    established GCP guidelines, but it is neither
    Critical nor Major.

9
Response to Findings
  • Organisation must respond within 30 days
  • Critical Findings or a number of Major Findings
    may lead to suspension of one or all CTIMPs in
    the organisation
  • Organisation response
  • Analysis of findings
  • Corrective Action
  • Preventative Action
  • Plans of assessing effectiveness of preventative
    action
  • Timelines
  • Disputed findings

10
Common Findings
  • Contract Agreement Preparation
  • Lack of written agreements with collaborators
  • Inconsistencies between protocol and contract
  • Delegation of duties without agreements/systems
    in place
  • Lack of identification of CI and all trial team
    at outset
  • Quality System
  • Lack of SOPs
  • Insufficient time between issuing and
    implementing SOPs, leading to training issues
  • Team meetings not documented
  • Training
  • Inadequate knowledge of Clinical Trial
    Regulations
  • Lack of GCP training amongst trial team
  • Informed Consent
  • No record of consent
  • Incorrect version

11
Common Findings
  • Investigational Medicinal Product (IMP)
    management
  • Inadequate provisions for storage of IMPs
  • Insufficient records for the chain of custody
  • Inadequate procedures for QP release
  • Lack of documentation confirming role of
    Pharmacy/CI
  • Pharmacovigilance
  • Inadequate Pharmacovigilance systems and/or
    inadequate use of systems in place
  • Lack of awareness of legislative requirements
  • Standardisation or arrangements for un-blinding
    SAEs arising from blinded trials
  • Annual safety report to MHRA not made
  • Data management
  • Security of trial documents/data
  • Inadequate retention period
  • Lack of clarity of data entry and data query
    processes (Source Data Verification)

12
Common Findings
  • Information Management
  • Lack of assurance that systems are fit for
    purpose
  • Lack of evidence of system security
  • No clarity on arrangements for backing up data
  • Regulatory Affairs (e. g. Clinical Trial
    Authorisations)
  • Remarks on MHRA approval letters not followed up
  • Unclear indemnity arrangements
  • Unclear sponsorship arrangements for DDX studies
  • Annual and end of study reports not sent
  • Filing of essential documents
  • Poorly maintained site files
  • Poor document control and management
  • Forms not signed or not completed correctly
  • Laboratory
  • No evidence of how equipment is maintained,
    calibrated and serviced

13
University (RACD) Preparations
  • Pre-Inspection Dossier
  • Awareness Raising
  • Delegation of duties
  • Review of Clinical Trial list
  • Clinical Trial Monitoring Visits - essential
    documentation
  • MHRA Inspection working group
  • Risk Assessment/GAP analysis based on common
    findings from previous MHRA inspections
  • Individualised preparation plans

14
How can Research Groups/Units prepare?
  • Awareness raising
  • Familiarity with legislation, internal and
    external guidance
  • ICH GCP (Topic E6) http//www.emea.europa.eu/pdfs/
    human/ich/013595en.pdf
  • University Research Governance web page
    http//www.cf.ac.uk/racdv/resgov/index.html
  • www.ct-toolkit.ac.uk
  • GAP analysis
  • Essential documentation / Unit SOPs
  • Action plan

15
How can Researchers prepare?
  • Familiarity with legislation, internal and
    external guidance
  • ICH GCP (Topic E6) http//www.emea.europa.eu/pdfs/
    human/ich/013595en.pdf
  • University Research Governance web page
    http//www.cf.ac.uk/racdv/resgov/index.html
  • www.ct-toolkit.ac.uk
  • Essential Documentation - Self-assessment of the
    trial using Trial Master File checklist
  • Approvals
  • Document Control
  • IMP management
  • Delegation Logs
  • SOPs
  • Pharmacovigilance
  • Equipment

16
Summary
  • Anyone involved in Clinical Trials
  • Co-operation and engagement
  • Early Preparation
  • Action plan to remedy issues

17
Contacts
  • Research Governance Team
  • resgov_at_cardiff.ac.uk
  • X79277 (01798 79277 from Heath)
  • Chris Shaw
  • Matthew Harris
  • Kathy Pittard Davies

18
Medicines and Healthcare products Regulatory
Agency (MHRA) Statutory Good Clinical Practice
(GCP) Inspection of Cardiff University
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