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Perspectives, Concerns and Myths… Talking Risk-Based Monitoring with Investigative Sites

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When it comes to the risk-based monitoring (RBM) conversation, the investigative site personnel is such an important stakeholder. Yet for the most part, they've been out of the RBM loop. We haven't always engaged with sites early on, helping them understand the language and what RBM actually means. And with so much talk about remote monitoring, reduced source document verification (SDV), targeted monitoring etc., it's been confusing for sites to understand the difference between scanning and faxing patient files, for example, and implementing an RBM strategy. Even more of a reason why it's essential to train clinical research associates and site monitors, and to advocate for change management. In this video, Amgen's Elspeth Carnan, INC Research's Jill Collins and Medidata's Steve Young discuss the importance of educating site personnel and cultivating the relationship between sites and sponsors. Working with sites more collaboratively can help them better understand the RBM methodology, and can ultimately help us bring cheaper, faster and safer medicines to patients. *Guest blogger Elspeth Carnan is Executive Director, Centre of Operational Efficiency, Innovation and Process Improvement at Amgen. *Guest blogger Jill Collins is Senior Director of Integrated Clinical Processes Clinical Innovation at INC Research. *Guest blogger Stephen Young is a Principal Engagement Consultant at Medidata. TWEET THIS:

[VIDEO] Perspectives, Concerns and Myths...Talking Risk-Based Monitoring with Investigative Sites @Amgen @INCResearch

— Medidata (@Medidata) November 12, 2014

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