SS 01Aug2018

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Meeting Record


When: 10:00 am - 11:00 am, 01Aug2018
Place: Teleconference
Facilitator: Hanming/Lauren
Scribe: Mary/Wendy
Attendance: Jared, Peter, Alfredo, Lauren, Hanming
Excused: Steve

Agenda
  • Recap PhUSE Connect 2018
  • Steering committee
  • US Connect 2019, Baltimore, Feb 2019;
    • Registration and abstract submission, July 2, 2018;
PhUSE Conferences
  • PhUSE EU 2018: Nov 2018
  • PhUSE US Connect 2019: Feb 2019
  • PhUSE/CSS: June 2019
  • CDISC InterChange: October 12, 2018
Action items for 2018/2019
  • SACS Working Group as a whole
    • High priorities
      • Finalize project team restructure and project leads for restructured project teams
      • Update wiki with new structure and new projects
    • Medium priorities
      • Have more full WG meetings/communications
      • Address challenges with changing the culture from working in silos to sharing and co-developing and identify actionable items
      • Turn outreach meetings into actionable items:
      • Additional networking with Visualizations project?
      • Additional networking with TransCelerate/others?
    • Low priorities?
  • Repository-related project teams
    • High priorities
      • Finalize meta-data plan
      • Draft guidance on managing repositories
      • Improve front-end for repository
    • 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)
      • Additional announcements on latest white paper
      • Create summary paragraph that can be used
      • Continue with white papers in progress
      • At least one final by end of PhUSE year
    • 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 deliverables
      • Improve navigation from PhUSE home page
      • More presentations/posters at multiple conferences
      • Keep wiki up-to-date
      • Key educational video clips (define high vs medium)
      • Links from FDA sites/documents/training
      • Write a journal article (need to define focus)
    • 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
    • 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
      • Create the capability to generate simulated test datasets
    • 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
Steering Committee
  • PhUSE webinar: 08/01/2018 10 am
PhUSE Connect
  • Attendees: Wendy, Hanming, Peter, Jared, Gustav, Andy
  • Possible: Steve
  • Final poster due on May 4th
PhUSE EU 2018
  • Attendees: Wendy
  • Deadline: paper 4/20/2018; early bird 7/27/2018
  • Hanming submitted a paper abstract
Wendy report on PhUSE initiatives
  • PhUSE Project Tracker
  • FDA participation: FDA quarterly meeting and topics discussed
Action items
  • Create restructured project slides - Hanming [done]
  • Update wiki page with new structure - Wendy
  • Consolidate the meeting for the four tasks under Repository - Wendy/Hanming
  • Reach out for full WG meeting - Wendy/Hanming - (September?)
  • Scripts used for part of Jumpstart service - Hanming/Mary
  • Search for updated clinical review template - Mary
  • Prepare Sep 2018 meeting with FDA - Mary/Hanming (get update from Mary in next meeting)