Decentralised clinical trials (DCT) use technology, processes, and services to reduce or eliminate the need for onsite visits. Use of DCT components within clinical trials is becoming widespread and protocols are pivoting from using DCT components as rescue tools during the COVID-19 pandemic to including them as integrated decentralised research methods. To date, there is no consolidated guidance for what DCT component content should be included in the protocol. To enhance clarity, completeness, and repli cability in clinical trial protocols incorpora ting DCT components, this article outlines a simple scoping process for information gathering and summarises some common considerations around frequently used components. The objective of this article is to provide protocol authors with tools, resources, and guidance to better support the development of clinical trial protocols that include DCT components.
Medical Writing. 2023;32(1)12-18. https://doi.org/10.56012/rtqr5570
Editor-in-Chief
Co-Editors
Managing Editor
Victoria White
Deputy Managing Editor
Alicia Brooks Waltman
Associate Editors
Section Editors
AI/Automation
Biotechnology
Digital Communication
EMWA News
Freelancing
Gained in Translation
Getting Your Foot in the Door
Good Writing Practice
Pablo Izquierdo / Alison McIntosh
In the Bookstores
Publications
Medical Communications/Writing for Patients
Medical Devices
My First Medical Writing
News from the EMA
Pharmacovigilance
Regulatory Matters
Regulatory Public Disclosure
Louisa Ludwig-Begall / Sarah Kabani
The Crofter: Sustainable Communications
Veterinary Writing
Editors Emeritus
Layout Designer
Chris Monk