SS P08 23Feb2016 Standard Scripts Project 08 Meeting

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Meeting Record

When: 23 Feb 2016
Place: Teleconference
Facilitator: Mary Nilsson
Scribe: Mary Nilsson
Attendance: Rebeka, Nhi, Terry, Wei, Nancy, Blisse, Xiaoping, Mercy, Karin, others I may have missed

  1. Upcoming March CSS and updates
  2. AE topics


  • During CSS, focus will be on AE, hepatotoxicity, and questionnaire white papers.
  • PhUSE Webinar tomorrow - Provide an easy opportunity to see what's going on with the other working groups.
  • AE white paper: confirmed that oncology tends to collect severity using 5 point scale, Non-oncology uses mild, moderate, severe. Discussed relatedness assessed by the investigator. It appears we agree that we don't generally need a summary despite the fact that most of us normally create such a summary. I has been noted that some internal company people have found a summary useful for focusing the AE discussion, and Mercy believes her company has experience where they have been specifically asked for such a summary by a regulator, but it appears to not be widespread. We discussed if it should even be collected. Nancy determined that it's listed as "Expected" in CDISC. She will follow-up with SDTM contacts to see if she can gain insight as to why it was considered expected. (From CIOMS, it appears it might be helpful for individual case review, but perhaps it could be collected only for SAEs?) Mercy will follow-up to see if she can get more specific information for when they were specifically asked for summaries of investigator relatedness.
    • Last revision by MaryNilsson,02/23/2016