September 2015

Author:
NAMSA Risk-Based Monitoring Working Group:
Therese Everson, MBA;
Sharon Herbert, PhD, MBA;
Jennifer Mischke, MPH;
Jodi Mullin, MSW;
Tyson Rogers, MS;
Katie Schaaf, MS;
Jill Visor, MS

Abstract:

The success of your clinical study is dependent on many factors, but one of the most crucial is a comprehensive plan, developed through careful consideration of study objectives and potential pit-falls. From protocol development to site selection, a design that leads to optimum participant safety and quality data requires a methodical approach with active participation from experts on a multi-disciplinary team. This is perhaps most essential when you are planning to conduct a study utilizing Risk-Based Monitoring (RBM). In fact, though RBM may be seen as a method of reducing major costs over the life of a study, successful RBM will necessitate additional resources be utilized up-front. Beginning with a thorough risk assessment to identify and quantify the particular risks of the study and determine whether Risk-Based Monitoring is appropriate, sponsors, clinical project managers, biostatisticians, and data management personnel work together to set the stage for a quality study. When RBM is found to be justified, utilizing cross-functional expertise and a reliable, proven method of conducting the study should result not only in efficiency and saved resources in the long-run, but also in quality that equals or surpasses that of a traditional approach. This is due to RBM’s focus on risk management, which is intended to reduce the impact of risk to acceptable levels by proactively identifying and tracking issues, and addressing them effectively to prevent undesirable consequences. RBM requires energy and resources to be highly focused on the essentials – a clean, targeted, and intelligent approach.