The Syneos Health Podcast

Source Document Review in the Modern World

April 01, 2021 Jeffrey Stewart, Nicole Stansbury and Audra Holleman
The Syneos Health Podcast
Source Document Review in the Modern World
Show Notes

Source Document Review and Source Data Verification have been the gold standard for ensuring data quality and patient safety for more than 30 years.  This review and verification process covers a wide range of material related to study subjects including anything from consent forms and medical histories to lab results and personal diary entries and beyond, consuming a significant amount of time and budget.  In recent years, we’ve seen a drive to find ways to make clinical trial monitoring more effective and cost efficient, especially with the growing use of technologies such as Electronic Data Capture (EDC) systems.  

Audra Holleman, Vice President, Clinical Monitoring and Nicole Stansbury, Vice President, Global Monitoring at Syneos Health, discuss the evolution of what once was a manual and time consuming process of sifting through potentially thousands of pieces of material to a far more efficient and strategic approach driven by advancements of the digital age.

Listen to Nicole Stansbury discuss the importance of risk-based monitoring previously on the podcast in our CORONAVIRUS SPECIAL EDITION, Episode 7: Continuity in Clinical Trials.

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