Phase 2 Scope Changes 2026-06

[swhume]

After a 2026-06-08 meeting with the 360i Executive Sponsors, we've agreed to several refinements to the existing Phase 2 Scope:

1. Change to the architecture diagram
   • Remove the refinement pipeline from the diagram, as we will only include replacing PLACEHOLDERs in the DDS
   • Refinement pipelines will be considered extensions to the published architecture
   • The overall goal remains the same: maintain all the metadata used to generate content in the DDS
2. DDS as a deliverable
   • Interested in publishing a draft by the EOY
   • Create a plan for releasing DDS v1.0
   • Create a plan for what we can showcase at the US Interchange
3. AC team will provide content for us to work from to generate ADaM Define-XML
   • We do not need to get involved directly in the modeling effort
   • Currently, the AC team is planning to generate DDS content from the AC models
   • Timelines for getting that content are not yet known
4. Trial Design and Alternative Sources FTs are no longer in scope for Phase 2
   • As a team, we will not spend time on these during Phase 2
   • They remain of interest, so for example, after completing our main deliverables, I will work on alternative metadata loaders
5. Because it is a support function, DevOps will not be listed as a Feature Team
   - Overall, we have reduced the number of active FTs for Phase 2
   - New FT list (4): Define-XML, CRF, DTA-to-SDTM, DDS Model