The Regulatory Knowledge and Support team at the Southern California Clinical and Translational Science Institute (SC CTSI) has developed a three-part, self-paced educational series focused on addressing monitoring, auditing, and inspection readiness for investigator-initiated trials, which they have recently published about in a manuscript in the Clinical Researcher, the flagship journal for the Association of Clinical Research Professionals.

The Clinical Trial Quality Training Series fills a crucial need for researchers and their staff. If a trial is investigator-initiated, it means the principal investigator designed and implemented the trial independently, rather than one sponsored by a pharmaceutical company. While industry-sponsored trials have built-in processes for conducting monitoring and auditing their own trials, investigator-initiated trials do not. Access to training and education on these relevant topics is crucial to the success of this clinical research.

“Quality in clinical research does not happen by accident—it requires training, preparation, and a clear understanding of regulatory expectations. Our team developed this series to help investigators and their research staff build the knowledge and confidence needed to successfully navigate monitoring visits, audits, and FDA inspections. Ultimately, strengthening these capabilities helps improve the integrity and reliability of investigator-initiated trials,” said Eunjoo Pacifici, PharmD, PhD, Chair and Associate Professor in the Department of Regulatory and Quality Sciences in the USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences. She is also the SC CTSI Director of Regulatory Knowledge and Support.

The team developed the Series over the course of eight years, launching the final module, “Site Preparedness for FDA Inspection,” in May 2024. They held focus groups composed of 15 to 25 individuals from clinical research units at the University of Southern California and the SC CTSI, who provided feedback on the modules through focus group discussions and surveys. Surveys delivered at the completion of the courses indicate high satisfaction with the content. For example, the average satisfaction rate across all the modules is around 93%.

Since their launch, the modules have been viewed over 90,000 times from learners in the United States and globally, including Brazil, India, Kenya, Canada, Australia, and the United Arab Emirates. Learners can earn certificates of completion and digital badges, which can be included in online resumes and websites such as LinkedIn. Learners who complete all three modules can earn a special digital badge.

In terms of next steps, the team is in production on a new regulatory series, “Special Considerations for Emerging Technologies,” slated to launch in 2026. As for the existing modules, the team plans to continuously update the modules to ensure relevance and compliance with evolving regulations.

“The success and global reach of our online modules demonstrate the profound impact of accessible, high-quality clinical research education,” said Tony Succar, PhD, MScMed, Assistant Professor in the Department of Regulatory and Quality Sciences in the USC Alfred E. Mann School of Pharmacy and Pharmaceutical Sciences and Co-Director of SC CTSI Regulatory Knowledge and Support. “By equipping learners with the expertise to conduct ethical research, implement effective monitoring practices, and ensure auditing and inspection readiness, we are strengthening the foundation for investigator-initiated trials worldwide.

More information about the Clinical Trial Quality Series, including how to enroll, can be found on the new SC CTSI Learning Network.

You can read the manuscript, "Enhancing the Quality of Investigator-Initiated Trials Through Self-Study Modules", in The Association of Clinical Research Professionals' Clinical Researcher.