SEND Implementation User Group Minutes 2019-09-10

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


Minutes

Forum

Links:

Review Forum


Current Issues

  • SLENGTH here
    • Previously answered
    • JIRA ticket submitted (Audrey)
  • TSVALNF here
    • Previously answered
  • DART MetaDataVersion conflict here
    • Answered
  • TRTDOS/TRDOSU for fertility animals
    • Contact repro team - Mary Jo - to ask (Brett)


Open Issues

  • TRTDOS/TRDOSU for fertility animals
    • Contact repro team - Mary Jo - to ask (Brett)


Review News Page

SEND Implementation News

  • Bill - webinar - common issues
  • Bill - registry notice on FFU for 3.1

Wiki

  • OPEN ITEMS
    • TRC effective?
      • Once TRC is actually published (officially), update any FAQ items mentioning "reject"
      • 2019-09-10 Update: expected end of year (probably)


General

  • SEND between Organizations SEND between Organizations
    • LEFT OFF AT File format for exchange (samples maybe very helpful in *.xml, *.xls, *.csv, etc.)
  • 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, 2019-09-10