SS 14Nov2018

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Meeting Record

When: 10:00 am - 11:00 am, 14Nov2018
Place: Teleconference
Facilitator: Hanming/Wendy
Scribe: Hanming/Wendy
Attendance: Mat, Jared, Mary, Hanming, Peter, Wendy, Steve, Jane M., Hal

  • All Hands meeting
  • New Projects
    • Best practice for quality control and validation
    • GPP
  • Steering committee
  • Up-coming events
    • PhUSE US Connect 2019, Baltimore, Feb 2019;
All Hands meeting
New Projects
    • Jane - best practice for quality control and validation: finalized the membership before the end of year
    • GPP: - gaining membership
Steering committee
  • Peter: comments were provided from SC review; will have it on the to-do list
  • Hanming: received comments and incorporate the comments and then go for public comments; will have it for public review
  • Project update for SC by the end of November
Pass and Up-coming events
    • PhUSE EU 2018: Nov 2018
      • Working group into displayed during the poster session
    • PhUSE US Connect 2019, Baltimore, Feb 2019;
      • Project description
    • PhUSE/CSS: June 2019
      • Description of Workshop for CSS
Action items for 2018/2019
  • SACS Working Group as a whole
    • High priorities
      • Finalize project team restructure [done] and project leads for restructured project teams [on-going]
      • Update wiki with new structure and new projects [done]
    • Medium priorities
      • Have more full WG meetings/communications [done]
      • Address challenges with changing the culture from working in silos to sharing and co-developing and identify actionable items [on-going]
      • Turn outreach meetings into actionable items: [on-going]
      • Additional networking with Visualizations project? [on-going]
      • Additional networking with TransCelerate/others? [on-going]
    • Low priorities?
  • Repository-related project teams
    • High priorities
      • Finalize meta-data plan [done]
      • Draft guidance on managing repositories [on-going]
      • Improve front-end for repository [on-going, with CPE]
    • Medium priorities
      • Work with others on co-development of interactive tools?
      • Additional scripts from FDA?
      • Keep wiki up-to-date
      • Determine next targets for script development
  • Analysis and Display white papers
    • High priorities
      • Comments on Clinical Review Template (in progress) [done]
      • Additional announcements on latest white paper [done]
      • Create summary paragraph that can be used [on-going]
      • Continue with white papers in progress [on-going]
      • At least one final by end of PhUSE year [on-going]
    • Medium priorities
      • Improve collaborations with ASA/DIA
      • Work with CPE project on improving visibility, especially with Safety Analytics
      • Keep wiki up-to-date
    • Low priorities
      • Work with CPE project on improving review process
      • AE white paper follow-ups – Consolidated terms, gender/pediatric events
  • Communications, Promotion, Education
    • High priorities
      • Help other projects with communication around their final deliverable [on-going]
      • Improve navigation from PhUSE home page [on-going]
      • More presentations/posters at multiple conferences [on-going]
      • Keep wiki up-to-date [done]
      • Key educational video clips (define high vs medium) [on-going]
      • Links from FDA sites/documents/training [on-going]
      • Write a journal article (need to define focus) [on-going]
    • Medium priorities
      • Develop thorough/targeted communication plan
      • Improve index ranking
      • Create a Safety Analytics site (likely with ASA/DIA)
      • Safety Analytics Workshop - record and post (likely with ASA/DIA)
      • Crowd-source educational library (FDA/sponsors share what they have?) (likely with ASA/DIA)
      • Additional education videos (define high vs medium)
      • Work with ADW project on any additional ideas to improve visibility, especially with Safety Analytics
      • Survey on whitepaper use
    • Low priorities
      • Work with ADW project on improving review process
      • Write additional journal articles
  • Test Data Factory
    • High priorities
      • Finish and publish updated ADaM datasets [on-going]
      • Create the capability to generate simulated test datasets [on-going]
    • Medium priorities
      • Determine next deliverables
      • Work with CPE project for additional communications on availability of updated SDTM pilot data
      • Work with CDISC on putting these updated datasets in CDISC?
      • Keep wiki up-to-date
    • Low priorities
      • Identify/collaborate with other groups with potential overlap
      • Identify additional real study de-identified datasets to be used as test datasets
  • Best practice for quality control and validation
Action items
  • Contact Data transparency working group - Mary
  • Consolidate the meeting for the four tasks under Repository - Wendy/Hanming [done]
  • Reach out for full WG meeting - Wendy/Hanming - (November 29)
  • Scripts used for part of Jumpstart service - Hanming/Mary
  • Search for updated clinical review template from FDA - Mary [done, may not get posted]
  • Find old slide deck - Hanming/Mary
  • New template for slides - Wendy
  • Prepare slides for All hands meeting - All project leads
  • Provide update and timelines to SC by each project lead by the end of November