Team Meeting 2026-04-16

[MelissaQTanner]

Agenda Items

Item	Description	Owner	Time
1. Continued Volunteer Onboarding	Welcome this week's newcomers, Volunteer Onboarding Notes in GitHub Discussions	@MelissaQTanner	5 min
2. Request: Accept GitHub repo invitation	Project access to be provided after this step	@MelissaQTanner	5 min
3. Discussion: DSS "VLM Target": for non-Findings datasets	Decide inclusion & follow-up to define Parameters	@dostiep	15 min
4. Discussion: Define-xml Generation tasks to complete prior to EU interchange	Review and assign as needed	@swhume @dostiep	15 min
5. Call for Volunteer: README	GitHub README needs technical update #75	@MelissaQTanner	5 min
6. Discussion: Dataset Conversion Scope	Decide on inclusion/exclusion of Raw-to-SDTM-to-ADaM dataset generation in Phase 2. Identify content owner and plan debrief on Phase 1 work.	@swhume @lexjansen	15 min
As time permits:
7. Identify Walk-in Topics	AOB	All	5 min
8. Discussion: Sub-teams	Consider feature focused sub-teams	All	10min

[sherry-chou]

Status for issue 4: based on Pierre's updated codes, added a few more P21E issues based on resulting define.json/xml:
#77
#78
#79
#80

I also saw that the new create_define_json.py now contains outputs for PLACEHOLDERS? The corresponding README.md also needs to be updated to reflect this?

[MelissaQTanner]

Meeting Notes:

All Team Meeting Recordings located here: https://cdisc.sharepoint.com/:f:/r/sites/360i/Team%20Documents/360i%20Phase%202/WG2-Automated%20eCRF,%20Define,%20and%20Dataset%20Generation/WG2%20-%20Team%20Meeting%20Recordings?csf=1&web=1&e=SuvZpH

Continued Volunteer Onboarding

• Onboarding resources provided in a Discussion within the Repo. Volunteer Onboarding Notes #69 (comment)

Accept GitHub repo invitation

• For those that have provided your GitHub username, please accept the invitation from GitHub if you have not already done so. For those of you that have not yet provided your GitHub username, please send to Melissa Tanner.
• Once you accept the GitHub invitation, access to the project (where the Kanban is available) will be granted.

DSS “VLM Target” for non-Findings datasets

• Team provided feedback that while not typically included there is no restriction in including non-Finding datasets
• A workflow will be developed and assessed for complexity/ease of use regarding user-added VLM
• User added VLM will likely be addressed after the EU Interchange
• Issues/Tasks to be added to the backlog – Sam, Pierre

Define-xml Generation tasks due by EU interchange

• Tasks 77-80 are in progress
• Pierre reports problem with USDM pilot study data and requests support for updating file to address misalignment with updated standards
• Decision was made that update to USDM pilot study is not required by EU interchange but will be needed for longer-term project goals
• Topic of the need for USDM change control was discussed. Darren will follow-up on this topic and provide guidance on which files to use and what changes can be made

README

• Nicolas has volunteered to work on an updated draft of GitHub
• README update goal to align with Phase 2 scope and provide additional guidance for new volunteers.
• README adds technical details on how to get started and run the current codebase.

Dataset Conversion Scope

• Team discussed inclusion/exclusion of Raw-to-SDTM dataset scope in Phase 2. Team was not opposed. Anthony mentioned that new team volunteer, Chaitanya, would be a good resource for this work.
• Sam to provide a high-level overview of the intended scope for review by Chaitanya and the team.
• Post-meeting note: In review of this scope with leadership, the decision was made that if the scope is added for Phase 2 it will not be Raw-to-SDTM but rather a more refined scope of DTA to SDTM.

Items for next meeting:

• Team to consider alignment to these potential subgroups: 1) Define generation, 2) eCRF generation, 3) Trial design datasets, 4) DTA to SDTM generation, 5) SDTM to ADaM dataset generation, 6) Alternative sources (e.g. spreadsheets - to support existing ways of working)