SEND Implementation User Group Minutes 2015-09-21

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When: 2015-09-24, 10:00am-11:00am EST
Place: Telecon



Participant Attended
Troy Smyrnios X
Lynda Sands
Audrey Walker X
Bill Houser
Cheryl Sloan
Dan Potenta X
Debra Oetzman
Donna Danduone
Frederic Mura
Jennifer Feldmann
Jeff Foy X
Kathy Powers
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: 2015-10-19 10-11am EST

Meetings: 4 week schedule



  • (ON HOLD) FDA Questions
    • Laura Kaufman took minutes - to be published soon
    • Some opportunity to incorporate results into FAQ, in particular:
      • QA pieces
      • Statement that data have been checked / systems in place, etc. - "Datasets were verified and accurately reflect the final report" (to be in updated of the conformance guide - more frequent updates)
      • If not raw data, then not GLP/CFR Part 11-bound, but there is expectation that it is validated
      • Which study types, etc. are/aren't covered
    • ECG telemetry data - just what is submitted (e.g., summarized per time point)
    • 2015-05-04: On hold for publish of questions



Review Forum

  • Question on CTrough
    • Answered; no FAQ item needed
  • Question on test substance characteristics (Gitte)
    • Not usually tabulated
    • Response - any which way

Review News Page

SEND Implementation News



  • 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
Debra Draft an FAQ item for how to deal with multiple treatments in TX (per forum question) Next meeting
Debra Draft an FAQ item for the SDRG with link to draft Next meeting

Last revision by Troy.smyrnios, 2015-09-21