Jan 20 2021 Full group meeting minutes

[mli1]

Attendees

• @jwildfire
• @xni7
• @JimBuchanan
• @mli1
• @DOBrien1
• @MayaGans
• @PHayashi
• @MelvinSMunsaka
• @anzianorj
• @hendricksonb
• Greg Ball
• Michael Colopy
• @sibyllwangxxxx
• @wal615

Agenda/Notes

1. Welcome back note/new member introduction/new meeting schedule note
   • Welcome new members Richard Anziano, Greg Ball and Jerry Nedelman
   • Full team meeting is on 3rd week of each month. 1st week is core team meeting, 2nd week is technical team meeting.
2. 2021 vision /objectives review and high level summary
   • Jeremy shared the 2021 vision and key objectives. See details on the roadmap
   • Technical team is focused to release V2.0 for the first half year.
   • Clinical team is focused on prioritizing future graphic priorities so the full team can work efficiently in the second half year.
   • Small group discussion is probably more efficient when topics are identified.
   • Greg asked progress on AE volcano plot, was discussion points from last year were incorporated? Jim responded that more features have been added and the team is also working on a few things such as FDR-type of correction. Dennis updated the team that the clinical workflow was initiated, however many screenshots of the plot will have to be updated with the new version.
   • Barbara asked about progress of other deliverables such as Renal Explorer. Jim mentioned that it is under review after the draft version was developed. Thoughts and feedback are definitely welcomed.
3. Deployment of GitHub/upcoming tutorial/chart template
   • Team to leverage GitHub for discussion, issue tracking and other purposes. Feel free to initiate new threads.
   • Team can start discussions on safety questions, adding thoughts based on the "open tread: Most important questions" Open Thread - Most Important Questions #479
   • A tutorial is scheduled on Jan 28 2021. Skip suggested to record the tutorial just in case people can't join.
4. Other updates from technical team ( SafetyData, data security, etc.)
   • a new package named safetyData is released on CRAN. This provides easy access to mock ADaM and SDTM dataset for future developing and testing purpose. Thanks to PHUSE's sharing, the dataset is from PHUSE's sample submissions.
   • Data security topic. "data security" and "validation" have come up frequently in the past when we introducing our ISG tools. Starting from last year, the technical team has put together a document to address this question. The tread is on GitHub here. Everyone is encourage to think about different aspects and add your thoughts to this topic.
5. Other updates from anyone
   • Greg mentioned that multiple groups are trying to address the same topic, it would be more productive to have a cohesive conversation with all the groups together. Team agreed with Greg's suggestions. Greg will coordinate among the different groups and schedule inter-working group discussions.

Action Items

• Team to provide input to open tread: Most important questions discussions and initiate small group discussions.
• Team to provide input to "Security documentation and update needed for v2"
• Tutorial of GitHub on Jan 28 2021 and have it recorded.
• Greg Ball to be the coordinator facilitating inter-working group discussion on safety graphics, and inviting ISG members to the conversation.