Using a Clinical Quality Risk Management (QRM)

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Speakers:
Michael Macri, Director, Strategic Services, inVentiv Health Clinical
Jeffrey Fetterman, President, ParagonRx, an inVentiv Health company

Implementation of centralized monitoring is significantly more than simply shifting certain clinical monitoring activities that were once conducted on site. In today’s monitoring environment which has been enabled by recent guidance and reflection papers by regulators on clinical risk-based approaches to monitoring clinical study quality, monitoring activities should now be designed to track two types of risks identified in the clinical risk assessment:

Fixed risks, which are controlled by specifications in functional plans such as the clinical monitoring plan and data management plan; and
Dynamic risks, which are controlled by tracking key risk indicators (KRIs) which are defined in the systematic clinical risk assessment to trigger corrective actions if the KRI values exceed predetermined thresholds.
Implementing all of this with the appropriate processes, enabling technologies, and workflow management is the topic of a case study concluding the presentation.

Keywords: risk management, RBM, Centralized monitoring