CTSA News

In January 2022, a 36-member work group from 17 institutions gathered to develop a maturity model for Clinical Trial Management Ecosystems (CTME). This effort was formed through the Clinical and Translational Science Award (CTSA) Consortium’s Informatics Enterprise Committee. The committee aimed to clarify technical and organizational complexities in clinical trial operations, set benchmarks, and help leaders identify and address operational barriers.  

The Clinical Trial Management Ecosystem maturity Model includes 11 operational categories for research institution improvement. These categories include study management, regulatory compliance, financial oversight, subject recruitment, and system integration. Each category is evaluated across defined maturity levels. The three evaluation dimensions are standardization, complexity, and monitoring.   

At the University of Iowa, a multidisciplinary team adopted the CTME maturity model to assess clinical research operations. The initial assessment revealed operational gaps and opportunities for improvement. These issues became even more evident during the institution-wide implementation of a Clinical Trial Management System (CTMS). While the CTMS addressed many operational challenges, the CTME maturity framework also highlighted additional opportunities for organizational improvement beyond the scope of a single system. 

The team includes ICTS leadership and subject matter experts from the Human Subjects Office, Holden Comprehensive Cancer Center, Grant Accounting Office, and institutional partners from Human Resources, and Talent Acquisition. This group meets monthly to foster cross-departmental dialogue, streamline processes, and enable strategic planning using the CTME model. These meetings directly led to coordinated and effective improvements. 

These efforts have led to several coordinated improvements across the institution, including: 

• Development and implementation of a New Staff Orientation Checklist to support consistent onboarding and role clarity
• Increased adoption of ICTMS OnCore General Research User Training across General Research roles
• Strengthened connectivity between ICTMS, HawkIRB, and Epic, reducing duplication of information and improving data accuracy
• Progress toward greater standardization in study management, including protocol review, approval workflows, and integration with institutional systems

The CTME maturity model has generated meaningful operational improvements across clinical research operations at UI Health Care. It has also strengthened cross-functional alignment and created a shared structure for evaluating and improving research processes across the institution. These efforts help create a more standardized research environment and ensure improvements are embedded within institutional processes. In the future, the CTME team plans to expand standardized onboarding and training across research units, launch the institutional-wide research staff survey in early 2026, finalize and implement clinical research career progression frameworks, and advance toward higher maturity levels through proactive monitoring and centralized training systems. 

Citation:  

Subramain M, Sprenger K, O’Connell-Moore D, Jones-Bitterman C, Knosp BM. 532 Application of the CTME Maturity Model in a CTSA Hub: An Initiative to Improve Clinical Research Operations. Journal of Clinical and Translational Science. 2024;8(s1):158-158. doi:10.1017/cts.2024.454 

Sehgal S, Pua EC, Rojevsky S, et al. A maturity model for Clinical Trials Management Ecosystem. Journal of Clinical and Translational Science. 2025;9(1):e28. doi:10.1017/cts.2024.1168