EFGCP Focuses on Implementing Risk-Based Monitoring

The European Forum for Good Clinical Practice (EFGCP) is organizing an interactive workshop intended to develop practical strategies and approaches for risk management and risk-based monitoring in clinical trials. The event, to be held on June 16 and 17 at University College London (UCL), UK, is being put together by the EFGCP’s Education Working Party in association with the Alliance for Clinical Research Excellence and Safety (ACRES), European Organization for Research and Treatment of Cancer (EORTC), and UCL.

 “Up to now discussions on risk management have been mainly theoretical and the practicalities of ‘how to’ have not been defined. Yet nobody is sure how much is actually ‘enough’ and how much is too little,” stated the organizers. “Research organizations are starting to create their approaches to risk assessment and risk-based monitoring and yet there are still questions which need to be addressed, especially on how to define, justify and ‘validate’ what is critical to patients' safety, integrity and rights, and data integrity.”

The workshop has been developed in collaboration with thought leaders from health authorities, industry, CROs, academia and patients’ representatives, according to EFGCP. At the end of the meeting, a roundtable discussion with regulators is planned to decide whether the approaches developed during the workshop are likely to be acceptable. Those delegates who are more knowledgeable on risk assessment and management will drive during the workshop the discussion based on their ‘hands on’ experience, others that are less familiar with these concepts can adopt a more observational role.