NAMSA White Paper: Risk-Based Monitoring: Setting up the Structure for a Systematic Approach

In Clinical by Jodi Mullin

Are you considering a Risk-Based Monitoring (RBM) strategy for your clinical trial, but are unsure of where to start? RBM has been touted as an innovative method of reducing monitoring costs without sacrificing data integrity. Guidance documents and position papers have described the RBM strategy as a focus on risk management from concept to conclusion with the goal of efficiently attaining superior data quality while protecting the safety of study participants. The practicalities of implementing the strategy, however, are not always clearly defined.

NAMSA has developed a systematic approach to RBM that aligns with recommendations from the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This strategy involves the utilization of global resources, advanced technology and tools, and an expert cross-functional team to identify critical risks and continually assess data integrity and patient safety throughout the life of the trial.  To learn more about this approach, check out the first white paper in NAMSA’s RBM series, Risk-Based Monitoring: A Cognizant Approach. 

To support this systematic approach, NAMSA’s RBM team specially designed four template documents: The Study Risk Profile (SRP), Risk-Based Monitoring Plan (RBMP), Centralized Data Monitoring Plan (CDMP), and Periodic Review of RBM Site Metrics (Dashboard). These documents, which are customized to fit the unique characteristics of the study, essentially act as a roadmap, walking you through important considerations for RBM studies. Beginning with the SRP, the risks of the study are identified and quantified to determine whether RBM is justified for the study and if it is, what level of monitoring is appropriate. The RBMP and CDMP represent the nuts and bolts of how the monitoring will be carried out. The Dashboard provides real-time data regarding the critical risks identified in the SRP. The Dashboard is reviewed throughout the study to determine whether current monitoring methods are appropriate. All documents remain flexible, “living” documents, designed to be revised based on real-time data. These documents serve as a framework upon which study decisions are documented, justified, and communicated within the cross-functional team as well as to any regulatory body.

NAMSA’s expertly designed RBM approach and comprehensive template documents provide a path to achieving not only efficiency and long-term cost savings, but also quality that equals or surpasses that of a traditional approach.

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Authors:

Jodi Mullin received her B.A. in Psychology at the University of Wisconsin – Madison and her Masters of Social Work degree from the College of St. Catherine/University of St. Thomas in St. Paul, MN. She is a Certified Clinical Research Associate and currently works with NAMSA managing research sites on pre and post market clinical studies.