SS P08 15Oct2018 Standard Scripts Project 08 Meeting

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Meeting Record


When: 15 October 2018
Place: Teleconference
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: Wendy, Terry, Karin, Mitali, Swarna, Simin, Lothar, Lei, Julie, Wei, perhaps others I may have missed
Excused:

Agenda
  1. A few FYIs
  2. Update on activities

Minutes

  • We have 2 more project teams within our Working Group. There's a potential for overlap with the Output Tips and Considerations white paper. We'll keep an eye on that.
  • We have 2 medical writers - Wolgang and Mitali. Thank you!
  • We presented at the PhUSE FDA Quarterly Forum. See CPE page for presentation if interested. Asking for medical co-authors and broader reviews.
  • Discussed each activity
    • AE white paper follow-up - Gender-specific terms (Hopefully we can make this a priority soon. Mary discuss with Nhi.)
    • AE white paper follow-up - consolidated terms (On hold - waiting to see if FDA and/or CIOMS makes progress)
    • AE white paper follow-up - EU layperson summaries (Mary has action items from last meeting - We don't anticipate this will change our advice in the AE white paper)
    • Medications white paper follow-up - CMDECOD clarity (Mary and Simin follow-up with Marlo)
    • Labs white paper (Wei, Wolfgang, Mary working offline. Will bring ideas to the project team. Hoping to find medical representation. Of note, TAUGs are adding more labs. Might need to say something about this activity.)
    • Vitals white paper (Can work on this after labs.)
    • Events of special interest white paper (Offline meetings occurring. We have borrowed help including from medical. Hoping this will be one we can publish before CSS 2019.)
    • Treatment emergent definitions white paper with Best Practices for Data Collection Instructions project team (Offline meetings occurring. Working on a survey. If asked to participate in a survey, please do so.)
    • Questionnaires white paper (Will start again early next year.)
    • Hepatotoxicity white paper (On hold - We're making other white papers priority. However, if anyone has interest to help Terry, please volunteer.)
    • General output tips and considerations (Karin and Mark meeting offline. When ready, they will bring ideas to the project team. Hoping this will be one we can publish before CSS 2019.)
    • Interactive displays for clinical safety data (Was approved by the Steering Committee, but this probably won't get started until we're done with a couple of the other white papers in progress.)
    • ECGs white paper (Probably won't get started until later next year. We would need medical expertise to move forward.)


    • Last revision by MaryNilsson,10/15/2018