Risk-Based Monitoring – Part Two In Depth Review

Increasing Intensity of On-Site Monitoring a Troubling Trend

Industry Metric Indicates Low ROI with Full Source Document Verification

Has FDA Guidance on Risk-based Monitoring Impacted SDV Coverage Yet?

Clinical R&D organizations across the industry have been steadily moving away from the traditional approach to site monitoring using 100% source document verification (SDV) of subject eCRFs, and into a new paradigm where a targeted sampling of the subject eCRF data is verified against source charts.   

The graphic demonstrates the trend via the average percent of eCRF data marked for SDV from 2007 through 2010. The information is based on data from over 1,500 studies conducted by 50 R&D organizations, compiled by the Medidata Insights metrics warehouse.  

The data reveals a steady, significant downward trend over the four year period, from a high of 85% in early 2007 to a low of 67% in late 2010.  This trend is expected to continue over the coming year and beyond, particularly with the support of the recent guidance provided by FDA in support of risk-based site monitoring practices.   

Each month, an Insights benchmark to highlight emerging trends in clinical development will be featured. For more on the industry benchmarks included with Medidata Insights, please visit 

Industry Data

Applied Clinical Trials-01-01-2012

Clinical R&D organizations across the industry have been steadily moving away from the traditional approach to site monitoring using 100% source document verification (SDV) of subject eCRFs, and into a new paradigm where a targeted sampling of the subject eCRF data is verified against source charts.