Resources for Decentralized Clinical Trials

Resources for Planning and Conducting Decentralized Clinical Trials

Rapid advances in digital health technologies are fueling a paradigm shift in clinical trial design towards decentralized clinical trials (DCTs), in which research is conducted in part or entirely away from traditional clinical trial sites. The goal of decentralization is to reduce the burden of clinical trial participation, improve recruitment and retention, enroll more participants from groups traditionally underrepresented in research, increase efficiency and allow more frequent, granular measurements in a “real world” setting.

We have compiled resources from regulators and researchers to facilitate the design and conduct of DCTs.

Please bookmark and return to this collection of resources often. The decentralized trial space is rapidly evolving, with additional guidance and resources continuously shared with the research community.

Food and Drug Administration Guidance

The Food and Drug Administration (FDA) plays a key role in guiding decentralized clinical trials by offering non-binding recommendations that help researchers design studies aligned with regulatory standards. These guidance documents support scientific rigor, data integrity, and participant safety across remote and hybrid trial models. For academic teams, they provide a framework to ensure compliance while innovating in trial delivery and access.

Clinical and Translational Science Awards Resources

The Clinical and Translational Science Awards (CTSA) are provided by the National Institutes of Health (NIH) to improve efficiency, quality and impact of the research process. CTSA hubs and researchers have developed and improved the decentralized trial process and have shared their findings, solutions, and resources with the public. Several CTSAs have particularly helpful resources:

Resources from Professional Organizations

Beyond the CTSA network, many other organizations across the country are actively engaged in human subjects research — and in studying how research itself is conducted. These partners contribute valuable insights, tools, and guidance to support decentralized trials.

Disclaimer

The information and resources on this page are educational in nature and are not intended to constitute legal advice, nor do they establish an attorney-client relationship between a clinical researcher or other interested party exploring these resources and any attorney who represents or provides such advice to the University of Washington. Individual users of this page are responsible for their own regulatory compliance with respect to decentralized trials in clinical research.