SEND Implementation User Group Minutes 2019-06-18

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For other minutes, see the SEND Implementation User Group Minutes page.

Logistics

Meetings

Meetings occur every 4 weeks, at 1-2pm EDT.

Attendance

Participant Attended
Troy Smyrnios X
Debra Oetzman
Audrey Walker
Bill Houser
Brett Coupland X
Brian Argo X
Cheryl Sloan
Christy Kubin
Jason Rogers
Jeff Foy
Lou Ann Kramer
Mike Wasko X
Rick Thompson X
Rihab Kordane
Virginie Ora X
Wenxian Wang


Minutes

Forum

Links:

Review Forum


Current Issues

  • Extending CT (here)
    • Follow up completed
  • Question on TERMBW vs VISITDY (here)
    • Answered


Open Issues

  • Extending CT
    • ACTION: next meeting, explore whether to add FAQ item or CT page about this

Review News Page

SEND Implementation News

  • Pinnacle 21 community item added
  • Conformance rules item added

Wiki

  • TS.xpt issue
    • Links/text updated
    • Added bit on TRC and callout to checklist
  • eCTD / TRC links
    • Links/text updated
  • OPEN ITEMS
    • TRC effective?
      • Once TRC is actually published (officially), update any FAQ items mentioning "reject"


General

  • SEND between Organizations SEND between Organizations
    • LEFT OFF AT Can you provide lists of the mappings used to Controlled Terminology?
  • SCOPE EXTENSION: Feedback
    • FDA provides quarterly webinars
    • Tabulating items from feedback
    • Parse FDA webinar
    • Content
      • FDA Webinar
        • will be posting them (but place unknown)
      • FDA fit for use
      • TCG feedback
        • Encouragement/awareness to post freely when receiving this info
      • Sponsor feedback
        • Encouragement/awareness to post freely when receiving this info
    • Just more FAQ items - existing triage process is ok
  • OPEN ITEMS*
    • FDA Webinars
      • where?


Action Items

Responsible Task Timeframe
Troy -- Next meeting

Last revision by Troy.smyrnios, 2019-06-18