The growing consensus among clinical researchers and regulatory authorities is that risk-based monitoring (RBM) is more likely to ensure patient protection and overall study quality, and allows for monitoring that can be more effective than the traditional model of routine visits to all sites with 100% source data verification (SDV).
A number of factors are leading to the paradigm shift in the way that clinical research is conducted. The increasing cost of research and the adoption of EDC technologies that provide real-time access to data have forced the industry to look at optimized methods of conducting clinical studies. In addition, several studies have shown that 100% SDV may not result in higher data quality. All of these factors have led to increased interest in RBM strategies.
Download this whitepaper and learn:
- Risk assessment and planning
- Successful operational approach
- RBM Case Studies
To hear more from PRA, join us at Evidence EU 2014 this 25-26th February where they are sponsoring. For more information about the event, click here