Risk based monitoring is a strategic monitoring practice which aims to shine the spotlight on problematic study areas, to maximize oversight of the most vulnerable data. The efficiency promised by RBM arises from the ability to detect the sources of data require the most attention, and distribute finite resources for oversight to the most problematic areas. This distribution aims to optimize attention on data sources which are in the most need of oversight, while decreasing attention on sources of data that have historically proven to be reliable.
In a new talk, Cytel’s Sangeet Kumar identifies a pivotal new role for data managers in the practice of risk-based monitoring. A subject matter expert in CDM with fluency in pharmaceutical due diligence, Sangeet had nearly a decade of experience working within industry leaders like inVentiv Health, Parexel and Quintiles, before joining Cytel as a CRM manager.
Sangeet’s strategic insight stems from the idea that RBM is, “[B]ased on technologically-enabled, risk-based algorithms.” Therefore Sangeet observes that, “Highly configurable statistical engines coupled to a rules database similar to a clinical or a safety database could be developed with ability to rate study sites on specific pre-defined “Risk” Metrics.”
Using these statistical engines and risk metrics, data managers can transfer already well-developed skills towards improving the efficiency of RBM.
Sangeet's research has led to the following results:
Results: By implementing RBM remotely by DM team quality and integrity of data can be improved as SDV becomes ongoing and continuous with interim signals to identify risk. The expected reduction in SDV is around 45% to 65%. More time will be spent on automatic checks, and less on on-site monitoring, which means that the focus will be on ensuring quality for critical data.
Sangeet will present his talk at SCDM India on December 12, 2015 at 2:30. Other Cytel participants at SCDM India 2015 will include Anil Golla and Sangeetha Gandepalli. Here is a full list of activities.
Implementing Quality in Risk Based Monitoring - a DM Challenge
Sangeet Kumar (speaker)
Data Standards and My Experience
Sangeetha Gandepalli (session leader)