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.
SPOTLIGHT EVENTRisk-Based Monitoring – Part Two In Depth ReviewMarch 13, 2014
Cambridge, MassachusettsDownload BrochureRegister
RELATED
- 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?More in Risk-Based Monitoring
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 mdsol.com/insights.
—Medidata Solutions, http://www.mdsol.com
Unifying Industry to Better Understand GCP Guidance
May 7th 2025In this episode of the Applied Clinical Trials Podcast, David Nickerson, head of clinical quality management at EMD Serono; and Arlene Lee, director of product management, data quality & risk management solutions at Medidata, discuss the newest ICH E6(R3) GCP guidelines as well as how TransCelerate and ACRO have partnered to help stakeholders better acclimate to these guidelines.
Phase III PROMINENT Trial Initiated to Evaluate Felzartamab for Primary Membranous Nephropathy
June 30th 2025The global Phase III PROMINENT trial has begun dosing patients to evaluate felzartamab in treating primary membranous nephropathy, a serious autoimmune kidney disorder with no FDA-approved therapies.
Funding Cuts Threaten Diversity in Clinical Research
June 27th 2025In this video interview, Kyle McAllister, co-founder, CEO, Trially, discusses how recent federal funding cuts are likely to undermine research focused on underrepresented populations, and why long-term investment in community-based studies is essential to closing persistent health equity gaps.