SS P08 21Mar2017 Standard Scripts Project 08 Meeting

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Meeting Record


When: 21 March 2017
Place: CSS white paper breakout session
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: breakout session attendees
Excused:

Agenda
  1. White Paper Discussions

Minutes

  • Hepatotoxicity white paper - Terry led discussion on various details on the draft. Idea to say safety period instead of treatment period. SMQ tables need overall row. Page 1 of SMQ table can be the rolled-up numbers, new page for each SMQ. Only show if x happens. Suited for interactive tool (with and without PTs)? When to do a listing. Scale back individual study . Integrated - by study display. More clarity on when we have more treatments.
  • TE white paper - Step 1 gather examples. Include recurring events. Hypertension - goes up with a cold med could be a scenario. Next step - Medical scenarios.
  • Lab/vitals/ECGs - discussed initial ideas for update.


    • Last revision by MaryNilsson,06/12/2017