523 The Development of an Institutional Study Start-up Tracker for Industry Sponsored Clinical Trials

Abstract

OBJECTIVES/GOALS: Duke University developed a Project Tracker system to provide transparency into the complex study start-up process for Industry sponsored clinical trials. Partnering with process owners, investigators, research teams, and IT developers, we aimed to reduce timelines for IRB approval, Contract Execution, and Billing/Calendar setup. METHODS/STUDY POPULATION: In 2019, a partnership of administrative stakeholders and IT developers began engaging with the primary populations involved in study start-up: research study teams (STs) and research administrators (RAs). A series of workgroups and feedback sessions revealed common themes with a slightly different scope: STs were interested in the progress of individual projects awaiting approval whereas RAs needed an aggregate view of start-up metrics over time and a way to help troubleshoot delays for individuals. Both groups were hindered by data captured across multiple systems, limited understanding of the entire approval process, and an absence of reliable indicators for delays or outstanding requirements. RESULTS/ANTICIPATED RESULTS: In mid-2021, we delivered a Project Tracker system comprised of two main components, accessible via Dukes myRESEARCHhome portal: 1) a Tableau metrics dashboard for RAs that aggregates retrospective data quarterly, visualizing time to completion of approval workflow milestones with defined outliers, filterable by investigator, unit, or sponsor. 2) a project status tracker for STs (with a complementary view for RAs) that consolidates status information for projects awaiting approval, visualizing the process in a linear fashion with clear indicators of progress and steps awaiting study team action. This involved defining the milestones for each workflow, mapping milestones to application variables, combining the variables in a common data mart, and developing the interfaces with user-centered design. DISCUSSION/SIGNIFICANCE: Given its recent implementation, the impact of the tool on start-up timelines cannot yet be determined. However, our development process led to key insights: a simplified process visualization limited to key milestones allows STs and RAs to understand responsibilities, address delays and data discrepancies, and reinforce institutional process.