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:  This 3-module series is freely available for public access. Launched in 2018, the first self-study module on monitoring of clinical research concepts has been implemented across USC and CHLA. To date, it has been viewed by 900+ users across 37 countries.  Launched in September 2021, the second module, “Auditing of Clinical Research Site”, has been viewed by 180+ users across 27 countries. As part of our commitment to maintain and update this educational tool, a fourth chapter on Remote Monitoring of Clinical Research was added to the first module in May 2022 and since then, 35 individuals across 23 countries have viewed this chapter. The final module on Site Readiness for Audits/Inspections is planned for launch in 2023.

To access these modules themselves, visit here to create your free account.

For information about SC CTSI’s collaboration with DK Kim International Center for Regulatory Science on this initiative, visit here

Questions about the initiative

Karen Manrique
Project Administrator, Regulatory Knowledge 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.