This session takes a practical approach to risk-based monitoring. Clinical monitors, project managers, and risk managers learn how to maximize their monitoring resources to have the greatest impact on quality and compliance. Learn about the shift in the monitoring paradigm from the quality-control approach of checking each data point against a source to a quality-assurance (QA) approach that focuses on the systems and processes that generate and report the data. Add the QA methods of interviewing and root-cause assessment to your monitoring toolbox as an effective means of determining the areas in which monitoring resources can have the greatest impact. The speaker will present real findings from a well-established audit program in a risk-based monitoring environment, as well as auditor suggestions, to help you avoid common mistakes.
Discuss the evolving role of the clinical monitor in the new era of RBM and demonstrate how CRAs and project managers must modify their approach to clinical monitoring when taking a risk-based approach.
Contrast system-based monitoring to source data verification-focused monitoring.
Discuss common audit findings from RBM and how they can be applied.
BS, MBA, PhD, CQA, CSSBB,