SEND Implementation User Group Minutes 2015-11-16

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When: 2015-11-16, 10:00am-11:00am EST
Place: Telecon



Participant Attended
Troy Smyrnios X
Lynda Sands
Audrey Walker
Bill Houser X
Cheryl Sloan
Dan Potenta
Debra Oetzman X
Donna Danduone
Frederic Mura
Jennifer Feldmann
Jeff Foy
Kathy Powers
Kev Martin
Linda Hunt
Lou Ann Kramer
Louis Norton
Marc Ellison X
Mike Wasko
Pam Hills-Perry
Peggy Zorn
Sarah Obbers
Tom Ratcliffe
Wenxian Wang X


Next meeting: 2015-12-14 10-11am EST

Meetings: 4 week schedule



  • FDA Questions
    • SEND FDA Interactions
    • Q: Study types
      • SEND Versioning
        • 3.0 and 3.1 as standards - study has data that can't fully be in 3.1, is required to submit in 3.1, even though 3.0 is still valid
        • Criteria
          • One active at any given time, with ample lead time
          • Based on study start
          • SEND 3.0 active July 2011 - early 2017 (made up date)
          • SEND 3.1 released early 2016, made required early 2017: Early 2017 - March 2021
          • SEND 4.0 active March 2021 - ...
          • If submission is years later, long-running study, you are ok to submit future versions (minimum version based on study start)
        • (ACTION ITEM - Troy) Make draft version of FAQ item for the send versions, include link to SEND FDA Interaction
      • Study type priority
        • Just in time releases?
        • Unbundling to increase speed?
        • FDA to push on less value-added effort items if value to study type at whole?
        • Strategy off this is TBD
      • Clarity to what is/isn't modeled - some wording to add clarity to some domains (e.g., clarifying OM as primarily port-mortem)
      • Data not modeled in an IG is not required
    • Q: Controlled terminology >1 versions
      • Supplemented existing FAQ items
    • Discussion: edata
    • Discussion: visitdy, nom--, etc.
      • (ACTION ITEM - Troy) Add FAQ for upcoming SENDIG versions (rotating over time as items are promoted to main FAQ)
      • (FOR NEXT MEETING) Discuss some items around NOMDY, other new 3.1 things, etc.



Review Forum

  • Question on unplanned TK animals
    • Resolution: sponsor has to decide what they consider planned/unplanned
  • Question on Clinical Signs Follow-up
    • Resolution: ask people who actually know how these work to reply (Gitte plus two others Gitte mentioned)
  • Question on vet obs
    • Resolution: answer with reference to FAQ page

Review News Page

SEND Implementation News

  • Concept of shared industry calendar
    • Issue of keeping up to date
      • Laura volunteered to do a good amount of curation
      • Add step to our meeting
    • Technology
      • Google calendar is cumbersome
      • Might be opportunity from PhUSE end
        • Troy - contact PhUSE tech guys
      • Wiki page? Try out where dates are in descending order?
      • "SEND Calendar" as a page? Try out first?
        • Bill - to try setting up/talk with Laura/etc.



  • Known Issues
    • Many of these issues are 3.0 and have been fixed in 3.1
    • End of summer for 3.1 - circle back at that time to discuss what should be on this page

Action Items

Responsible Task Timeframe
Troy Add FAQ item on extended CT Next meeting
Bill Set up "SEND Calendar" / Talk with Laura about trying out wiki page Next meeting
Debra Draft an FAQ item for how to deal with multiple treatments in TX (per forum question) Next meeting

Last revision by Troy.smyrnios, 2015-11-16