2018 CSS Discussion Continuation

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When: 09:00 EST, 28MAR2018
Place: GoTo Meeting
Facilitator: Wendy Dobson and Jared Slain
Scribe: Jared Slain
Attendance: Wendy Dobson, Jared Slain, Mary Nilsson, Mat Soukup, Susan Duke
Agenda: 2018 CSS Discussion Continuation

Update on CSS Breakout - review WD notes

  • Wendy typed up the minutes that she recorded at CSS, and they are on the wiki (link on CPE page in minutes section)

PhUSE Tube

  • Mary to see if Charles Beasley would present for the p-values video
  • Another video on pooling data across multiple studies might be done before p-values

Clinical Review Template (CRT)

  • Mary considers the incorporation of feedback from the Whitepapers team into the FDA's CRT to be the most important action item from CSS
  • Mary will continue to work with Nhi on this topic

Communication with other Working Groups

  • Susan observed that other WGs do not think about communication at the same time as deliverables are defined.
  • Mary indicated that our WG is special in that we have the CPE team

Whitepapers Discussion

  • White Paper on Demographics has been published
  • Still an open question of how we get the FDA to somehow link to and publicize the whitepapers
  • Still need to create a page to pull together all WG deliverables
  • Jared brought up an idea of registering a new domain name (e.g., SafetyAnalytics.org) where links from this group's deliverables, as well as possibly deliverables from other organizations, can all be maintained in a single, search-engine friendly location.

Action Items

  • Mary - Work with Nhi to have whitepaper feedback incorporated into CRT; Review/Edit p-values slide deck for video; Contact Charles Beasley to see if he will be p-values video presenter
  • Jared - Write up proposal for new website; continue work on poster for annual conference
  • Wendy - Send out survey for biweekly meeting schedule; continue to work on wiki (done)
  • Wendy to send call for writers on PhUSE Social Platforms for Version 2 White Paper on Vital Signs, Labs etc (done)
  • Qais Hatim (FDA) volunteered to help with Journal Article Publishing. Team to reach out when applicable.
  • Analysis & Display White Paper project make look to do re-branding. Safety Analysis needs to be in title. Team to think of suggestions
  • CSS Cross Collaboration meeting with Data Visualisation Team - Mary to type up minutes
  • Clinical Trials Template - Distribute to team for comment (done)

Last revision by WendyDobson,04/4/2018