SS P08 05May2015 Standard Scripts Project 08 Meeting

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Meeting Record

When: 05 May 2015
Place: Teleconference
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: Ann, Terry, Nicolas, Nhi, Wei, Simin, John, Frank

  1. Wiki has been updated
  2. Need help with CSS minutes
  3. White Paper Updates


  • Mary showed the project team the updates to the wiki - I should be caught up with minutes
  • White paper leads can review CSS minutes (16March, 17March for accuracy and any updates)
  • Discussed medical writing support (John) - Any new white paper - involve him early. For white papers moving from version 1.0 to 2.0 - might want to reformat first (with new PhUSE template, etc) before making updates.
  • Nhi and Mary to work with Mat - When a white paper is ready for broad review, who from FDA to request a review. (Sounds like Mat has some ideas.)
  • White Paper updates
    • Central Tendency - Version 2.0 to include ADaM specifications is a goal for the year. If we have additional tweaks, we can make those. This might make us out-of-sync with the code that has been developed using version 1.0. That should be OK. Mary will bring this up with the scripts project team.
    • Outliers/shifts - Working on finalizing. John reviewed. Wei/John/Mary to review off-line to decide how much to change at this point and if/when/who on moving to the PhUSE template.
    • AE - Targeting June for draft 2 for broad review. Nhi will follow-up with Japan representative on relatedness topic.
    • Demog/Disp/Med - Simin working on version 2.0. She'll focus on the things that were out-of-scope for version 1.0. Version 2.0 will also need ADaM specifications and new PhUSE template - can wait until these are done for the other white papers.
    • Hepatotoxicity - May 22nd goal for draft 1 for broad review. When ready, give to Dirk, Mary to send to Steering Committee for approval.
    • QT - working toward draft 1 for broad review
    • Questionnaire - no update

  • Last revision by Jmbodart,10/13/2015