“Ensuring Quality: A Pilot Study to Establish a Monitoring Pool for Investigator-Initiated Trials”

Improving effective monitoring of investigator-initiated trials (IITs) at academic medical centers is one of the challenges undertaken by the Southern California Clinical and Translational Sciences Institute (SC CTSI). In a February 18, 2020 webinar hosted by the Trial Innovation Network, the SC CTSI team of Dr. Pacifici and Dr. Pire-Smerkanich from the Regulatory Science Department and Dr. April Armstrong and Dr. Nicki Karimipour from SC CTSI presented on the on-going development of IITs focused self-study monitoring tools developed over the last half year. The presenters shared the experience gained from a recently completed four-study real-world pilot intended to train a nucleus of senior coordinators in clinical trial monitoring using the self-study monitoring tools. The pilot study results support the SC CTSI self-study monitoring tools as a platform for academic centers around the country to internally create pools of effective monitors for IITs and ultimately contribute to the improvement of IIT-based data quality and patient safety.

Visit the Webinar here.  For a related TrialSite News article please click here.

For general information on Education Initiatives, click hereHighlight posted on March 4th, 2020