Journal for Clinical Studies
Smart approaches to monitoring, such as centralised, remote, risk-based and adaptive monitoring which are emerging, can reduce the need for on-site monitoring visits and source data verification (SDV) while achieving the objectives of monitoring more effectively. It is recognised that the traditional approach of on-site visits and 100% SDV is not optimal, and cannot, on its own, effectively achieve the primary objectives of monitoring, which are to ensure the rights and safety of participants and
the reliability of safety and efficacy results. Both the US FDA and European Medicines Agency are urging greater reliance on centralised monitoring practices to identify when on-site monitoring is truly required and how on-site monitoring can be optimised through metrics collected from centralised monitoring methods.
Read the full article.JCS-Nov 2013 – Under-Surveillance