Case Study: Non-Interventional Dry-Run Study Implementing Full-Scope RBQM Methodology for Risk Mitigation

About this session

Session: RBQM ADOPTION AND OPERATIONALISATION

The dry-run study serves as a preparatory phase for high-risk projects. This non-interventional case study, enrolling 1% of the target population for the efficacy study, aimed to test processes such as eCOA and sample collection. A comprehensive Risk-Based Quality Management (RBQM) methodology was implemented, which included CP&D identification, risk identification, and management, reduced SDV/SDR, and centralized monitoring through QTLs, KRIs, and targeted review. This approach not only enhanced control over critical data collection but also facilitated swift identification and management of both predefined and newly emerging risks.

Speaker

• MP

  Magda Piskorska

  Central Monitoring Lead · GlaxoSmithKline

  Speaker