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RDF19 Poster Details

RDF19 Poster Detail

Poster Title 
Improving Quality, Promoting Best Practice through Compliance Checks
Abstract 

The OUH Trust has developed a series of tools to check compliance and assist in the oversight of projects across its large active research portfolio. These tools are easy to use and enable the R&D team to work with study teams to promote best practice.

A Compliance Check is a form of quality assurance. It is independent and separate from routine monitoring or quality control functions.  The brief checks are of great value for oversight of compliance as they are less resource intensive than formal audit and so a greater number of studies can be covered.  With a team of 14 staff, and a portfolio of over 1800 projects, the tool has enabled an increasing number of Compliance Checks to be completed.

Consent Compliance Checks.

Which studies are chosen?

  • Triggered (issues raised)
  • Non-commercial, any type.
  • Status: Recruiting

Approximately 40- 50 are identified each quarter, study teams contacted to confirm status.  Those open and recruiting are allocated to R&D team members to arrange compliance visits.

A proportion of enrolled participants’ medical notes are reviewed for:

  • Copies of signed consent/PIS;
  • Written evidence of consent interviews

Sitefile review:

  • Signed consent forms/PIS version/date vs local C&C dates
  • Delegation log vs consent form researcher signature.

 Safety Compliance Checks.

 Which studies are chosen?

  • Triggered (issues raised)
  • Commercial or Non-commercial
  • Status: Recruiting

Medical notes for participants are reviewed against SAEs or SUSARs in site trial file vs those reported to R&D team for review by Trial Steering Committee.

Reports are written, reviewed and issued with CAPA for the study teams to action.

The Compliance Checks make best use of limited R&D resource to enable study teams to improve the quality of their processes also when overall figures are published in-house, to increase the focus of all research teams on quality.

Presentation would include summaries of findings.

Authors
  • Parker, Fiona R&D Manager: Oxford University Hospitals NHS Foundation Trust
  • Franklin, Jo: Research Support Manager: Oxford University Hospitals NHS Foundation Trust
  • Vichos, Iason: Research Support Manager: Oxford University Hospitals NHS Foundation Trust
  • Flight,Katie: Research Support Manager: Oxford University Hospitals NHS Foundation Trust
Organisation 
Oxford University Hospitals NHS Foundation Trust