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.