March 13th 2018 Minutes

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Attendees: Eric, Hari, Heather, Mike, Mellisa, Roxane, Elena, Jasmine, Anupama, Bharath

Apologies: Zach, Sharon


  • Welcome new member Anupama Sheoran
    • Lead Stat analysis with Bayer

CSS review

  • 5 new members joined Data Visualisation
  • FDA Session was very interesting and gave a good insight into what they are doing and the reports they are using
  • Not all submissions are accepted
  • 5-6 Months for review

Wrap up at CSS

  • Best Practices for Interactive Anaylyses
    • Proof of concept collaboration with OSI listing
    • Look into the hosting options with a third party and how will we deliver this to the FDA
    • Team will do an analyses of the third party options and work with the FDA to deliver that
  • Use of Data Visualisations for Subject Level Data Review
    • Displayed a poster and had some feedback
    • There is a lot more detail which didn't make the poster, this will be put into a White Paper
    • We want to look at what functionalities are useful
    • Looking to do a second survey focusing on what new features would be helpful
  • Use of Data Visualisation for Data Anomaly Detection
    • Identified what questions we want answered from the speakers during the sessions we are holding
    • Looking to expand collaboration with ASA
    • Next steps with the presentations are to prep the speakers with the content

Continuing our collaborative work - Potential collaborative groups

  • A number of groups at FDA
    • Data Integrity Advisory Board
    • Clinical Endpoints Working Group
    • PK/PD Data Anomlay Working Group (DWAG)
  • PhUSE Working Groups
    • Standard Anlyses and Code Sharing
    • Machine Learning/AL
    • Transparency - Narratives - Potential collaboration
  • Industry Groups
    • ASA Safety Monitoring WG - Susan Duke
    • CTTI
    • Transcelerate
    • CTSpedia


  • Susan Duke from FDA is looking for programers to take part in her WG if you're interested please reach out to Mike/Mellisa/Lauren