SS P08 06April2016 Standard Scripts Project 08 Meeting

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Meeting Record


When: 06 April 2016
Place: Teleconference
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: Russ, Simin, Nancy, Terry, Wendy, Nhi, Mercy, Wei, others I may have missed
Excused:

Agenda
  1. Summary of CSS white paper breakout sessions
  2. Develop action items related to CSS discussions


Minutes

  • Went over CSS white paper minutes
  • Discussed action items:
    • To develop ADaM for the C-SSRS, need to address copyright. Nancy will follow-up.
    • Wei/Mary - Forward Craig Mallinkrodt's contact information to Nancy and Karin. He might be a good resource for the missing data topic. (There's a Missing Data Working Group that might have a lot of things to use as a reference.)
    • The DILI conference slides should be available publicly. Those active in the hepatotoxicity white paper should review these.
    • Mercy has action items related to being the liaison with the Script Repository group. Future agenda topic for our project team.
    • Consolidated terms - Next step is to meet with the FDA MedDRA SME.
    • Nhi mentioned that the FDA is working on updating ISS guidance. Nhi will begin networking.


    • Last revision by MaryNilsson,04/11/2016