SEND Implementation User Group Minutes 2015-08-10

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When: 2015-08-10, 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 X
Mike Wasko X
Pam Hills-Perry
Peggy Zorn
Sarah Obbers
Tom Ratcliffe
Wenxian Wang


Meetings

Next meeting: 2015-08-24 10-11am EST

Meetings: 4 week schedule

Minutes

General

  • (ON HOLD) 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


Forum

Links:

Review Forum

  • Question on treatments (multiple treatments - how expressed in TX)
    • Yes to adding FAQ item
    • ACTION ITEM: Debra to draft item on multiple treatments question (and to check access)
  • Question on flow cytometry
    • Can be modeled in LB, but has some issues
    • Wiki answer? Yes, but leave it more on the side of no strong push for including
    • Issues with using LB - long test names, missing variables, etc.
    • Flow cytometry -> immunophenotyping (first is one method to achieve second)
    • Refer to phuse working group (Investigating Endpoint Modeling - Biomarkers, ADA data and Immunophenotyping)
    • ACTION ITEM: Troy to draft item on flow cytometry and ADA, linking to phuse team page
  • Question on NDA (2016) vs IND (2017)
    • There are more INDs than NDAs
    • More smaller companies would be affected
    • Bandwidth might be an issue


Review News Page

SEND Implementation News

  • SDRG - nonclinical soon to follow; will be good to put up
  • Study Data Standardization Plan - public comment period expired

Wiki

  • SDRG
    • draft is submitted to FDA; team feels it's really close
    • may end up in different home
    • draft better than nothing, still put up link in FAQ
    • ACTION ITEM: Debra - to draft up FAQ item with link to draft SDRG
  • 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
Jeff Submit CCT item for SEE PROTOCOL on TX's TRTDOS Next meeting
Troy Add FAQ item on extended CT Next meeting
Debra Draft an FAQ item for how to deal with multiple treatments in TX (per forum question) Next meeting
Debra Draft an FAQ item for the SDRG with link to draft Next meeting

Last revision by Troy.smyrnios, 2015-08-10