SS P08 27Nov2018 Standard Scripts Project 08 Meeting

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Meeting Record


When: 27 November 2018
Place: Teleconference
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: Lauren, Terry, Swarna, Wolfgang, Wei, perhaps others I may have missed
Excused:

Agenda
  1. A few FYIs
  2. Update on activities

Minutes

  • CSS 2019 - There will be a Safety Analytics Workshop that our project team (with the CPE project team) needs to prepare for
  • DIA Annual Meeting - There is a planned presentation about our project team. The DIA-ASA group will be presenting their liver package that has potential overlap with liver white paper.
  • Safety Topics of Interest white paper - it's moving along
  • Labs white paper - it's moving along
  • Interactive displays for clinical safety data - Discussed primary messages: an interactive tool needs easy navigation, the flow of the tool should prevent bad analysis practices; need to address the concern that delays could be introduced by having sponsors/reviewers going off for months looking at data in more ways than necessary. (Post meeting notes: Create a flow chart of the thought process. For example, start with an AE table, then might want to look at individual patient data for a PT, or look at onset/duration, or lab changes over time, then individual patient data.)
    • Last revision by MaryNilsson,01/8/2019