SEND Implementation User Group Minutes 2015-12-14

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When: 2015-12-14, 10:00am-11:00am EST
Place: Telecon



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


Next meeting: 2015-12-14 10-11am EST

Meetings: 4 week schedule





Review Forum

  • Question on EXCLFL when STAT=NOT DONE
    • SDTM says not to populate EXCLFL
    • Marc: scenario
      • this arised from a PC dataset
      • was part of a large group of them - so they wanted to exclude the batch
    • (ACTION ITEM - Troy) Surface core team item to discuss EXCLFL when STAT=NOT DONE

Review News Page

SEND Implementation News

  • Concept of shared industry calendar
    • Laura has a google calendar and is curating
    • Might be issue on ownership (plenty can update, but still one owner)
    • Ready for mass use
    • Would need steps for people who aren't familiar with
    • (ACTION ITEM - Laura) Set public settings?


  • Handling of SEND in Study Documentation
    • Current text is now wrong, after some paradigm shifts/discussions/etc.
      • SEND datasets not done under the timespan of the GLP study
      • but if datasets are used for interpretation, then they are part of the GLP study, and thus need to abide by all that entails
      • sponsor responsible for ensuring that the datasets accurately represent the study
    • Text from Debra:
      Appropriate verifications need to be done to ensure that data in the SEND datasets are an accurate representation of study data. A positive statement needs to be included in this section. In the event of a directed audit of the data set integrity, the actual verification documentation would most likely be helpful to the auditor.
      An example of a statement is:
      “Data in the SEND datasets are an accurate representation of the data for Study No. 12345. Any differences between the data sets and the report are described in section 6.2. Verification procedures and documentation supporting this are available upon request.”
    • (ACTION ITEM - ?) Update pages:
    • Defer for now


  • 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
Bill Set up "SEND Calendar" / Talk with Laura about trying out wiki page Next meeting
Debra Draft an FAQ item for how to deal with multiple treatments in TX (per forum question) Next meeting

Last revision by Troy.smyrnios, 2015-12-14