After issuance of the final guidance document by FDA on Oversight of Clinical Investigations – A Risk-based Approach to Monitoring, the clinical trials industry is embarking on a paradigm shift to reap the benefits of Risk-based Monitoring (RBM). Considering the importance and current interest related to RBM, Cecilia Stroe, Editor of Journal of Clinical Studies talks with Ashok Ghone of MakroCare, USA.
http://jforcs.com/jcs/wp-content/uploads/2014/02/Risk-based-Monitoring-Moving-Forward.pdf