SEND Implementation User Group Minutes 2015-10-19

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When: 2015-10-19, 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 X
Kev Martin
Linda Hunt
Lou Ann Kramer
Louis Norton
Marc Ellison X
Mike Wasko
Pam Hills-Perry X
Peggy Zorn
Sarah Obbers
Tom Ratcliffe
Wenxian Wang X


Next meeting: 2015-11-16 10-11am EST

Meetings: 4 week schedule





Review Forum

  • EX unplanned
    • Answer ok in forum
    • In case of missed dose, dosing data wouldn't be reported in the tabulations anyway (outside of usual deviations, etc.)
    • Only actuals belong in this least for now
    • But should it be...not needed, but is it harmful?
    • CCT item was submitted a long time ago, but was resolved as actual dosing only (EX will be re-looked at in the future)
  • TK animals written out of report => what in SEND?
    • Collected <> reported
    • If not reported, not required in SEND, but up to sponsor
    • Probably still warrants an SDRG note
  • LAT for organs in MA/MI
    • Answer is good - whatever you actually did/examined
    • Added note on UNILATERAL

Review News Page

SEND Implementation News

  • Debra added item on comment period of SDRG - thanks!
  • 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
Troy Contact PhUSE tech guys about shared calendar 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, 2015-10-19