SS P08 14Sept2018 Standard Scripts Project 08 Meeting

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Meeting Record

When: 14 September 2018
Place: Teleconference
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: Simin, Wei, Terry, Nancy

  1. White paper updates
  2. EU layperson summaries


  • We had an issue with getting the meeting started. Mary will check future meetings to make sure a PhUSE rep is available or the meeting has her call-in. So, it was a short meeting, and some people may have tried but went on to other tasks.
  • EU layperson summaries. There's a guidance that suggests summaries that we don't have as part of our normal recommendations in the AE white paper. They have TEAEs, SAEs, AEs leading to disc, all sub-setted with those considered related by the investigator. Our ADW project team might meet with the EU layperson summary expert group, and/or the PhUSE Transparency project team. It would be nice to get an understanding of all the different repositories (CT Registry, EUDRACT, EU layperson, etc), and what is recommended. Note: Relatedness collection is not standardized.
  • White paper updates
    • vitals/labs version 2 is starting and we have a medical writer. We think ECGs should be its own white paper. Perhaps vitals should be its own as well. **Medications white paper - Preferred term actually has 2 choices - one with salt base, one not. Mary will follow-up with Marlo. Pertains to CMDECOD. We might want to update the white paper with this additional information, not sure.
    • TE white paper - Currently a joint effort with the Best Practices for Data Collection project team. First version will represent current practices. Later versions to have recommendations.
    • AESI white paper is moving along
    • Liver and Questionnaire white papers seem to have stalled
    • Output white paper - Mary to follow-up with possible co-authors to Karin
    • Interactive displays - Mary check that it went to Steering Committee.
    • Last revision by MaryNilsson,09/24/2018