532 Application of the CTME Maturity Model in a CTSA Hub: An Initiative to Improve Clinical Research Operations

Abstract

OBJECTIVES/GOALS: The CTSA consortium’s Informatics Enterprise Committee has developed a maturity assessment model for Clinical Trial Management Ecosystems (CTME). This poster will show the improvements achieved using this model at the University of Iowa as well as guidance on how to apply it at other CTSA hubs. METHODS/STUDY POPULATION: The CTME maturity model consists of 11 categories including, study management; regulatory; financial; and reporting. Each category has 3 subcategories: standardization; complexity; and monitoring, while each subcategory is comprised of 1 to 5 maturity statements: initial; developing; aspiring; capable; and efficient. The maturity assessment team at Iowa—comprised of key personnel from clinical research and compliance, accounting, and administration—have used the CTME maturity model to assess Iowa’s research performance across the 11 categories. The initial maturity ratings for each category revealed any gaps in research operations, which led to developing strategies to address the gaps. RESULTS/ANTICIPATED RESULTS: The assessment team initiated a CTME maturity planning project—holding regular meetings to review Iowa’s CTME research maturity and plan changes to improve our CTME maturity ratings. This analysis is done at the statement level to minimize the scope of actions needed and keep resource loads for improvements low. Proposed improvements are assigned to a team member who serves as an “accountability leader.” Such leaders develop action plans aimed at increasing maturity at least one level. The leaders are responsible for acquiring the resources to carry out the plan. Each action plan identifies qualifiers reviewed by the team to confirm that the maturity level has been met. DISCUSSION/SIGNIFICANCE: The CTME maturity model has been shown to be effective in identifying gaps in organizational operations at the University of Iowa, where it has led to incremental steps to improve clinical research operations. The utilization of the model at other CTSA hubs will be discussed at this session.