SEND Implementation User Group Minutes 2015-05-04

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When: 2015-05-04, 10:00am-11:00am EST
Place: Telecon



Participant Attended
Troy Smyrnios X
Lynda Sands
Audrey Walker X
Bill Houser X
Cheryl Sloan X
Dan Potenta
Debra Oetzman
Donna Danduone
Frederic Mura
Jennifer Feldmann
Jeff Foy
Kathy Powers X
Kev Martin
Linda Hunt
Lou Ann Kramer
Louis Norton
Marc Ellison
Mike Wasko
Pam Hills-Perry
Peggy Zorn
Sarah Obbers
Tom Ratcliffe
Wenxian Wang X


Next meeting: 2015-06-01 10-11am EST

Meetings: 4 week schedule



  • 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

  • Extending CT
    • List out all CT
    • If extensible, then you should state in SDRG (Separate from the define.xml, the guidance is to also include the extended terms in the Study Data Reviewer's Guide (SDRG) under the "Nonstandard Terminology" section to provide human-readable clarity to the reviewers on the additional terms used.)
    • Troy: add FAQ question
    • Troy: add point in define.xml fundamentals
    • Troy: ask laura,debra,sue about nonclinical SDRG link (and that they should add a link to their page @
  • Clinical ARMCDs
    • Nobody uses these

Review News Page

SEND Implementation News

  • Action item: Audrey to add news item for Data Standards Catalog 4.1


  • Getting SEND-ready
    • No additional feedback
    • Troy: send "last call" email

Action Items

Responsible Task Timeframe
Jeff Submit CCT item for SEE PROTOCOL on TX's TRTDOS Next meeting
Audrey Add news item for Data Standards Catalog 4.1 Next meeting
Troy Add FAQ item on extended CT Next meeting
Troy Ask SDRG team to provide/add link Next meeting
Team Review Getting SEND-ready page for the sponsor responsibilities and roles sections Next meeting

Last revision by Troy.smyrnios, 2015-05-4