SEND Implementation User Group Minutes 2019-10-08

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


Minutes

Forum

Links:

Review Forum


Current Issues

  • VISITDY in CV, RE (here)
    • Previously answered
    • Answered the follow-up
  • TS INTERIM (here)
    • Previously answered
  • TS/TX, DOSFRQ->FREQ? (here)
    • Previously answered
    • Answered the follow-up



Open Issues

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


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)

FAQ structure re-org

  • FDA/Reg
  • Meta/Process (interorg, qa, etc.)
  • Model Questions (stuff all of this down here)
  • define/nsdrg
  • Future

=VISITDY deprecation question

requires re-org of structure; would go in general variables-like section, along with DY, etc.

When to populate VISITDY vs --NOMDY (3.1)? Where is VISITDY in 3.1? 3.0: Populate VISITDY per IG. 3.1: 3.1 marks the beginning of the deprecation of the VISITDY variable; SENDIG 3.2 is expected to completely deprecate VISITDY. --NOMDY is the go-forward representation of the reported day in the datasets.

  • Dataset populators should only populate --NOMDY (and expect VISITDY to be phased out)
  • Recipients should ignore VISITDY in favor of --NOMDY.

Actual day is still represented in --DY, and planned/unplanned is represented in --USCHFL (which covers the meaningful part of the planned day concept).

TSPARM/TXPARM

Which TSPARMs should I include?
Which TXPARMs should I include?
There are two sources of recommended parameters to include - the SENDIG's "Should Include" and the FDA's TCG, which calls out certain parameters. You should at least include both of these sets, as well as any that make sense for your study.
*Note: the long name mentioned in the TCG may not always match the version of CT you are using; use the long name from the CT list)

Which CT should I use for TSPARMs?
Which CT should I use for TXPARMs?
The SENDIG calls out some CT for the TS and TX parameter lists. As of 3.1, this is being worked on. If/when you see CT called out in the SENDIG, use it. Otherwise, use your best judgment.

General

  • Reschedule of next instance per F2F


  • 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, 2019-10-8