SEND Implementation User Group Minutes 2018-07-02

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



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


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




Review Forum

Current Issues

Open Issues

  • IND submission timing 120 days? (here)
    • Answered
  • Question on dose escalation control element (here)
    • Answered

Review News Page

SEND Implementation News

  • Skipped


  • SEND FAQ - 3.1 Updates
    • "Must the define file contain the formulae for calculated measurements?" - updated
    • When and how can you use one define.xml Codelist with multiple variables? - updated
    • What is the proper format of an nSDRG? Does it need

to contain anything specific? - updated

    • Do I have to submit each dose?
      • Added bits (not 3.1 specific, just extra notes)
    • Domain Specifics - CL
      • removed question regarding CL not done cases; only added to confusion by suggesting to do something that would not typically be done
  • Non-GLP
    • Punted timing/considerations to "When Is SEND Mandatory"
      • Put in own section as level 2 under Timing / Regulatory
      • Reworded to simply answer question as yes
    • Updated "When is SEND Mandatory" section
      • Added sections to call out
        • Submission Types and Study Start Timing
        • eCTD Sections - new, added links and clarification on this
        • Documents


  • 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:
        • 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, 2018-07-2