SEND Implementation User Group Minutes 2016-04-04

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

Logistics

Attendance

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


Meetings

Next meeting: 2015-05-02 10-11am EST

Meetings: 4 week schedule

Minutes

PhUSE CSS

  • New teams added
    • Scripts
    • Study report / dataset differences - may result in more items
    • Increasing test submissions - kathy brown leading this one with dave epstein


General

Forum

Links:

Review Forum

  • Question on test CT vs testcd CT
    • (ACTION ITEM - Troy) add item to FAQ on paired codelists, e.g., test, testcd
  • Question on time portion of PC/PP
    • Time portion may or may not be readily available
    • Some are working toward including/merging it
    • Not historically required for tabulation
    • Generally speaking - "match your study report"
    • Add FAQ item? e.g., you are fine without time, but take measures to improve getting it in. - No, leave as is for now.
    • Sent item to Lou Ann/Jamie for consideration on asking FDA
  • Question on EU/Japan
    • Added bit on Japan to FAQ
  • Question on PK unit extensibility - no response required


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 - wait until SQA happens (right now - 4/4) - Bill, Jamie, Sue, etc.
      • (ACTION ITEM - Troy) Invite Bill, Jamie, Sue, Jen to 5/2 meeting
  • Known Issues
    • 3.0 items given a heading to make it clear they are 3.0 (because they are still valid for a while after 3.1 is in place)
    • Future evaluation of where errata go...


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, 2016-04-4