ABSTRACT
Consisting of a variety of required components-including but not limited to quality risk assessments, a written Quality Risk Management Plan, and strategic, centralized data reviews-the revision underscores the importance of a robust RBQM framework to ensure clinical trial execution in compliance with GCP. In this article, we will examine the overall value of ICH E6 (R2) to sponsors, as well as how COVID-19 has and will continue to influence sponsors' consideration of risk-based monitoring as a key component of clinical trial operations. [...]if they have not proactively identified key data and processes that could bring potential risk, they run the danger of getting "lost in the weeds" and overlooking risk factors that later breached tolerance limits and resulted in issues that had some level of impact on the study and its results. At Rho, we consider a robust RBQM framework to include dedicated quality risk managers, RBQM templates to assist with creating the plans required by ICH E6 (R2), a strategic approach to data review, among other components.