The Association of Clinical Research Professionals
Decentralized Clinical Trials (DCTs): An Introduction with ICH E6(R3) Guidance
Decentralized Clinical Trials (DCTs) are transforming how research is designed, conducted, and experienced.
This self‑paced course introduces the core concepts, models, and terminology associated with DCTs, with a strong emphasis on the principles outlined in ICH E6(R3). Learners will explore common decentralized and hybrid trial approaches, examine the advantages and challenges of implementation, and review key operational, regulatory, and ethical considerations that influence feasibility and success. The course also highlights essential tools and technologies and provides guidance on how these components can be thoughtfully integrated into clinical trial workflows.
At the end of this course, participants should be able to:
Define DCTs and explain their role in the conduct of clinical research.
Describe common DCT models and approaches used across the clinical research landscape.
Evaluate the advantages and challenges associated with implementing decentralized elements.
Analyze key considerations when incorporating DCT components into clinical trials.
Identify DCT tools and technologies and assess their potential use in workflows.
“This ACRP training course provided practical insight into modern risk-based quality management, decentralized clinical trial models, and the integration of digital health technologies into real-world clinical research.”
José Seijas-Amigo, PharmD, PhD, CPI (ACRP)
Head of Clinical Trials Unit – Cardiology & Intensive Cardiac Care
University Hospital of Santiago de Compostela