Venue: London, United Kingdom
EFGCP in association with ACRES, EORTC and UCL are pleased to announce an interactive Workshop intended to develop practical strategies and approaches for risk management and risk-based monitoring in clinical trials.
The workshop is being developed in close collaboration with thought-leaders from Health Authorities, industry, CROs, academia and patients representatives. Up to now discussions on risk management have been mainly theoretical and the practicalities of ‘how to’ has not been defined. Yet nobody is sure how much is actually ‘enough’ and how much is too little. Research Organisations 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” of what is critical to patients’ safety, integrity & rights, and data integrity. At the end of the workshop a discussion round with regulators is planned to give participants guidance whether the approaches developed during the workshop would be acceptable in their view.