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Compliance In Focus
Posted by Brandy Chittester on Mon, Jul 15, 2013

Risk-Based Monitoring: Is It an Obstacle?

Recently, my inbox has been inundated with training opportunities for Risk-Based Monitoring.Risk Based Monitoring  Since the FDA’s release of its latest guidance on monitoring in August 2011, the pharmaceutical and device industries have made this a hot topic of discussion.  It seems the term, Risk-Based Monitoring, in spite of the guidance, has become an obstacle.  What is Risk-Based Monitoring?  And what is causing the confusion?  Perhaps the clearest definition for Risk-Based Monitoring was given by a presenter at the Global ACRP Conference this year in Tampa.  She referred to it as “Intelligent Monitoring”.  That says it all, doesn’t it?  Visually, I see the AT&T Commercial (It’s Not Complicated “Infinity”) with all the kids sitting around a table discussing big numbers with a grown-up.  When a little girl responds “Infinity times infinity” the grown man responds by motioning that his head just burst.

It’s not complicated.  It’s using resources intelligently.  It’s taking the time to understand the protocol, the study sites involved, and the study objectives.  It’s then monitoring the study data and site compliance in a unique fashion as opposed to the not so “tried and true” approach of 100% Source Data Verification (SDV) and regularly scheduled onsite monitoring visits every four to eight weeks.  It’s making compliance assessments throughout the course of the study and conducting onsite monitoring visits based on those assessment needs.  It’s utilizing contemporary resources, such as remote access to electronic medical records and electronic case report forms, to verify data points when able.  And it involves more than the monitor – it involves the whole study team. Check out our "Monitoring as a Mindset" whitepaper for more information on this idea.

Risk-based monitoring incorporates lean production long used by the manufacturing world.  Lean production considers, “With the end in mind, what do we need to do to get there?”  and “How do we do it faster and with less cost, yet with the same or better quality?”.  Lean production considers value to the customer.  Who are our customers?  As the monitoring CRO or sponsor, wouldn’t our customers be the FDA (marketing application approval) and ultimately the population who will consume the product?  If, as the sponsor, we are bringing useful products to market more quickly and potentially at a lower cost (because we incurred less cost), are we not meeting the needs of our ultimate customer, the user of the product?

Finally, if you think about it, FDA has used the same risk-based approach to their inspection process.  They don’t verify every data point with source, but they sure check those data points critical to supporting the primary and secondary endpoints.  They review consent forms and the consenting process to ensure protection of the human subjects enrolled, as well as, trend issues and review study documents to determine compliance with the applicable regulations. 

Have you attended Risk Based Monitoring Training?  Has it changed the way you approach the monitoring of your studies?  Please share your experiences with us. 

Photo Credit: wwarby

Centralized vs. OnSite Monitoring

Topics: Risk-Based Monitoring, FDA, Clinical Monitoring

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