OVERVIEW: The Regulatory Knowledge and Support (RKS) core of the SC CTSI has developed a self-paced educational tool to teach clinical research professionals about best practices for monitoring investigator-initiated (IIT) clinical trials, which often have no extant monitoring function, as their sponsor-funded trial counterparts. First initiated in 2016, this educational offering represents a collaborative effort between two SC CTSI core groups, RKS and Clinical Research Support (CRS). 

GOALS: Design and implement a robust, vetted and effective method for monitoring IITs. 

CURRENT STATUS: Clinical research coordinators from the CRS pool completed the training, and participated in a pilot-testing effort to establish the efficacy of the educational offering as well as the process of implementing a monitoring initiative for IITs.


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.