The SC CTSI Regulatory Knowledge and Support (RKS) group has made their mark on remote learning post-COVID with the launch of a new, interactive educational module chapter to add to their ongoing Clinical Trial Quality Training Series. “Remote Monitoring of a Clinical Trial Site” was launched in May 2022, and this additional chapter introduces concepts related to remote and hybrid monitoring of a clinical study. The training from this module will allow researchers to continue or begin remote monitoring of a clinical trial site when they cannot be onsite. 

“The ability to perform quality control operations outlined in the remote monitoring module ensures that the data generated from clinical trials would be accurate and verifiable so that the findings can be translated into new or improved treatments for patients,” said RKS Director, Chair and Associate Professor of the Department of Regulatory and Quality Sciences Eunjoo Pacifici, PharmD, PhD, who led the design of the module. Other contributors of the RKS team that worked on this chapter include RKS Associate Director Nancy Pire-Smerkanich, DRSc, MS; and Administrators Annie Ly, MS; and Gordon Wimpress.

The team spent about a year working on the module. The content of the module was pulled from various sources such as the U.S. Food and Drug Administration, the National Institutes of Health, clinical research organizations, and from the expertise and experiences of key stakeholders within the RKS group. The team then developed the content into a script format and slide decks. Next, RKS Project Administrator Gordon Wimpress recorded, edited, and produced the module chapter. The RKS group has previously launched two online modules publicly accessible by clinical research professionals and principal investigators.

“As part of the innovation stage of the implementation science framework for this project, this chapter came about and was made more relevant by the pandemic as the clinical research workforce everywhere had to adopt alternative approaches to monitoring, like remote and hybrid,” said Annie Ly, Project Administrator.

This remote monitoring module is free and self-paced for users. It is open to the entire clinical research workforce, and anyone interested in learning more about clinical trial auditing or monitoring practices. Supervisors and those in industry can also use it for remote monitoring training. Those who finish the modules earn a certificate for completion, which is a great addition to resumes and/or CVs and LinkedIn profiles.

“It is critical for all parties involved in clinical research at sites and as sponsors to be aware of the impacts of remote monitoring and what it entails to ensure that studies progress, data integrity is not jeopardized, and much needed therapies continue to make their way through development,” added Nancy Pire-Smerkanich, DRSc, MS, Assistant Professor of Regulatory and Quality Sciences and RKS Associate Director.

The team is currently in the process of creating the third and last module of the Clinical Trial Quality Series, which will focus on site readiness for inspections and audits. These resources have proven to be useful in teaching the practical skills needed to ensure quality control and assurance of clinical research.

To access this new chapter, please visit https://uscregsci.remote-learner.net, sign in or create a new profile, and navigate to the Course Catalog for USC Regulatory Science/SC CTSI, and choose “Monitoring of a Clinical Trial Site.”