Introduction to DDF
The initiative will help to modernize clinical trials by enabling a digital workflow to allow for the automated creation of study assets and configuration of study systems to support clinical trial execution. This initiative will establish a foundation for a future state of automated and dynamic readiness that can transform the drug development process.
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 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
Watch a video describing the DDF initiative.
Want to read more about DDF, the objectives, and benefits? Go to DDF Overview.
Latest News & Upcoming Events
Please see links below for newsletters, webinars and conferences featuring DDF.
- 2023.11 - SDR v2.0.2 is live
- 2023.06 - USDM 2.0 Final is live
- 2023.08 - August 2023 Newsletter
- 2023.06 - June 2023 Newsletter
- 2023.04 - April 2023 Newsletter
- 2023.02 - February 2023 Newsletter
- 2022.12 - December 2022 Newsletter
- 2023.12.13 - DDF Modernizing Clinical Trials Using Digitized Protocol Information
- 2022.11.01 - DDF Webinar - Connectathon Results and Outcomes (Recording)
- 2022.09.12-30 - DDF Connectathon Event
- 2022.05.11 - DDF Webinar - Cross Industry Collaboration Part 2 (Recording)
- 2022.03.01 - DDF Webinar - Cross Industry Collaboration Part 1 (Recording)
- 2023.04.20 - CDISC USDM V2.0 Public Review (Link to CDISC)
- 2022.03.29 - CDISC USDM Public Review Start (Link to CDISC)
DDF at Conferences
- 2023.11.5-8 - PHUSE EU Connect
- 2023.10.18-19 - CDISC US Interchange
- 2023.06.25-29 - DIA Global Annual Meeting
- 2023.04.26-27 - CDISC EU Interchange
- 2023.04.18-20 - Decentralized Clinical Trials Conference
Getting Started with DDF
Guidance has been developed to support folks new to DDF and as well as those who want to dive right in.
Click Getting Started for more details.