SS P08 16March2015 Standard Scripts Project 08 Meeting

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Meeting Record

When: 16 March 2015 (White Paper Project Breakout session at CSS)
Place: Silver Spring, MD
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: (Did not write the attendees down - going by sign-up sheet) Sascha, Asa, Terry, Mercy, Wei, Frank, Karolyn, Kristen, Nhi, Gustav, Mithun, Julie, Jim, Karin, Steve

  1. Outliers/Shifts White Paper
  2. Questionnaire White Paper


  • Outliers/Shifts White Paper - Went over displays; white paper about to become final (Wei facilitated)
    • Shift tables - want missing post-baseline column added
    • Definition for N needs to be improved
    • OK that CTCAE grade stays out of scope for this white paper - likely to be included in special topics white paper
    • Line of identity in scatterplot - different line style would be better
    • Good that we have displays to cover labs/vitals that meet a threshold plus a delta - sounds like this happens enought to warrant its inclusion
    • We should be more clear that there are other choices for stat methods
  • Questionnaire White Paper (Karin facilitated)
    • Karin gave background
    • Scope will likely include questionnaire data that ends up with a total score
    • Will likely have baseline to endpoint, and by visit
    • SEALD - FDA group on questionnaire data
    • COAs- Clinical Outcome Assessments group at FDA? - Steve gave Karin contacts

  • Last revision by Jmbodart,10/13/2015