I will be on a great panel on risk-based monitoring and eSource methodologies at DIA June 16, and I want to highlight a few points from my presentation.
In a risk-based monitoring (RBM) update released in January, TransCelerate defined source data verification (SDV) as “the process by which data within the case report form (CRF) or other data collection systems are compared to the original source of information (and vice versa).”
Medidata Solutions and INC Research co-hosted a seminar on reducing site monitoring costs, sharing major considerations and best practices on implementing a risk-based monitoring (RBM) program. In this final video with Medidata presenters Steve Young, Philip Coran and Mike Petrarca, Steve discusses how cycle time from subject visit to data entry is important for effective RBM, and how we should urge sites to enter visit data quickly.
In this video, we chat with Lori Convy from Sanofi Pharmaceuticals about her E-MUG highlights, and the challenges and benefits of implementing a risk-based monitoring program.