There is an inherent need within the industry to help clinical research sites understand what should be in place as sites continue to fine-tune their strategies to move forward with decentralized trials, versus what is study specific and sponsor-provided. It is important that the industry understands the best-suited options and ideal course for the adoption of decentralized trials at the site level, and can articulate the needs of the various parties and vendors involved. Several concerns exist in this space and addressing the concerns and the need for a change in the site operating dynamic will be critical to the successful implementation of decentralized trials.

SCRS and the multi-stakeholder Digital Innovation Initiative – Decentralized Trials Workstream team created this document to create a simpler and more streamlined user experience. The intent of this publication is to serve as a reference as sites begin to operate hybrid decentralized trials so they can most efficiently assess their own capabilities and gaps.