Digital data flow is a public, industry-wide initiative and

the foundational resources are available to all

Adoption starts with understanding. The references below link to the organizations leading the Digital Data Flow (DDF) initiative.

ICH M11 Clinical electronic Structured Harmonised Protocol (CeSHarP)‍ ‍This is the regulatory guideline driving structure protocol submission. Essential reading for understanding where regulators are headed. From this page, you can access the Guideline, Technical Specification, and Template.

TransCelerate Digital Data Flow Initiative‍ ‍This is a landing page with links to many DDF resources.

  • Scroll down for an introductory video about the Digital Data Flow (DDF) initiative.

  • The menu across the top of the page should not be overlooked. Check out the Tools & Resources menu for links to resources including the DDF Solution Collaboration Links/Forum which will lead you to the YouTube DDF Solution Showcase channel, featuring presentations from some solution providers, and a DDF Solution Directory.

CDISC DDF Website Overview: The CDISC “Welcome to Digital Data Flow (DDF) for Clinical Trial Protocols” includes links to many DDF resources as well as CDISC resources.

  • Check out the link on the top of the page to What is the USDM (Unified Study Definitions Model). USDM is the technical standard and backbone for DDF and end-users will need to get familiar with the framework, concepts and some of the terminology.

    • Bonus learning: The informational video referenced at the beginning of the USDM section links to a short video that very succinctly explains the rationale for and the benefit of digital data flow.

    • Additional note: If you’re exploring how to bring the benefits of AI into day‑to‑day clinical trial execution, the strongest practice is to anchor that AI on a semantic ontology, such as the USDM, to minimize hallucinations and the erroneous conclusions that arise from unstructured data.

  • Through the Versions and Conformance Rules tab, you can link to the USDM Implementation Guide (USDMIG 4.0), is a document you will want to keep handy.

  • If you scroll down, you will see a link to the DDF GitHub Repos. If you are not an SDR developer, the GitHub repository can look a little intimidating at first. It’s OK to look around and click on the links and explore the many resources; you won’t be able to do any harm by looking at the files!

Additional insights and learnings:

If these resources seem interesting, but just too much to try and learn while doing the daily work of progressing your pipeline, then connect with AdoptDigitalData for fractional support.