Risk-Based Monitoring – A New Way to Ensure Quality Data

PHARMA VOICE
January 2014
Featuring: Dr. Chitra Lele, Sciformix Corporation

Dr. Lele says an optimized monitoring strategy can be based on risk-ratings and KRIs corresponding to other factors such a patient safety (rates of adverse events and serious adverse events), treatment compliance (percentage of patients with delayed or reduced dose or with treatment discontinuation), data management (delays in completing the sending case report forms, query rates, query resolution times), and other aspects of study conduct (actual vs target recruitment rate, percentage of patients with protocol violations, percentage of dropouts).

“This approach requires a priori and ongoing evaluation and analysis of data on KRIs to define the monitoring strategy and plan to adapt it in real time,” she says.

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