SS P08 28May2014 Standard Scripts Project 08 Meeting

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Meeting Record

When: 28 May 2014
Place: Teleconference
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: Rebeka, Wei, Ann, Christos, Jane, Nancy, Pierre, Mercy, Simin, Sheryl, Mohammad

  1. White Paper updates


Discussed each white paper's progress:

  • Central Tendency - Done. No update
  • Outlier/shifts - Discussed how often the definition of low and high includes both a threshold and a change value. It appears that it isn't uncommon to have the change component. Therefore, the white paper will include this in scope. Essentially, instead of the 3-panel display, a 2-panel display will be recommended in these cases. The shift table wouldn't be included - too awkward to define and understand.
  • AEs - no update
  • Demo/Disp/Med - Simin went over the comments she received that would also apply to the other white papers.
    • One question was about whether there will be one white paper to cover all topics. We decided to keep our white papers separate at least for now. We can think about combining meds and AEs at some point. Mary will draft a sentence to explain that the white paper is just one of several (for all white papers to include).
    • One question was about whether the white paper includes collection in scope. Collection is only brought up when a particular display is recommended that requires collection in a certain manner. Mary will draft a sentence to address (for all white papers to include).
    • Discussed consistency of how we reference FDA's Reviewer Guidance within the white paper. "Reviewer Guidance" can be the short-cut name used within white papers. Just be consistent within your own white paper.
    • Discussed whether to have a leading zero for p-values. Just be consistent within your own white paper. If and when we get a medical writer, that person can perhaps help us with a style guideline.
  • Liver - no update
  • PK - Done - no update
  • QT Studies - Outline is in progress. 7 people have offered to help write and others have offered to review.

  • Last revision by Jmbodart,10/13/2015