SEND Implementation User Group Minutes 2018-06-04

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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
Audrey Walker X
Bill Houser
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

Forum

Links:

Review Forum


Current Issues

  • SEND prior than needed (here)
    • Previously answered
  • SEND RELREC (here)
    • Previously answered
  • SEND Required (here)
    • Previously answered
  • Custom domain codes (here)
    • Previously answered
  • ([1] here)
    • Answered
  • nSDRG who creates datasets (here)
    • Previously answered
  • IND submission timing 120 days? (here)
    • Answered as much as it can be answered



Open Issues

  • IND submission timing 120 days? (here)
    • REVISIT THIS NEXT SESSION


Review News Page

SEND Implementation News

  • New item from Gitte on TRC wording for TS - still up in the air

Wiki

  • SEND FAQ - Big update in near future re: 3.1
    • "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


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, 2018-06-4