SS P08 16June2015 Standard Scripts Project 08 Meeting

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Meeting Record

When: 16 June 2015
Place: Teleconference
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: Simin, Wei, John, Nhi, Sheryl, Nancy (post-meeting)

  1. White Paper Updates


  • 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. We will also put it in the PhUSE template format. (Post-meeting notes with Nancy - We should target tweaks for August, ADaM specifications for September-ish. Out for broad review October-ish. Nancy will work with ADaM group on desired format.)
    • Outliers/shifts - Working on finalizing. Currently with the editor. Next to Steering Committee for approval. We would then need to discuss how to get the word out. (Network with Nhi, Mat, and our Communications Project Team.)
    • AE - Working on draft 2 for broad review. Hopefully within a month. Nhi has followed-up with Japan representative on relatedness topic. The Japan representative is more involved with the post-marketing side, but she will ask her pre-marketing colleagues for input.
    • Demog/Disp/Med - Simin working on version 2.0. Version 2.0 will also need ADaM specifications and new PhUSE template - can wait until these are done for the other white papers. Nhi mentioned that there is some activity within the FDA on a "demographic map". Nhi will give us an update on if there's an overlap in scope.
    • Hepatotoxicity - Terry not in attendance. Working toward draft 1 for broad review.
    • QT - working toward draft 1 for broad review. Small group has been asked for comments by end of June so progress is being made.
    • Questionnaire - no update

  • Last revision by MaryNilsson,06/16/2015