NAMSA White Paper: Risk-Based Monitoring: Considerations for Clinical Implementation

In Clinical, Regulatory by Jodi Mullin

Your clinical team (study managers, monitors, clinical research associates) play a critical role in the success of your clinical trial. Their expertise lies in their understanding of the clinical trial process, Good Clinical Practice (GCP), and applicable regulations; managing complex studies, while ensuring subject protection and high quality data through site training and management.

How does Risk-Based Monitoring (RBM) affect these important roles? 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 understated. NAMSA’s latest RBM white paper, “Risk-Based Monitoring: Considerations for Clinical Implementation”, explores a number of elements to consider in order to facilitate proper execution:

  • Team training on RBM – Train monitors on the risks identified in the Study Risk Profile (SRP) and the ways in which the monitoring plan is designed to mitigate those risks. All team members should understand the key indicators and how often pre-specified site metrics will be reviewed. Clinical research associates (CRAs) should have an understanding of how the data management and statistical aspects of the monitoring strategy are designed to detect abnormal values and trends and how these analyses and data summaries complement on-site review of specific subject data points.
  • Customization of internal processes – Customize internal processes to accommodate RBM prior to enrollment. Create monitoring report templates for the various types of monitoring visits (on-site, remote, targeted) to clearly identifying the scope of the visit. If monitoring activities will include the use of database functions, provide monitors and in-house data reviewers a test database so that they can prepare themselves to effectively work through the monitoring process with the research coordinator when not on site. Have a solid site training plan that includes a review of your study’s RBM strategy incorporating the procedures and expectations for the research sites to support remote monitoring and targeted monitoring.
  • Pragmatic site selection – Site selection will be guided by the risks identified in the SRP. If sites have been identified prior to the creation of the SRP, the characteristics of those sites become a factor to consider in evaluating the study risks. In either case, keeping in mind that the SRP is a dynamic, “living” document, there should be an intentional feedback loop between site evaluation and the SRP throughout the selection process.
  • On-site visit preparation – An on-site visit in an RBM study should be highly focused on tasks that can only be carried out in person. It may include reviewing medical history and other available records for adverse events, face-to-face training, regulatory binder review, device accountability, or assessing the ongoing acceptability of the research site for continued participation in the study; not to mention the relationship-building activities that are inherent with face-to-face interactions.
  • Site relationships – Despite a growing understanding that centralized monitoring practices are capable of identifying the majority of critical errors, site personnel may feel that without the checks and balances provided by monitors’ 100% SDV, greater responsibility is placed into their hands to ensure accuracy of data and adherence to the protocol. Anticipate the concerns sites may have and prepare to address them.

Prudent consideration of clinical study elements that are unique to RBM 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.

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.