IRT: An Untapped Source Of Historical And Real-Time Data For Risk-Based Monitoring

Risk-based monitoring has attracted the support of a diverse group of organizations in recent years. Regulators have released guidance encouraging the use of risk-based approaches to clinical trial quality, vendors have created technologies to support such methods, and large pharma companies have pooled their resources to drive adoption. Yet, despite this flurry of activity, the industry has overlooked a potentially useful source of real-time and historical data.