Pulling The Trigger On Risk-Based Monitoring

By Rick Morrison, CEO, Comprehend Systems

Site monitoring is an essential element of clinical trials, ensuring quality and integrity of a clinical investigation. Monitoring uncovers potential problems such as data entry errors or missing data, assures that study documentation exists, assesses the familiarity of the site’s staff with the protocol and required procedures, and provides a sense of the overall quality of a site.

For clinical trial sponsors, 100 per cent source data verification (SDV) of research data is an extremely timeconsuming and expensive process, involving thousands of hours of manpower for a single trial. Beyond just being expensive, 100 per cent SDV is often ineffective, because there is so much data that the reviewers are overwhelmed and can’t see the forest for the trees. It’s no wonder that the FDA is now recommending that sponsors shift toward implementing more targeted, risk-based monitoring practices. Reducing site visits has the potential to dramatically cut costs, increase effectiveness and improve safety by better allocating available resources to where they’re needed most.