Quality & Monitoring

Risk-Based Quality Management

Central and Remote Monitoring

RBQM is now being embraced to address the dramatic increase in research complexity, duration, and cost of clinical research. The latest version of the Good Clinical Practice (GCP) quality standard extends the RBM approach to every aspect of study execution, applying the principles to all areas of quality management, and requiring robust centralized monitoring systems and processes. CHI’s Quality & Monitoring track delivers real world lessons from organizations on the leading edge of implementation and advancing RBQM. Part A: Risk Based Quality Management provides regulatory updates, oversight and governance best practices, implementation strategies, Quality tolerance limits (QTLs) and key risk indicators (KRIs), as well as lessons learned from COVID-19. Part B: Central and Remote Monitoring discusses risk-based monitoring approaches, issues detection, monitoring decentralized trials, and overcoming challenges of ensuring patient safety and data integrity.

SCOPE of Things Podcast