SEND Implementation User Group Minutes 2018-11-19

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For other minutes, see the SEND Implementation User Group Minutes page.

Logistics

Meetings

Meetings occur every 4 weeks, at 10-11am EDT.

Attendance

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


Minutes

Special Topics

Forum

Links:

Review Forum


Current Issues

  • Sensitizer question (here)
    • Answered
  • NOMLBL not unique to NOMDY (here)
    • Previously answered
  • nsdrg reference in define (here
    • Previously answered
  • FDA on IND vs NDA (here)
    • Answered (some previously)
  • CBER Q/A item (here)
    • Nothing to do
  • Interim curiosities (here)
    • Answered


Open Issues


Review News Page

SEND Implementation News

  • Nothing

Wiki

  • SEND FAQ - 3.1 Updates
    • Will SEND be developed to cover genetic tox studies?
      • Updated
    • Are Anti-drug Antibody (ADA) and Flow Cytometry Expected?
      • Split
    • Is Anti-drug Antibody (ADA) expected?
      • Created (split from above)
      • Updated
    • Is Flow Cytometry expected?
      • Created (split from above)
    • Are other endpoints being developed?
      • Updated
  • OPEN ITEMS
    • How Do I Handle PK Data or Analysis with CROs/External Labs?
      • reference link to Debra/Audrey document
      • Christy/Brian review link to Template to Facilitate Creating Pharmacokinetic SEND Datasets
    • Is DART / Repro Tox included in SEND?
      • Audrey to ask mary jo about wording for juvenile tox (e.g., noting that it should be excluded)


General

  • SEND between Organizations [[[SEND Implementation Wiki - SEND between Organizations|SEND between Organizations]]
    • Review this
  • PC/PP Template ([Template to Facilitate Creating Pharmacokinetic SEND Datasets])
    • Review this
  • LEFT OFF AT What software is used by reviewers to visualize and review SEND data?
    • Need to update, agnosticize if possible. Somewhere else there is a list of providers, use that instead.
  • Google-izing
    • Standout icon/box things
      • Super stand-out of FAQ on main and some other pages
    • Main page - link overload
      • Fundamentals - reorg under send fundamentals
      • Entry points for brand new user are SEND Fundamentals and Getting SEND-ready
    • FAQ - first glimpse into page is crazy
      • maybe expand first sentence - say what TOC is, idea of search, etc.
      • reduce/remove all links in favor of template links
      • Basics - remove header
    • News not pretty or obvious - make it stand out as not the forum
      • To initiate, confusing what this is
        • needs better header to make it more clear what it is (specifically not the forum)
        • Example of nice version: https://www.cdisc.org/news
        • currently resource constrained
        • Next step #1: PhUSE core team item to evaluate news status quo vs future - get attendee list
        • Next step #2: header
        • Next step #3: email how to use reminder
    • ACTION: Troy to draft text for FAQ and Forum links

Action Items

Responsible Task Timeframe
Troy Simplify home page Next meeting

Last revision by Troy.smyrnios, 2018-11-19