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.

Currently, Study Start-Up (SSU) is comprised of a myriad of multifaceted, multifunctional, multisystem assets created and managed in a manual, labor-intensive, and time-consuming manner.  Working in a document-based environment results in significant manual duplication of effort and the need for extensive reconciliation across SSU assets.

The envisaged solution would address the speed and quality issues by doing the following:

  1. Accelerate study start-up readiness
  2. Eliminating need for reconciling protocol information with the configuration of “downstream” systems
  3. Automate propagation of changes across SSU assets resulting from protocol amendments
  4. Optimize study design by providing real-time, connected design assistance to protocol authors

The following resources on this page articulate the overall vision for the solution and will help technology providers create an innovative, central platform that is accessible, open, flexible and vendor-agnostic towards downstream systems.

What is Digital Data Flow?

 

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Description

This document describes a potential Solution Framework and Conceptual Design that will help technology providers create an innovative, central protocol platform that will be accessible, open, flexible and vendor-agnostic toward downstream clinical applications.

This executive summary provides a high-level overview of a potential Solution Framework and Conceptual Design that would optimize processes and automate asset development from study concept finalization through study start-up (SSU).

This appendix describes a technology-enabled business process for defining a clinical study design supported by a Study Builder platform. This narrative lays out the activities and functionality the tool should support. The final section of this appendix consists of schematics which explain the data flows implied by the business process.