SEND Implementation User Group Minutes 2017-07-10

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When: 2017-07-10, 10:00am-11:00am EDT
Place: Telecon

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



Next meeting: 2017-07-24 10-11am EDT

Meetings: 4 week schedule


Participant Attended
Troy Smyrnios X
Audrey Walker X
Bill Houser
Brian Argo X
Carrie Neeley
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 X
Pam Hills-Perry
Peggy Zorn
Sarah Obbers
Sue DeHaven
Wenxian Wang





Review Forum

  • Dataset placement structure
    • Gitte received some confirmation from edata on placement
    • Bill? Sanofi? received implicit acceptance by another location
    • Open question to resolve, should update with comment on Gitte's question (Search for datasets/tabulation/legacy)
    • Leaving alone for now
  • STRAIN mapping question
    • Previously answered
  • COVAL - splitting words
    • Previously answered; added opinion
  • Dataset Column Length
    • Open question
  • Study Initiation Date / Study Start Date
    • Previously answered
  • PC unscheduled
    • PC/PP Team to deliberate (Audrey and Debra to raise)

Open Questions

  • Search for datasets/tabulation/legacy
    • Audrey to ask about a listing of datasets with preferred location/path
    • Probably will make sense to add FAQ item when dust settles
  • Dataset Column Length
    • Debra to send email to Ben re adding this item to list
  • PC unscheduled
    • PC/PP Team to deliberate (Audrey and Debra to raise)

Review News Page

SEND Implementation News

  • Debra to post item about a bunch of changes to docs (incl technical rejection criteria) - side note: most expected to just be eCTD and not affect SEND


  • SEND FAQ - Big update in near future re: 3.1
    • Sweep through questions to see if need to updated, some may need to have dual answer (e.g., 3.1 answer and 3.0 answer)
    • Hold for now in case they hold out for 3.2
    • Waiting on pilot for safety pharm...

Action Items

Responsible Task Timeframe
 ?  ? Next meeting

Last revision by Troy.smyrnios, 2017-07-10