SEND Implementation User Group Minutes 2015-08-24

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When: 2015-08-24, 10:00am-11:00am EST
Place: Telecon



Participant Attended
Troy Smyrnios X
Lynda Sands
Audrey Walker
Bill Houser
Cheryl Sloan
Dan Potenta
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
Peggy Zorn
Sarah Obbers
Tom Ratcliffe
Wenxian Wang


Next meeting: 2015-09-21 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 SEE PROTOCOL wrt TRTDOS
    • Jeff submitting as comment
    • Also EXDOS = numeric
  • Question on timing variables (ELTM vs TPTREF)
    • Revised wording in 3.1 should make things clearer (as clear as we can imagine they could be)
    • No action


  • Question on treatments (multiple treatments - how expressed in TX)
    • Yes to adding FAQ item
    • ACTION ITEM: Debra to draft item on multiple treatments question (and to check access)
  • Question on SDRG
    • Yes - add an FAQ item for this (i.e., liked by FDA)
    • draft is submitted to FDA; team feels it's really close
    • may end up in different home
    • draft better than nothing, still put up link in FAQ
    • ACTION ITEM: Debra - to draft up FAQ item with link to draft SDRG

Review News Page

SEND Implementation News

  • Study Data Standardization Plan - public comment period expired



  • 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