SS P08 25Feb2015 Standard Scripts Project 08 Meeting

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Meeting Record

When: 25 February 2015
Place: Teleconference
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: Rebeka, Wei, Christos, Mercy, Mohammad, Terry, Karin, Ann, Karolyn

  1. CSS breakout session preparation


  • At breakout session, will discuss adjusted percentages (Wei to facilitate), questions on AE white paper (time after last dose, time to events, etc.), Karin to give background/sample displays on questionnarie white paper, Terry to some hepato displays
  • Discussed collection of adverse events leading to discontinuation - There is variability. Some studies instruct sites to pick one. Other studies allow ability to pick more than one. It appears most companies do not collect this on disposition, only AE page.
  • Mercy will send Karin sample displays for questionnaire data. Scope is general data. If a display is unique to a particular questionnaire, that would be in CDISC document.
  • White paper plans
    • Outliers/shifts - finalize after CSS
    • AE - Draft 2 after CSS
    • Hepatotoxicity - Draft to white paper project shortly after CSS
    • TQT - Draft to white paper project within a few weeks
    • Questionnaire - gather initial ideas
  • Last revision by Jmbodart,10/13/2015