Systematic Risk Assessment
for Risk-Based Monitoring

What is Risk-Based Monitoring?

Clinical studies are monitored to assure data integrity and the safety of human subjects within these studies. Traditionally, this monitoring involved visits to the investigator sites to verify all source data. In 2013, both FDA and EMA issued guidance or reflection papers intended to enhance data integrity and human subject safety by welcoming strategies for a risk-based approach to monitoring studies. As FDA cites, “There is a growing consensus that risk-based approaches to monitoring, focused on risks to the most critical data elements and processes necessary to achieve study objectives, are more likely than routine visits to all clinical sites and 100% data verification to ensure subject protection and overall study quality.” 
Reference: U.S. Department of Health and Human Services. Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring, August 2013.