SS 05Dec2018

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Meeting Record

When: 10:00 am - 11:00 am, 05Dec2018
Place: Teleconference
Facilitator: Hanming/Wendy
Scribe: Hanming/Wendy
Attendance: Mary, Jared, Hanming, Wendy, Maria, Ninan, Peter, Mark

  • Recap All Hands meeting
    • We had 16 attendees; We have over 60 in our listbox
    • We need to attract more attendees and we need to send out to all the listbox groups
    • Plan to do one after US Connect and before the earlier bird registration of CSS
  • Steering committee update
    • New working lead jointed
    • Finalize roles and responsibilities of PhUSE directors and leads
    • Design thinking: case study - interactive visuals
    • Whitepaper review: some of them may not need to have public review such as one of Whitepaper at SACS
  • New Topics
    • Repository: only store final data sets or allow for other data sets?
      • project deliverable -> steering committee review and approval -> public review

-> revision? -> (steering committee approval again?) -> publish?

    • Workshop at CSS:
      • It is official that we will host a workshop.
      • It will be more focused on whitepaper, safety and education.
  • Up-coming events
    • PhUSE US Connect 2019, Baltimore
 Data-driven Science
 February 24th - 27th 2019
    • PhUSE/CSS: June 2019
 Silver Spring, Maryland
 June, 9th - 11th 2019
    • DIA in June 23~27, 2019
 San Diego Convention Center 
 111 W Harbor Drive 
 San Diego, CA 92101
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      • Draft guidance on managing repositories [on-going]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 (there is a new leader: Jean-Marc)
  • Scripts used for part of Jumpstart service - Hanming/Mary
  • GPP - sub-project: Macro development? - Mark/Maria to update wiki page
  • Plan All-hands meeting after US connect (April 2019?) - Wendy/Mary/Hanming