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:
- CDISC Unified Study Definitions Model (USDM) and API specifications – the foundational standards to create a common, digital data model and method for exchanging protocol information
- Study Definitions Repository (SDR) Reference Implementation and associated source code available in open source – a 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
- 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.
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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
|
| 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
|
| 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
|