Decentralized clinical trials (DCTs) offer important benefits, including improved participant access, greater convenience, expanded geographic reach, and opportunities to reduce barriers to research participation. As DCT models continue to evolve, they also introduce new stakeholders, including vendors, home health providers, remote study personnel, and digital platforms, which can create uncertainty regarding roles, responsibilities, and oversight expectations. While research activities have become increasingly distributed, accountability frameworks have not always kept pace.

This session brings together perspectives from academic and commercial institutional review boards (IRBs) and site operations to examine how decentralized trial models are implemented and managed in practice. Attendees will explore how engagement determinations, regulatory frameworks, and IRB reliance models intersect in practice and how common breakdowns in accountability lead to predictable operational consequences. Attendees will leave with practical strategies to clarify roles, improve coordination, and reduce compliance risk in decentralized and multisite research environments.

CEU: 1.0 ACRP

Speakers:

• Daniela Bashllari, MHA, Assistant Director of Regulatory Affairs, Oncology Clinical Trials Support Unit (O-CTSU), University of Michigan

• Kelly FitzGerald, PhD, CIP, Executive IRB Chair & VP of IBC Affairs, WCG

• Purna Garimella, MS, CIP, RAC, Executive Director, HRPP & IRB, Indiana University