SEND Implementation User Group Minutes 2015-03-09

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When: 2015-03-09, 10:00am-11:00am EST
Place: Telecon

Logistics

Attendance

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


Meetings

Next meeting: 2015-04-06 10-11am EST

Meetings: 4 week schedule

Minutes

General

  • PhUSE CSS
    • New poster:
      • Accepted
      • Lynda to print
      • Someone present to present: Debra and Wenxian
  • FDA questions
    • TBD on format of answered questions (may be mix of formal response and people's notes)

Forum

Links:


Broadcasting presence of forum capability

  • Additional outlets for socializing forum:
    • (Jeff) ACT: Jeff may know a contact to give a first shot at it
      • 2014-09-22: president of ACT
    • (Donna) The IQ group (htp://iqconsortium.org): cold call
      • 2014-07-28: In Progress - Donna spoke to part of board Mahalaya Marshall, who is interested (email, site, etc.?), talking to Maggie Lou
      • 2014-08-25: Pinged again

Review Forum

  • "QC type data - where a lab collects followup or checks on previous steps (e.g., micro confirmation of observations - no place for the "no microscopic correlate" entry)
    • Suggestion is to use comments - not ideal, but then something of an operational edge case (not critical to regulatory submissions)
    • Comment on the spec for the MA but no MI case?
    • Need to be submitted - no?
    • MA to MI handling is inconsistent with CL to MA (which has a CLSF test)
    • Core item - Troy to submit
  • Question on data not in report
    • No FAQ item (yet) - series of questions to FDA should cover this and more
  • Question on STUDYID (sponsor's or CRO's)
    • Jen included the Study Data Standards Team's response
    • Need to add FAQ item
  • Question on applicability of GLP to SEND datasets
    • Response is good but nebulous, esp around pre-finalization datasets. Need to draw distinction between interim datasets and the datasets (e.g., for draft report) that are used for making study decisions.
    • Is one of the questions for FDA on the 18th; hopefully to get clarification from there.

Review News Page

SEND Implementation News

  • Not reviewed

Wiki

  • None

Action Items

Responsible Task Timeframe
Troy Create frame of roles/skills section of Getting SEND-ready Next meeting
Troy Add FAQ entry for STUDYID question from forum Next meeting
Troy Add to DISQUS FAQ page the bit about your email Next meeting
Donna Contact the IQ group (htp://iqconsortium.org) Next meeting



Last revision by Troy.smyrnios, 2015-03-9