SEND Implementation User Group Minutes 2020-03-24

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


Special guest: Maria Francomacaro

Minutes

Forum

Links:

Review Forum


Current Issues

  • Question on analysis results inclusion (here)
  • Previously answered



Open Issues

  • None


Review News Page

SEND Implementation News

  • Webinar post re: CDER - but postponed
  • FDA wednesday virtual thing - posted
  • Animal rule accepted (catalog not updated yet) - posted

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

  • Re-org after 7 years to bucket things
  • Drafted new outline in meeting
  • Troy to send out outline for review
  • Poster idea - 7 years of Implementation wiki, re-org/refresh

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

  • Study report and dataset consistency
    • Working group team catalogued a number of inconsistencies between study report and datasets and published white paper to wiki:

https://www.phusewiki.org/wiki/index.php?title=Data_Consistency:_SEND_Datasets_and_the_Study_Report

    • Maria reached out to see about lifting items from it to implementation wiki
    • Potential content/homes
      • Add to links
      • Add to getting send ready maybe
      • Adding bits to FAQ
        • Cherry picking nuggets
        • Link
    • Keeping it evergreen
      • Idea: keep whitepaper as static, published, create new page that has the table as a living doc
      • Use channel of forum as means to add new items
      • Put out there that people can submit ideas for it to impl team
    • Actions:
      • Maria to check with team on bullet content ("cliff notes")
      • Maria to put out there invitation to join for those who want to become members of impl
  • 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

Last revision by Troy.smyrnios, 2020-03-24