OVERVIEW: There is a lack of qualified clinical research professionals skilled in clinical trial regulatory management in the academic setting. In addition, professional training courses are costly and/or require institutional affiliation. The SC CTSI's Regulatory Knowledge and Support (RKS) core created a series of free, online, self-study modules to address this deficit in regulatory knowledge and training. These high-quality modules employ a multifaceted approach including educational videos, case studies, interactive quizzes, and provision of core regulatory document templates such as standard operating procedures and review checklists. These modules are designed to educate learners with fundamental and practical knowledge of clinical research auditing, monitoring, and FDA site visit readiness, with an emphasis on investigator-initiated trials. 

GOALS: To create a pool of clinical research professionals who are skilled in regulatory quality management for clinical research in academic settings.

CURRENT AND PLANNED ACTIVITIES: The first module on clinical trial monitoring was launched in 2018 and includes 27 lessons and 13 tools for conducting monitoring.  Since dissemination, this module has been presented nationally and achieved worldwide use. The second module on clinical trial auditing is under development and scheduled for release in February 2021. The final module on site readiness for inspections is planned for development in 2022.  For access to the monitoring module and more information about upcoming modules, click here.

Visit the Webinar and related TrialSite News article, click here. 

Questions about the initiative

Yu Chung
Program Administrator, Regulatory Knowledge and Support

NIH Funding Acknowledgment: Important - All publications resulting from the utilization of SC CTSI resources are required to credit the SC CTSI grant by including the NIH funding acknowledgment and must comply with the NIH Public Access Policy.