TransCelerate’s Digital Data Flow Initiative seeks 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 has collaborated with others on the development of an open-source, vendor agnostic, SDR Reference Implementation (SDR RI). The SDR Reference Implementation is based on a Unified Study Definitions Model (USDM) developed by CDISC. The SDR Reference Implementation enables the format of information from a digitized protocol and other sources to be standardized and stored centrally. This allows information to be passed to systems through application programming interfaces (APIs) used for study execution and data collection and reused throughout the clinical development lifecycle.
In summary, DDF will combine 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 Overview | 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 | 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. |
| 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 |