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

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The inspectors inspection process inspection outcomes preparing for the inspection

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


The inspectors inspection process inspection outcomes preparing for the inspection

The plan for today

  • The inspectors

  • Inspection process

  • Inspection Outcomes

  • Preparing for the Inspection

  • Experience of an inspection


The inspectors

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


What does an inspection involve

What does an inspection involve?

http://www.mhra.gov.uk/CON2024532


Pre inspection dossier

Pre-Inspection Dossier

  • Complete list of Clinical Trials (from May 2005)

  • Organisational charts

  • Overview of all facilities

  • Description of archiving arrangements

  • SOP index

  • Detailed procedures in relation to:

    • Trial management

    • Quality control and assurance

    • Computerised systems

    • Equipment maintenance

    • Supply of Investigation Medicinal Product

    • Laboratory procedures

  • Activities carried out by CU or contracted out by CU


Clinical trial activities

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


What happens during the visit

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


Inspection outcomes

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.


Common findings

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


Common findings1

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)


Common findings2

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


University racd preparations

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


How can research groups units prepare

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


How can researchers prepare

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


Summary

Summary

  • Anyone involved in Clinical Trials

  • Co-operation and engagement

  • Early Preparation

  • Action plan to remedy issues


Contacts

Contacts

Research Governance Team

[email protected]

X79277 (01798 79277 from Heath)

Chris Shaw

Matthew Harris

Kathy Pittard Davies


The inspectors inspection process inspection outcomes preparing for the inspection

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


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