SEND Implementation User Group Minutes 2019-11-19

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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
Ahn Diep X
Audrey Walker
Bill Houser
Brett Coupland
Brian Argo
Cheryl Sloan
Christy Kubin
Jason Rogers
Jeff Cao
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

  • OMORRES - weight vs OWBW (here)
    • Previously Answered
    • Answered bonus question
  • Define.xml length issue (here)
    • Open question
    • Troy to email Jen
  • Question on sample datasets (here)
    • Answered



Open Issues

  • Define.xml length issue (here)
    • Open question
    • Troy to email Jen



Review News Page

SEND Implementation News

  • Added webinar news item


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

  • Help for fit-for-use
    • Library of fit-for-use answers


  • 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
        • There is a public-facing forum/page already?
      • 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
    • Solution
      • Disqus
        • Super fast and would allow for a sharing of contemporary, limited-timeframe information among a set of people
        • Can't really be searched
        • Not a solution for longer term information
        • Use existing forum?
        • NEXT STEPS?
  • OPEN ITEMS*
    • FDA Webinars
      • where?


Action Items

Responsible Task Timeframe
Troy FAQ Outline Next meeting
Troy Jen define length question Next meeting

Last revision by Troy.smyrnios, 2019-11-19