Quality by Design and Risk-Based Monitoring
Over the past decade, the clinical research industry’s standard to meet regulatory monitoring obligations has involved frequent and regular onsite monitoring visits with 100% source data verification (SDV). The belief that “more is better” continues even with new evidence that on-site monitoring practices do not necessarily guarantee patient safety and data quality. An electronic survey was conducted by the Clinical Trials Transformation Initiative (CTTI) in 2008 to assess the clinical monitoring practices utilized across different types of organizations involved in clinical research. The results published in 2011 have highlighted the heterogeneity in monitoring practices between clinical trial organizations, and the key conclusion is that traditional monitoring is inefficient and doesn’t always lead to increased patient safety and data quality in clinical trials.