US Interchange Debrief: Summary Ideas 15-OCT-2026

[MelissaQTanner]

On 15-OCT-2026 team meeting, US Interchange was discussed and these ideas were shared.
Note: This is an AI summary based on the transcript from that meeting.

US Interchange Debrief: Summary of Ideas

Darren Moreland (presenter)
The session went well: the 30-minute Q&A filled easily and feedback was strongly positive, though two presentations in 25 minutes was tight. His Phase 3 ideas:

• More complex USDM examples. Move past the CDISC pilot study to a real protocol with cycles and branching.
• CRF specializations. The audience is ready for them, and a release is in progress.
• The biomedical concept journey. Show how a BC links to activities and assessments, where its C-code goes, and how it connects to SDTM, CRF, and eventually analysis specializations.
• CDISC API value. Clarify which membership levels get API access, address cost concerns, and provide example API requests and pipelines.

Michael Molter

• Digitization dominated the conference, from the opening plenary onward.
• Many organizations have built their own protocol digitization tools.
• Open question: those tools were built without DDS, so how will DDS fit into existing workflows?

Marcelina Hungria

• USDM is drawing strong interest, often pursued as a standalone goal because protocol digitization saves manual work.
• End-to-end is seen as futuristic. Adoption will be gradual, even with AI.
• External data integration is a major open question, since the demo covers only CRF-collected data.
• Keep the messaging clear that the reference implementation is for illustrating concepts and supporting standards development, not for production.

Cross-cutting themes

• Complex study examples. This connects to Pierre’s point on testing, and Omar is adding it to the Phase 3 roadmap.
• Clearer messaging on API access and on the reference implementation’s non-production status.
• Integration with existing tools and external data.