SEND Implementation User Group

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Welcome to the SEND Implementation User Group project, part of the FDA/PhUSE Computational Sciences Nonclinical Working Group. Learn more about the larger working group at Nonclinical_Topics_Working_Group.

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

Need/Challenge

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

Vision

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.

Plans

Two primary avenues have been 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 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.

Tasks

  • Maintain forum and wiki (ongoing)

Deliverables

  • Forum
  • Wiki Articles

Participation Needs

The team is formed, but we have room for those interested in continually improving the wiki or fielding questions on the forum. 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)

What is the commitment?

  • Time (minimum of 1 hour every four weeks for team meetings, up to 1-2 hours / month)
  • Expected to contribute, not just be a spectator
  • Contribution of viewpoints and content
  • Wiki - creating/reviewing page content
  • Forum - participating in discussion

If you would like to participate, please contact the lead for this group: Troy Smyrnios (troy.c.smyrnios@zoetis.com)

Communications

Call for participation (complete)

Periodic telecon (1 per 4 weeks) (ongoing)

Maintenance

Each meeting:

  • Forum questions are reviewed
  • News items are added, if present

Work Group Participants

Lead:

  • Troy Smyrnios, Zoetis
  • Debra Oetzman, Instem

Participants (alphabetical order):

  • Audrey Walker, Charles River
  • Bill Houser, BMS
  • Brian Argo, MPI Research
  • Carrie Neeley, Covance
  • Cheryl Sloan, BMS
  • Christy Kubin, MPI Research
  • Frederic Mura, PDS
  • Jeff Foy, Celgene
  • Jennifer Feldmann, e-Preda
  • Jennifer Keysock, Merck
  • Linda Hunt, Merck
  • Lou Ann Kramer, CDISC
  • Louis Norton, Covance
  • Magda Bleus, Huntingdon Life Sciences
  • Mike Wasko, PDS
  • Sarah Obbers, Janssen
  • SJ, ER Squared, Inc.
  • Wenxian Wang, Xybion

Former members:

  • Dan Potenta, Novartis
  • Pam Hills-Perry, Pfizer
  • Lynda Sands, GSK
  • Peggy Zorn, MMS Holdings
  • Kathy Powers, Pfizer
  • Laura Kaufman, Eagle Pharmaceuticals
  • Donna Danduone, Instem

Collaboration Pages

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

Conference Calls and Minutes

SEND Implementation User Group Minutes


Last revision by Debrao, 2018-02-23