SEND Implementation User Group Minutes 2017-04-03

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When: 2017-04-03, 10:00am-11:00am EDT
Place: Telecon

For other minutes, see the SEND Implementation User Group Minutes page.



Next meeting: 2017-05-01 10-11am EDT

Meetings: 4 week schedule


Participant Attended
Troy Smyrnios X
Audrey Walker
Bill Houser X
Brian Argo X
Carrie Neeley X
Cheryl Sloan
Christy Kubin X
Dan Potenta
Debra Oetzman X
Donna Danduone
Frederic Mura
Jamie Megna
Jennifer Feldmann
Jeff Foy
Kathy Powers
Kev Martin
Linda Hunt
Lou Ann Kramer
Louis Norton
Lynda Sands
Mike Wasko
Pam Hills-Perry
Peggy Zorn
Sarah Obbers
Sue DeHaven
Wenxian Wang X



  • Rejection criteria
    • Example Q: Why is TS required / completeness
    • Debra to send list to Troy for spitball "where should it go?"
    • Technical rejection versus Refuse to File rejection
    • Added to FAQ new section for Tech Rejection Qs



Review Forum

    • Previously answered
  • Sample dose level, diff sacrifice - 2 elements?
    • Previously answered
    • Added bit on how it could go either way (e.g., split in set)
  • Study terminated halfway
    • Previously answered
  • FDA TX split
    • Previously answered
    • Added quote from TCG
  • Question on new TS requirement
    • Previously answered
    • added link to FAQ
  • Character set
    • Previously answered
  • Multiple STUDYIDs
    • Previously answered (not in SEND intent to support in single package)
  • Phys Exams
    • Previously answered
    • Previously answered
  • Phototox
    • Previously answered
    • put a thing in the study types section of FAQ
  • TK/tolerability
    • Previously answered
  • SPID
    • Answered
    • Previously answered
    • Added bit on 3.1
  • Oral Tox with FOB
    • Previously answered
    • Added tie-breakers
  • Electron Microscopy
    • Previously answered
    • Added bit on whether or not to do it, plus recommended value for METHOD if you do

Review News Page

SEND Implementation News


  • QA/Validation

    • SQA - no definitive answer, but they did say company preference
  • SEND FAQ - Big update in near future

Action Items

Responsible Task Timeframe
 ?  ? Next meeting

Last revision by Troy.smyrnios, 2017-04-3