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RDF19 Poster Details

RDF19 Poster Detail

Poster Title 
Highlighting risk in sponsored studies: a risk categorisation tool

The MHRA promotes risk adapted approaches in study management. However sponsors are unsure how to implement this practice whilst still maintaining adequate oversight. All studies submitted for sponsorship at UHDB (a non-commercial sponsor) are reviewed to ensure that the study meets the relevant standards and to determine how the study will be managed prior to submission for ethical and HRA approval. Formerly, all studies were treated similarly and risk was not considered, this was time-consuming (with resulting cost implications), and was often excessive for simple studies. UHDB R&D Department aimed to implement a risk-proportionate approach to sponsorship whilst maintaining an appropriate level of oversight.

Study risk areas were determined by key members of the R&D Department. A risk categorisation checklist and scoring system were developed ensuring that the main risk areas were highlighted objectively, unlike the former subjective process of combining interpretations from a committee. The validity of the checklist was assessed; 5 members of the R&D Department subjectively risk categorised 20 dummy studies and the new risk categorisation checklist was completed for the same studies. The aim was to use the comparison between the two processes to define cut-off values within the scoring system thereby classifying each risk level, but instead the validation process showed a poor correlation between the checklist and the combined interpretation. The checklist was adapted and was again used to risk categorise the dummy studies, on this occasion the validation process demonstrated a stronger correlation between the checklist and combined interpretation. The updated checklist appears to proportionately assign risk and has now been released for completion for all UHDB-sponsored studies. It allows for risk based oversight (including monitoring), highlights and captures risk areas, determines if a comprehensive risk assessment is required and minimises unnecessary checks for simple studies, whilst demonstrating sponsor oversight of essential areas.

  • SKIRROW, Sarah (Quality Assurance Manager: UHDB)
  • THORNHILL, Joanne (Head of Clinical Trials & Research Governance: UHDB)
  • JONES, Michael (Medical Statistician: UHDB)
University Hospitals of Derby & Burton NHS Foundation Trust