SS 07Sep2016

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Meeting Record

When: 10:00 am - 11:00 am, 07Sep2016
Place: Teleconference
Facilitator: Hanming Tu
Scribe: Wendy
Attendance: Hanming, Wendy, Andrew, Gustav, Jared, Mary, Rebeka, Steve, Mike Man , Rebeka, Gustav,
Excused: Mat, Peter,

  1. Steering committee - Mary
  2. Review action items - All
  3. Project Update - Project Leads
  4. Special topics
    1. CDISC Interchange session/presentation
    2. PhUSE Annual conference session

General discussion

Steering committee update
  • Non- clinical group had presentation in the SC meeting
  • Started script development and shared their concern over vendor relationship.
  • Question: AE whitepaper sent out for review - what defined path would AE whitepaper take to have FDA review?
    • Two sides: how to manage deliverable; how to manage the versions (version control)?
    • Do we get FR notice? Is it due to the content that we do not get it now?
    • Is it possible to get AE whitepaper in SC meeting agenda? - Wendy show the SC review process flow chart.
    • Follow the development process: Deliverables Review Process

  • Data visual analytic meeting on 5/17 will provide some clarity on the topic (Rebeka acting as liaison)
  • CDISC interchange: getting PhUSE particularly script WG more involved in CDISC Interchange - a session for each WG to give updates.
Project Update
  • P01 - SDA: Script discovery and acquisition
    • N/A
  • P02 - RCD: Repository content and delivery (Gustav Bernard; TBD; FDA Liaison: Mat Soukup): Peter gave the updates
    • N/A
  • P03 - RGI: Repository governance and infrastructure: Mike will give update next time
    • N/A
  • P07 - CPE: Communication, Promotion and Education (Jared Slain and Wendy Dobson)
    • Jared and Wendy had a meeting to discuss the goals
    • Jared will present the paper in annual conference
    • Updated the the documents on the wiki
    • Build a wiki team for the project
    • will participate in up-coming webinars
    • Dedicated communications for WGs
    • Updated wiki pages
  • P08 - ADW: Analysis and Display White papers (Mary Nilsson)
    • N/A
  • P09 - TDF: Test Dataset Factory (Peter Schaefer; TBD)
    • Started recruiting members: Nancy Brucken
    • Have done a little work and will put on wiki page
    • Send a message to the whole WG
Special topics
  • Options for script development - Peter
    • Still need feedback on using Interns: will need to bring it to the SC in PhUSE; Chris will talk it in PhUSE annual conference F2F.
    • Discussion on the competition between PhUSE and vendors for the same solutions
    • CDISC Interchange session/presentation: 9/26~30/2016
  • CDISC Interchange session/presentation
    • Slides due on 9/12 - Mary will draft slides
  • PhUSE Annual conference session - scriptathon
    • Gustav will organize the content: Adie and Frank
    • Jared will be there.
    • Hanming will try to be there

Follow up

Action Items
  • FDA plan for releasing JumpStart scripts - Steve/Mat
    • Meeting every month and will bring it up again
    • We got 7 scripts. Are we getting more scripts from FDA?
    • What scripts that FDA are developing? - Steve/Mat to find out
  • Plan for a webinar for JumpStart scripts in Fall 2016 - Wendy (WD)
    • 10 minutes presentation in the webinar to be arranged 16th of November; We will not do 1 hour webinar.
    • HT and MN to send WD details for communications & registration - we do not need this since we will not do 1 hour webinar
    • 21 Sept webinar: Peter will present his project.
  • P. Schaefer to send details to WD for communications to Script Team via listbox asking for volunteers
  • Roadmap for long term development - Mary/Hanming
Next Meeting

Time: 10:00 am - 11:00 am (Wednesday)
We will conduct this meeting once per month.

Agenda for next meeting: Next meeting: TBD

Last revision by Htu,09/7/2016