SS P08 01May2018 Standard Scripts Project 08 Meeting

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Meeting Record

When: 01 May 2018
Place: Teleconference
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: Lauren, Lori, Simin, Russ, Wei

  1. Comments on Clinical Review Template
  2. PhUSE page on FDA website
  3. Potential action items from CSS
  4. Update on each white paper


  • Clinical Review Template - Extend review period to end of this week
  • PhUSE page now on the FDA website (AE white paper is listed)
  • Potential action items from CSS - journal article, eLearning page on Safety Analytics (will discuss more at next meeting)
  • TEAE definition white paper – small group will start to meet soon
  • Adverse Events of Special Interest white paper – small group has been meeting regularly
  • Version 2 of labs/vitals/ECGs – still hoping to find a writer to help get the update started where we intend to combine the central tendency and outlier/shifts white papers
  • Nhi will be presenting a poster for this project team at the upcoming PhUSE US Connect

    • Last revision by MaryNilsson,05/1/2018