TransCelerate’s Digital Data Flow Initiative is an attempt to enable the flow of digital study protocol data in order to improve study design and accelerate start-up through automation of processes and setup of study execution systems.
TransCelerate will collaborate on the development of an open-source, vendor agnostic, SDR reference implementation (SDR RI). The SDR reference implementation will enable the format of information from a digitized protocol and other sources to be standardized and thus allow the information to be passed to systems that are used for study execution and data collection, and reused throughout the clinical development lifecycle. To achieve this interoperability objective, the SDR reference implementation will be developed in collaboration first with standards setting organizations (SSOs) and then with technology partners and ultimately deployed as open source.
This document outlines the objectives of the Digital Data Flow initiative and describes the standards, technology, ecosystem, and governance work being undertaken to enable that vision.
This document answers common questions about the TransCelerate Digital Data Flow (DDF) solution.