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Digital Data Flow Solutions

TransCelerate’s Digital Data Flow (DDF) Initiative offers a mechanism to digitize clinical study components to enable interoperability and reuse, across the study lifecycle starting with study design.

TransCelerate has collaborated with CDISC and other stakeholders to develop a standard data model for specifying protocol information, as well as a demonstrated way to connect disparate systems that produce, exchange or consume this information.

The important deliverables/activities from this initiative include:

  1. CDISC Unified Study Definitions Model (USDM) and API specificationsthe foundational standards to create a common, digital data model and method for exchanging protocol information
  2. Study Definitions Repository (SDR) Reference Implementation and associated source code available in open sourcea functioning, example approach to connect systems that produce protocol information with those that consume it to drive study operations – in the form of a reference implementation that stores and facilitates the exchange of protocol information
  3. Engagements with implementers (sponsors, vendors, CROs) who play a critical role in leveraging standards in their software and their protocol digitization approach

In summary, the DDF initiative combines data standards and open-source technology to enable the flow of digital protocol data across systems involved in the design and execution of a clinical trial.

Click the video below to learn more about Digital Data Flow.

Category Title Description
General Information Digital Data Flow (DDF) Overview (MS Word) An overview document that outlines the objectives of the Digital Data Flow initiative and describes the standards, technology, ecosystem, and governance work being undertaken to enable that vision.
General Information Digital Data Flow (DDF) Overview (PDF) Answers to common questions about the TransCelerate Digital Data Flow (DDF) solution.
General Information DDF FAQs Answers to common questions about the TransCelerate Digital Data Flow (DDF) solution.
General Information USDM Materials Link to the CDISC DDF page, where the latest USDM materials are located
General Information DDF GitHub Website Link to the DDF GitHub website, which provides more details on DDF, as well as information on engaging with the DDF initiative in open-source.
General Information Common Protocol Template (CPT) CLI Utility Tool Downloadable Proof of Concept tool that shows how USDM can be mapped to the TransCelerate CC&R Common Protocol Template format, and additionally demonstrates the automated population of an eCPT Word document by loading a USDM file directly from the SDR.
Webinars Digital Data Flow Modernize Clinical Trials by Enabling a Digital Workflow Learn about Digital Data Flow and its role in enabling vendor-agnostic, digital exchange of study definition data in collaboration with technology providers and standards bodies to create a sustainable open-source solution.

 

Link to presentation file.
Webinar date: November 16, 2021. ​

Webinars DDF Webinar – Digital Data Flow: Modernizing Clinical Trials, Updates on Progress and Cross Industry Collaboration (Part 1) Learn about our progress on the initiative and hear from industry peers via a panel discussion for additional insights on Digital Data Flow.

 

Link to presentation file.
Webinar date: March 01, 2022. ​

Webinars DDF Webinar – Modernizing Clinical Trials, Updates on Progress and Cross Industry Collaboration (Part 2) In part two of our two-part series on Digital Data Flow updates and cross industry collaboration, learn about our progress on the initiative and hear from industry peers including EDC solution providers via a panel discussion for additional insights on Digital Data Flow.

 

Link to presentation file.
Webinar date: May 11, 2022. ​

Webinars Digital Data Flow (DDF): Connectathon Results and Outcomes This webinar featured the DDF Connectathon, its participants, and what the Connectathon entailed. Learn about the innovative solutions, demonstrations, and experiment outcomes related to the SDR RI and the DDF system.

 

Link to presentation file.
Webinar date: November 1, 2022. ​

Webinars DDF Webinar: Modernizing Clinical Trials Using Digitized Protocol Information: An Exploration of New Tools for Digital Transformation This webinar supports the 2023 release of DDF R2 by featuring new adoption tools and resources that may help with industry uptake and implementation of USDM and/or SDR. Learn how to get started and how to engage with the DDF Team.

 

Link to presentation file.
Webinar date: December 13, 2023

Videos  DDF Benefits Describes benefits of the DDF initiative.
Videos DDF USDM Overview Describes an overview of the Unified Study Definitions Model (USDM) from the DDF initiative.
Videos DDF SDR RI Overview Describes an overview of the Study Definitions Repository Reference Implementation (SDR RI) from the DDF initiative.
Videos Supporting Automation of Case Report Forms Using Biomedical Concepts Short video introducing Biomedical Concepts and the benefits of this data model concept in the study lifecycle.
Videos Time Points: Supporting Protocol Digitization with Complex Timing Components  Short video introducing Time Points and how it can be used to support complex studies designs.
Videos  Integrating Clinical Content & Reuse (CC&R) and Digital Data Flow (DDF) Initiatives Short video introducing the synergies between TransCelerate’s CC&R and DDF initiatives.
Transformation Resources Digital Data Flow Technology Architecture Scenarios Tool A set of possible scenarios for the technical implementation of the USDM, provided to help companies think about how they might use the USDM and DDF concepts to better enable end to end data flow.
Other DDF Discovery Day Readout Report (Sep 2023) A report detailing the September 19, 2023 TransCelerate DDF Discovery Day event that brought together TransCelerate member companies, select solution providers, CDISC and HL7 Vulcan Accelerator to discuss the industry connectivity and explore the “art of the possible”.

Event Presentations: LINK HERE

Sponsor Company Transformation Tools Getting Started with DDF Link to the DDF GitHub website, which provides more details on DDF, as well as information on engaging with the DDF initiative in open-source.
Sponsor Company Transformation Tools Overview Provides a high-level overview and instructions on how to use the Transformation Tools such as Change Management Journey, Generic Personas, Organizational Self-Assessment.
Sponsor Company Transformation Tools DDF Change Management Journey Assists companies (sponsors / member companies, CROs, vendors) who intend to implement TransCelerate’s Digital Data Flow (DDF) solution as a thought starter for leaders. Serves as a broad outline of the Change Management journey.
Sponsor Company Transformation Tools DDF Personas (Sponsor Company) Describes key generic roles in sponsor company organizations that can help get DDF adopted in the organization or may be impacted by a DDF implementation.
Sponsor Company Transformation Tools DDF Organizational Assessment The purpose of the assessment is to evaluate a company’s preparedness to adopt Digital Data Flow. This assessment is intended for a company’s internal use and is to be completed by functional or business unit leaders within an organization
Sponsor Company Transformation Tool DDF Persona Toolkit for Clinical Data Manager A change resource that describes how the DDF initiative will likely impact some discrete tasks commonly performed by clinical data managers.  The objective is to help clinical data managers understand and better prepare for how to adapt their role and responsibilities to new ways of working within an automated and digitalized study lifecycle.

This toolkit consists of multiple resources that are available to download individually or as a complete toolkit set: Download Full Toolkit

  • DDF Overview: provides an introduction to the DDF initiative
  • Toolkit Overview: describes the toolkit purpose, components, and ways to use it
  • Persona Profile Card: describes the profile for a typical Clinical Data Manager role as described in this toolkit. It can be utilized to help Clinical Data Manager understand the benefits and value of digitalization of data flow within the context of protocol authoring.
  • DDF Change Impacts: articulates potential impacts to a Clinical Data Manager’s role comparing the current state (As-Is) to the anticipated future state (To-Be).
  • Day-in-the-Life: Illustrative flow of “What could a work-day look like with the application of DDF?”
Sponsor Company Transformation Tool DDF Persona Toolkit for Protocol Medical Writer A change resource that describes how the DDF initiative will likely impact some discrete tasks commonly performed by protocol medical writers.  The objective is to help protocol medical writers understand and better prepare for how to adapt their role and responsibilities to new ways of working within an automated and digitalized study lifecycle.

This toolkit consists of multiple resources that are available to download individually or as a complete toolkit set: Download Full Toolkit

  • DDF Overview: provides an introduction to the DDF initiative
  • Toolkit Overview: describes the toolkit purpose, components, and ways to use it
  • Persona Profile Card: describes the profile for a typical Protocol Medical Writer role as described in this toolkit. It can be utilized to help Protocol Medical Writers understand the benefits and value of digitalization of data flow within the context of protocol authoring.
  • DDF Change Impacts: articulates potential impacts to a Protocol Medical Writer’s role comparing the current state (As-Is) to the anticipated future state (To-Be).
  • Day-in-the-Life: Illustrative flow of “What could a work-day look like with the application of DDF?”
Sponsor Company Transformation Tool Persona Toolkit for Information Technology Leadership and Technical Expert Roles A change resource that describes how the DDF initiative will likely impact some discrete tasks commonly performed by the IT Leadership and IT Technical Expert roles.  The objective is to help these roles understand the anticipated benefits of the DDF initiative and better prepare for how their role and responsibilities may need to adapt to new ways of working.

This toolkit consists of multiple resources that are available to download individually or as a complete toolkit set: Download Full Toolkit

  • DDF Overview: provides an introduction to the DDF initiative
  • Toolkit Overview: describes the toolkit purpose, components, and ways to use it
  • Persona Profile Card for IT Leadership: describes the profile for a typical Information Technology (IT) Leadership role as described in this toolkit. It can be utilized to help this role understand the benefits and value of digitalization of data flow across the study lifecycle from study design startup to execution.
  • Persona Profile Card for IT Technical Expert: describes the profile for a typical Information Technology (IT) Technical Expert role as described in this toolkit. It can be utilized to help this role understand the benefits and value of digitalization of data flow across the study lifecycle from study design startup to execution.
  • Building a Case for Change: provides high-level guidance for Business and IT functions to partner on implementing DDF solutions within sponsor companies.