October 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:

Monitoring strategies for Risk-Based Monitoring (RBM) studies can be complex and novel for sponsors, CROs, and sites. A combination of on-site, remote, and centralized monitoring will likely be included in a Risk-Based Monitoring Plan (RBMP). The importance of preparing and supporting clinical personnel and investigative sites cannot be overlooked. Giving an appropriate amount of attention to the process and using the right tools at the right time will mitigate potential errors in the conduct of the study, help your internal team and site personnel navigate RBM, preserve essential relationships, and strengthen partnerships with sites. This white paper will discuss key considerations for RBM study implementation, particularly in the areas of team training, internal processes, site selection, monitoring visit preparation, and relationship-building with clinical sites. Attention to clinical study elements that are unique to RBM and awareness of potential challenges will prevent process inefficiencies and relationship strains, leading to a successful RBM study.