SEND Implementation User Group Minutes 2016-12-12

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When: 2016-12-12, 10:00am-11:00am EDT
Place: Telecon

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



Next meeting: 2017-01-09 10-11am EDT

Meetings: 4 week schedule


Participant Attended
Troy Smyrnios X
Audrey Walker
Bill Houser
Brian Argo
Carrie Neeley
Cheryl Sloan
Christy Kubin X
Dan Potenta
Debra Oetzman X
Donna Danduone
Frederic Mura
Jamie Megna
Jennifer Feldmann
Jeff Foy X
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



Review Forum

  • SDRG formatting
    • Provided some basic answer - request for more info if it doesn't work.

Review News Page

SEND Implementation News

  • Debra: Ben is collecting feedback for Technical Conformance Guide - would be good news item
    • Troy to email Ben to ask how he would like to receive feedback
  • Debra: Christy is leading Data Conformance Rules
    • Min confirmation rules
    • FDA rep
    • Rep from tool vendors
    • No business rules (above/beyond conformance rules)
    • Three levels: FDA business rules, Data Conformance Rules, tool-vendor-specific
    • Christy to post item


Action Items

Responsible Task Timeframe
 ? Update pages discussing QA/Validation/SD (see above) Next meeting
Debra Draft up a picture that could make the PC/PP analyte situation clearer Next meeting

Last revision by Troy.smyrnios, 2016-12-12