SS P08 15Sept2017 Standard Scripts Project 08 Meeting

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Meeting Record


When: 15 September 2017
Place: Teleconference
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: Lauren, Lisa, Terry, Russ, Wei, Cathy, Karin, Mohammad, Nhi, Mercy, Jared, Julie, Aiming, others I may have missed
Excused:

Agenda
  1. Medication tables
  2. Update on collaborations
  3. Liver-related question


Minutes

  • If analyze by ingredient in medication tables, what would be needed. May need an ADaM dataset with 1 record per ingredient. Need to be prepared for summarizing by ATC.
  • Mary gave an update on collaboration discussions (ASA Safety Monitoring Group, ASA programming group)
  • Discussed whether summarizing 3x baseline for liver is becoming more standard. Mentioned in a guidance. We need to at least address this in the liver white paper - either recommend it or explain why not recommended.
    • Last revision by MaryNilsson,12/15/2017