A12 – Implementing Risk-Based Monitoring – State of play

Following on from sessions at ASC 2015 and the joint one-day ACRP/ARCS RBM summit, this session will focus on the progress and experience of organisations (sponsors, A/CRO’s and sites) using local and global case studies applying RBM practices and technology to optimise trial monitoring – consistent with regulatory and TransCelerate guidance. Neuroscience Trials Australia (NTA) has agreed to participate in a prospective study using risk assessment templates, data analysis and visualisation tools to help document and track monitoring practices. The process of setting up risk plans and target metrics will be presented.  Covance will also provide an update on their global and regional RBM implementation experience. Survey results from local sites participating in RBM studies, identified and selected to document their experiences of transitioning from traditional monitoring to remote monitoring and SDV will also be presented.


Chairperson: Jon Carrano, Pharmsite