SS 07Dec2016

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Meeting Record

When: 10:00 am - 11:00 am, 07Dec2016
Place: Teleconference
Facilitator: Hanming Tu
Scribe: Wendy
Attendance: Wendy, Hanming, Mat, Jared, Mary, Mike Man, Steve , and Rebeka
Excused: Peter, Gustav, Andy

  1. Steering committee - Mary
  2. Review action items - All
  3. Project Update - Project Leads
    1. Update the progress doc in PhUSE teamwork site
  4. Special topics
    1. November PhUSE webinar
    2. Feedback
      1. CDISC Interchange feedback
      2. PhUSE Annual conference feedback
    3. Plan for PhUSE/CSS March conference

General discussion

Steering committee update
  • Rebeka: get status from visualization project in emergence tech WG
  • Best practice for data collection and instruction project: in PhUSE approval process and identified one lead
  • Process Flow chart for whitepaper review
  • Monthly project update for each project:
Project Update
  • P01 - SDA: Script discovery and acquisition
    • Wait for Ted Peterson to provide update: working on creating a package for the 7 scripts and the expected time to complete is by the end of this year.
    • Wait for Mary to get gap analysis
  • P02 - RCD: Repository content and delivery (Gustav Bernard; Andy; FDA Liaison: Mat Soukup):
    • Help with scripathon in annual conference
    • Need to retain volunteers to work on the scripts
    • Will talk to Frank on demonstrating one script during scriptathon.
  • P03 - RGI: Repository governance and infrastructure: Mike will give update next time
    • Upload CDISC SDTM and ADaM data set: Rebeka to give Hanming link and Hanming will upload
    • All the SDTM and ADaM data sets were uploaded
  • P07 - CPE: Communication, Promotion and Education (Jared Slain and Wendy Dobson)
    • Updated the the documents on the wiki
    • Build a wiki team for the project
    • will participate in up-coming webinars
    • Dedicated communications for WGs
  • P08 - ADW: Analysis and Display White papers (Mary Nilsson)
    • Focus on AE whitepaper
    • Discussed MEDDRA issue
  • P09 - TDF: Test Dataset Factory (Peter Schaefer; TBD)
    • We have now finally scheduled a real kick off meeting for next week (another person joined the group, so we are four now. Mary, I think you mentioned that you might have someone who would be interested, right?: Ted Peterson and Tuan Nguyen.).
    • There is also a meeting to be scheduled with Scott and Chris Decker about my proposal to CDISC to make the TDF project the core of a broader CDISC effort to provide what I would call a “next generation CDISC Pilot” – it seems like there is some need for clarification.

So, here we go with the summary and status report: - We discussed the option to work on an update of the CDISC Pilot data and agreed that it would be a good thing to do. - The benefit that we saw include: o It is easier / less complex than the proposal to re-create raw data and extract CDISC data for the JumpStart scripts. So, this seems to be achievable. o It is straight forward to distribute the work, pretty much everyone can work on a piece, so it would be possible to make good progress o We see an immediate benefit for users as a ready to use set of data would be available - The downside is that the result would still be a static set of data with the limitation that the CDISC Pilot has. Bit at least, it would be up-to-date. So here is the plan and some action items before the next meeting: - The plan of attack is pretty simple: o First round:  Run each dataset of the CDISC Pilot through Pinnacle 21 Community Edition Validator  Fix the issues that we can fix, document issues that we can’t fix (if there are any)  Add missing datasets that would be required by the newer version of the CDISC standards  Wrap everything up and write appropriate documentation - We need to get the current CDISC Pilot dataset that we want to use as our source data - We need to determine the target version of the CDISC standards (proposals are welcome) - Bring thoughts about how we can work together to the next meeting: Most importantly, how do we share data? Can we all use some sharing utility – options are Dropbox, Github, Wiki, other proposals are welcome)

I will also update our Wiki page as soon as I find the time. It is at and has not been updated for a while.

  • CDISC Interchange
    • Steve: it went well and accomplished what we planned
    • PhUSE and CDISC work together
  • PhUSE Annual Conference
    • Scriptathon: had 42 registered but only 8 shown up in the event
    • CS discussion club: well attended and got 5 new people interested
    • Jared presentation: no many attended due to the session in the last day; Lillian was there and facilitated question
  • PhUSE/CSS conference
    • Registration was open on 11/1/2016
    • Workshop: JumpStart script, Spotfire template
    • Scriptathon: should we continue or run it like Single Day Event (SDE)? This is related to statistical computing environment (SCE). There is no established SCE for it.
    • Talk to Frank Senk on Scriptathon

Follow up

Action Items
  • Plan for a webinar on 11/16/2016
    • Hanming to prepare the draft and send out
    • Project lead to send updated status back to Hanming
  • CPE project
    • Jared/Wendy to update the presentations
    • Jared/Wendy to add up-coming events
  • Roadmap for long term development - Mary/Hanming
  • We need to coordinate with American Statistical Association (ASA/SSPA)
  • Set up next meetings in 2017 - Wendy
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,12/6/2016