SS 05Apr2017

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Meeting Record

When: 10:00 am - 11:00 am, 05Apr2017
Place: Teleconference
Facilitator: Hanming Tu
Scribe: Hanming Tu
Attendance: Mat, Peter, Jared, Hanming, Mary, Kerry, Alfredo, Gustav

  1. Recap PhUSE US/CSS conference
  2. Plan for PhUSE EU/CSS conference
  3. Review action items - All
  4. Project Update - Project Leads
    1. Update the progress doc in PhUSE teamwork site
  5. Special topics
Discussion Points
  • Recap PhUSE US/CSS conference
  • Plan for PhUSE EU/CSS conference in June 2017
    • Two people (Shafi Chowdhury, Frank Biedermann) will go
    • Nancy B. may go if we could make a case for her to her manager; Mary will reach out to Nancy to find out the details
    • Will schedule a call with potential speakers for WG in the conference
    • 2~3 hours for each WG
    • Poster abstract deadline 4/30/2017
    • Hanming/Wendy will schedule a call next week for people will go to the conference
  • Plan for PhUSE Annual conference EU 10/8/2017
    • Paper Abstract deadline 4/28/2017
    • WG club already in the schedule - prepare material and who will be going.
      • Gustav/Hanming might go
    • Posters: white paper - Mary; Repository - Mat/Hanming; Spotfire - Rebeka
  • Plan for PhUSE 2018
    • Script Discovery and Acquisition (SDA, Rebeka Revis, Alfredo Rojas)
      • Continue reviewing FDA JumpStart scripts -
      • Creating script metadata files for individual script in JumpStart
      • Capturing the codes behind Interactive display of the data in Spotfire or R Shiny
        • a bigger topic related to visualization and need to further discuss
        • It is not clear with project team will tackle on this
    •  Repository Content and Delivery (RCD, Gustav Bernard, Andrew Miskell)
      • Packaging CT scripts including linking to whitepaper, spec and qualification docs
        • use MD to create the linked docs
      • Finishing the shift outlier package including spec and metadata
        • first need to see how long it will take to do one script
        • plan out for the whole package
      • Creating a R group to develop R scripts for CT package
        • There is R group in Lilly and Mary will try to recruit some people
        • R package for executing scripts in Repository - Hanming
        • R programmers in FDA - Mat
        • R execution and sharing environment/metadata of the scripts - Peter
    • Repository Governance and Infrastructure (RGI, Mike Carniello, Hanming Tu)
      • Create a test environment (R and SAS)
      • Expand the YML metadata usage
      • Continue maintaining and administering the repository  
    • Test Data Factory (TDF, Peter Schaefer)
      • Get the current CDISC pilot data sets (SDTM and ADaM) up to current standards
      • Publicize the test data sets
    • Communication, Promotion, Education (CPE, Jared Slain and Wendy Dobson)
      • Develop library of materials that have been presented
      • Create a list of upcoming events and abstract deadlines 
      • Recruit more group and coordinate with Educating for Future - Ian Fleming
    • Analyses and Display White Papers  (ADW, Mary Nilsson)
      • AE White Paper follow‐up tasks
        • Gender‐ and Pediatric‐specific MedDRA lists
        • Process for Grouping MedDRA terms
      • Work on 4 new white papers
        • Hepatotoxicity
        • Questionnaire data
        • Treatment‐emergent definitions
        • Adverse events of special interest
      • Work on version 2 of a couple white papers
        • Demographics/Dispostion/Medications
        • Labs/Vitals/ECGs
Action items
  • PhUSE EU/CSS 6/18~19/2017, The Grange Tower Bridge Hotel, London, UK
    • Mary to reach out to Nancy B to find out what it is needed to suport her for going to PhUSE EU/CSS
    • Gustav to identify support for PhUSE EU/CSS Working Group Breakout Sessions
    • Wendy/Hanming to schedule a call for people going to PhUSE EU/CSS
  • PhUSE EU Annual Conference 10/8~11/2017, Edinburgh, UK
    • Alfredo to develop an abstract on reviewing JumpStart scripts
    • Mary to create a poster on white paper
    • Mat/Hanming to create a poster on repository
    • Rebeka to create a poster on Spotfire
  • Hanming to send an announcement to the WG listbox for the PhUSE US/CSS materials
  • Jared to recruit more people for CPE and create a list of up-coming events
  • Gustav to coordinate the formation of R interest group with the RCD