Submitted by Renee Pridgen, Associate Director, Clinical Research Informatics

The DCRI’s Integrated Clinical Events-Safety Surveillance (ICE-SS) is seeking to evaluate the potential for clinical trial endpoint events to be identified based on SAE narrative free text reports. Clinical Research Informatics (CRI) is tasked with piloting the National Center for Biomedical Ontology (NCBO) Annotator as an adjudication supplement to the current CEC trigger method. The goal is to see if the Annotator is a viable solution for providing automated, reliable, and accurate identification of suspected events not already identified by the standard Clinical EventsCommittee (CEC) processes.

Based on promising results from the preliminary tests, an additional round of testing is underway. The results of the second review will determine next steps. The team anticipates statistics and programming involvement to help develop algorithmic processes and fine tune the output.

The study is led by Mary Williams, Clinical Research Informaticist. Other team members are Renee Pridgen, Associate Director, Clinical Research Informatics; Brian McCourt, Director, Clinical Research Informatics; Matthew Wilson, PL, CEC; and Linda Lillis, Associate Director, ICE-SS.