SEND Implementation User Group Minutes 2016-08-22

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When: 2016-08-22, 10:00am-11:00am EST
Place: Telecon

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



Participant Attended
Troy Smyrnios X
Audrey Walker X
Bill Houser
Brian Argo X
Carrie Neeley
Cheryl Sloan X
Christy Kubin
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


Next meeting: 2015-10-17 10-11am EST

Meetings: 4 week schedule





Review Forum

  • FW question
    • Previously answered
    • (ACTION ITEM - Troy) Add FAQ item on FW - raw vs reported (e.g., no one reports feeder records; contention on whether daily or reported) and estimated (e.g., pro-rated consumption in case of spill, death, etc.)
    • (ACTION ITEM - Troy) Add core team item on FW - get a feel for how many people do what
    • Previously answered
  • SENDIG mandatory
    • Previously answered
  • CT extensibility
    • Previously answered
  • Define 2.0
    • Big issue - commented that Audrey is bringing this up as an issue
  • Study Decisions
    • Previously answered
    • Added clarification on study handling page
  • VISITDY question
    • Answered
    • Still can be a number of concepts right now (e.g., 24hr = 1 or 2, depending on sponsor, basically) - 3.1 reins it in a little
  • PCDTC question
    • Answered

Review News Page

SEND Implementation News


  • Tumor.xpt item
    • Current wiki text says not required
    • Probably is still desired if not required by FDA
    • (ACTION ITEM - Troy) Get core team meeting item added for tumor.xpt expectancy

  • Known Issues
    • 3.0 items given a heading to make it clear they are 3.0 (because they are still valid for a while after 3.1 is in place)
    • Future evaluation of where errata go...

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
Troy Add wiki item for STRESU/TEST issue Next meeting
Troy Create FAQ Item for textual LBORNRLO and LBORNRHI Next meeting

Last revision by Troy.smyrnios, 2016-08-22