SEND Implementation User Group Minutes 2019-07-16

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



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


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




Review Forum

Current Issues

  • Define casing on origin (here)
    • Define 2.1 not on standards catalog but out there
    • 3.1 lists some origins but refers to define standard
    • Define lists some but refers to CT
    • CT doesn't have anything yet
    • Answered
    • ACTION: Mike - create JIRA ticket for removing/refining SENDIG examples/text around origin
    • ACTION: Mike - broach origin CT with CT team
  • Ophthalmoscopic quantitative
  • Question on quantitative ophthalmic obs (here)
    • Answered

Open Issues

  • Extending CT
    • Added/updated question on FAQ
    • ACTION: next meeting, FAQ page (here)

Review News Page

SEND Implementation News

  • ADA white paper up for review (Mike to post)


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


  • SEND between Organizations SEND between Organizations
    • LEFT OFF AT Can you provide lists of the mappings used to Controlled Terminology?
    • 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
    • FDA Webinars
      • where?

Action Items

Responsible Task Timeframe
Troy -- Next meeting

Last revision by Troy.smyrnios, 2019-07-16