SEND Implementation User Group Minutes 2016-03-07

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When: 2016-03-07, 10:00am-11:00am EST
Place: Telecon

Logistics

Attendance

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


Meetings

Next meeting: 2015-04-04 10-11am EST

Meetings: 4 week schedule

Minutes

PhUSE CSS

  • Christy, Brian, and Debra created an awesome poster, to be displayed at the upcoming CSS

General

Forum

Links:

Review Forum

  • Question on domains for juvenile with Repro component - response ok, no further action needed
  • Question on CT for NMRI strain - added response, no further action needed
  • Question on PK (BA/TK)
    • Answer good
    • Added FAQ item under PK domain section - How Do I Handle PK Data or Analysis with CROs/External Labs?


Review News Page

SEND Implementation News

  • Carryover*
    • 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?

Wiki

  • Handling of SEND in Study Documentation
    • Current text is now wrong, after some paradigm shifts/discussions/etc.
      • SEND datasets not done under the time span 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

--Carryover--

  • 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
 ? Update pages discussing QA/Validation/SD (see above) Next meeting
Bill Set up "SEND Calendar" / Talk with Laura about trying out wiki page Next meeting

Last revision by Troy.smyrnios, 2016-03-7