Wednesday, 14 March 2018, 11:00 AM-12:00 PM EST
The Psychology of Metrics
Presented by: Leslie Sidor
Description: Oversight of clinical studies and the activities required to support clinical trials is a necessary activity to maintain data and scientific integrity and to protect the safety and welfare of subjects. Whether the work is conducted by a contract research organization or the sponsor, a consistent oversight model is required that is integrated into the sponsor’s Quality Management System (QMS). At Biogen, the R&D oversight model determines ownership for defining key quality indicators (KQI’s), the measurement of process health and assessment of output quality. In this model, metric owners are the individuals who are accountable for the quality and compliance of a specific process output (e.g. Trial Master File, statistical analysis plan, etc.). The process owner needs to
• Select KQI’s aligned to the fundamental R&D principles which define quality expectations by the senior leadership team
• Set meaningful tolerance thresholds based acceptable risk which trigger corrections and/or CAPAs based on the quality impact
In addition to specific process oversight, overall process performance health is collected and reported in a dashboard. The dashboard is used as a governance tool to inform leaders of potential quality and compliance risks in R&D.
In this presentation, Biogen’s oversight model and QMS will be reviewed in the context of identifying KQI’s, setting tolerance thresholds, acceptance of risk, escalation of issues and governance. A case study will be presented to bring these concepts to life and share the tools, practical points to consider and learnings identified along the way.
Registration coming soon
RQAP Re-registration units: 0.25 GCP/non-GLP