Through the CTSA “Beyond Boundaries” initiative, the University of Iowa championed the Research Unit Network (RUN), a National and International collaboration of Clinical Research Units (CRUs) to support the mission of improving translational science.
CRUs are central hubs that accelerate translational research. They provide the infrastructure, expertise, and services needed to manage study protocols, ensure compliance, and support research participants and their families. By bridging innovation and practice, CRUs streamline research by supporting the full translational spectrum from early clinical and pre-clinical studies to patient-centered outcomes.
RUN was launched in July 2018 to enhance these functions and to foster collaboration, communication, and sharing among CRUs nationwide. The University of Iowa started this initiative with eight partner institutions. Since inception, RUN has grown to include 65 institutions (59 CTSA recipients or affiliates) across 29 states and one international partner. This group represents 124 professionals working together and committed to improving CRU operations. RUN members vary in geographic location, type of clinical research (outpatient vs. inpatient), resources, and research subject volume.
RUN is much more than a professional network; it is a catalyst for solving translational science challenges. Monthly video calls and an active online platform enable members to share expertise, brainstorm strategies, and create solutions for budgeting, staffing, participant recruitment, Standard Operating Procedure (SOP) development, EPIC (Electronic Health Record) integration, and innovative solutions for adapting to public health emergencies.
The network’s value was particularly evident during the COVID-19 pandemic. RUN became a vital support system for CRUs managing disruptions to how we facilitate essential trials. Members shared strategies for maintaining studies, implementing remote solutions, ensuring participant safety, and managing the influx of COVID-19–focused clinical trials in response to the public health emergency. These shared experiences were documented in Journal of Clinical and Translational Science (JCTS) publications, providing knowledge that can inform CRU operations broadly and support the translational science goal of accelerating research impact (Subramain et al., 2021).
RUN empowers all its members to build and improve CRUs by providing adaptable guidelines, peer-driven SOPs, and a newly developed CRU Maturity Model. The CRU Maturity Model is a benchmarking tool inspired by CTSA’s Informatics Enterprise Committee (now BIDS), that guides operational advancement across workforce, financial, participant, and regulatory domains. As Sehgal et al. note, “The Maturity Model provides a structured framework to assess and improve clinical trial operations across multiple domains, enhancing efficiency, quality, and compliance” (Sehgal et al., 2025). These resources strengthen the backbone of clinical research far beyond Iowa.
RUN has further emphasized data-driven improvements through a longitudinal study of protocol deviations at the University of Iowa CRU. Over the course of four years, the initiative revealed that by 2024, 80% of deviations were reported within 30 days, marking a substantial improvement from earlier years when reporting was less timely and consistent. The analysis also showed that 63% of minor incidents occurred during study setup, prompting targeted interventions such as assigning CRU liaisons, creating start-up checklists, modifying workflows, and increasing lab staffing. These measures reflect NCATS principles of using evidence to guide decisions and improve operational efficiency.
Feedback from members is that RUN is especially helpful to new CRUs and staff members:
“Being a relatively new unit, RUN has been helpful in guiding me in the [CRU] processes,” and “we are just starting out and all the information and experience is very helpful, especially the budget.”
“I just wanted to take a moment to say how much I appreciate being part of the Research Unit Network. Over the past couple of years, I’ve learned so much from the group’s shared experiences, resources, and insights. I currently lead a chapter of the International Association of Clinical Research Nurses (IACRN), and during a recent discussion with our members, I shared what a valuable resource this network has been.”
RUN’s story, rooted in Iowa’s commitment to going “Beyond Boundaries”, embodies the NCATS mission. By connecting CRUs, accelerating operational excellence, and producing generalizable solutions, RUN exemplifies NCATS principles of cross-institution collaboration and producing generalizable solutions that address unmet needs in clinical research.
References:
Subramain M, et al. Impact of COVID-19 on Clinical Research Units (CRUs). J Clin Transl Sci. 2021;5(1):e167.
Comellas AP, et al. Research Unit Network (RUN) as a Learning Research System. J Clin Transl Sci. 2023;7(1):e99.
Subramain M, et al. 519 The Research Unit Network (RUN) as a Learning Research System. J Clin Transl Sci. 2022;6(s1):107.
Sehgal S, Pua EC, Rojevsky S, Becich MJ, Fehrmann J, Knosp BM, Wilcox A, Talbert JC, Craven CK, Starren J. A maturity model for Clinical Trials Management Ecosystem. J Clin Transl Sci. 2025 Jan 22;9(1):e28. doi: 10.1017/cts.2024.1168. PMID: 40052053; PMCID: PM