Difference between revisions of "SEND Implementation User Group"

From PHUSE Wiki
Jump to: navigation, search
(Conference Calls and Minutes)
Line 194: Line 194:
[[Category:FDA Working Groups]]
[[Category:FDA Working Groups]]
[[Category:SEND Implementation User Group]]
[[Category:SEND Implementation User Group]]

Revision as of 15:22, 30 May 2013

Welcome to the Wiki for the SEND Implementation User Group project, part of the FDA/PhUSE Computational Sciences Nonclinical Working Group. Learn more about the larger working group at Non-Clinical Road-map and Impacts on Implementation.

This page describes high-level project management details on the group, including purpose, milestones, attendees, and so on. The content being worked on can be found in the collaboration pages (see the Collaboration Pages section below).

See also:

Overview & Scope


Users currently have only the implementation guide to use when implementing SEND. Having places to go for new users, (e.g., a forum, wiki, FAQ, etc.) could substantially help users navigate the pitfalls of implementation.


Users will have clear places to go for assistance with SEND implementation, with the ability to ask questions, receive answers, discuss issues, and learn more about common implementation issues.


Two primary avenues will be developed to meet the need for user group frameworks and initial content:

  • A Forum, where users can go to ask questions and see previously answered questions
  • A Wiki, where users can go for how-to guides, FAQs, and so on, for helpful implementation information

These two will flow into and out of one another, such that users will be directed from the forum to the wiki for pre-specified FAQs/information, as well as the wiki forwarding users to the forum to actively ask questions and/or discuss.

To ensure success, focus will be on:

  • Establishing manageable governance
  • Getting an initial bolus of participation to establish the framework
  • Ensuring ease of use (the forum and wiki should make getting an answer intuitive)
  • Wiki: Hitting the primary/common use cases and questions, not the one-off questions


(after call for participation / team formation)

  • 1 month
    • Form team (complete)
    • Key bullet points for structure (complete)
  • 2 months
    • Evaluate feasability of using CDISC and/or PhUSE sites (complete)
  • 3 months
    • Moderation plan / security plan (TBD)
    • Forum structure defined (ask the expert vs open forum?)(complete)
    • Wiki structure defined (landing page/scope/faq organization?) (complete)
  • 2-6 months
    • Seeding questions for forum developed (canceled)
    • Wiki articles written (complete)
  • 6 months
    • Forum ready with seeding questions and sticky posts with forum usage and link to wiki (on hold)
    • Wiki ready with landing page (with link to forum) and base set of articles (complete)
    • Publicizing sites
  • After
    • Upkeep/future maintenance



  • Sites
    • Publicizing sites
  • Structure
    • Moderation plan / security plan
  • Content
    • Forum:
      • Sticky posts (how to use, links)
      • Seeding questions
    • Wiki articles:
      • FAQ
      • Fundamentals
      • Known Issues


  • Sites
    • Evaluate feasibility of using CDISC and/or PhUSE sites - phUSE wiki and forum will be used
  • Structure
    • Forum: complete
    • Wiki: Base pages and content bullets defined
    • Wiki: Initial categories defined
  • Content
    • Terms of Use page complete
    • Wiki articles complete


  • Moderation Plan
  • Security Plan
  • Forum Sticky Posts
  • Wiki Articles

Participation Needs

The team is formed, but we have room for more. We are looking for individuals with the following areas of expertise to contribute to this effort:

  • SEND SMEs (experienced with SEND)
  • Submission SMEs (experienced with submissions)
  • New SEND Implementers (those with fresh questions run into during implementation)

The total group is limited to 12-20 people, with representation from all of the above areas of expertise.

What is the commitment?

  • Time - will vary widely (minimum of 1 hour every two weeks for team meetings, up to 4-8 hours / month)
  • Expected to contribute, not just be a spectator
  • Contribution of viewpoints and content
  • (Wiki only) Creating/reviewing page content

If you would like to participate, please contact the co-leads for this group:

  • Forum - Lynda Sands (Lynda.L.Sands@gsk.com)
  • Wiki - Troy Smyrnios (troy.smyrnios@mpiresearch.com)


Call for participation (complete)

Periodic telecon (1 per 2 weeks) (ongoing)




Ideas for broadcasting, when ready to disseminate:

  • Link on FDA data standards page
  • Standard "tell 2 friends" email - complete
  • Link on CDISC SEND page
  • Inclusion in CDISC Newsletter
  • Modify wikipedia SEND entry - complete

Work Group Participants


  • Lynda Sands, GlaxoSmithKline (Forum)
  • Troy Smyrnios, MPI Research (Wiki)


  • Louis Norton, Covance
  • Jennifer Feldmann, Instem
  • Lou Ann Kramer, Lilly
  • Audrey Walker, Charles River
  • Bill Houser, BMS
  • Peggy Zorn, INDS
  • Wenxian Wang, Xybion
  • Sarah Obbers, Janssen
  • Debra Oetzman, Covance
  • Frederic Mura, PDS
  • Jeff Foy, Celgene
  • Cheryl Sloan, BMS
  • Donna Danduone, Instem

Collaboration Pages

The following pages are collaboration pages for members to actively edit with content:

Conference Calls and Minutes

Last revision by DanBoisvert, 2013-05-30