• Safe & Effective
  • Kind & Caring
  • Exceeding Expectation
Maintaining Quality Standards

Maintaining Quality Standards

Research Governance describes a set of standards for the management of research that will:

  • Improve and maintain the scientific quality of research,
  • Promote standards of good practice in the conduct of research,
  • Ensure that all research undertaken in the Trust is ethical,
  • Reduce adverse incidents during research projects,
  • Prevent poor performance and misconduct during research.

It is based on the Framework for Research Governance in Health and Social Care produced originally by the Department of Health, 2001.

Research Governance applies to all types of research undertaken in the Trust by both Trust personnel and external researchers working under honorary contracts within the Trust.

The standards are:

  1. Trust management of research,
  2. Ethics,
  3. Quality of research,
  4. Conduct of research,
  5. Health and safety,
  6. Project and financial management,
  7. Management of intellectual property,
  8. Training in research skills,
  9. Consumer involvement in research design and planning,
  10. Information and dissemination of research results.

The Trust aims to ensure that ALL research is performed to the standards of the EU Directive for clinical trials and ICH GCP as part of meeting Research Governance Standards. Research Governance is implemented through the following mechanisms:

  • Trust Peer Review Committee Approval,
  • Research Ethics Committee Approval,
  • R&D/ Trust Approval,
  • Quality Assurance Training/ Assessments,
  • Auditing research
Trial Monitoring

Clinical trials performed at the Trust on behalf of external research organisations are required by Law to meet specific regulatory standards and this includes safety monitoring.

External monitors visit the research teams on a study by study basis to review the quality of our work, systems and process.  As research sponsor, the organisation undertaking the monitoring takes responsibility for ensuring that the trial is being conducted correctly. We actively seek feedback from our sponsors on how well studies are being conducted.

The below chart summarises feedback received in 2014/15 from study monitors.

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A Teaching Trust of the University of Birmingham