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.

Actual deliverables are elsewhere, and include:

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 need 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.

In Scope

We provide and maintain:

Out of Scope

We do not:

  • Define priorities for SEND (e.g., new subject areas) – this is the main SEND team
  • Interact with FDA directly (although often will prompt edata questions and/or assimilate their responses)
  • Interact with vendors, etc. to provide voice of the community or influence direction

Plans

Persist the forum and wiki as a service indefinitely and keep content evergreen.

Deliverables

We generate and maintain:

  • SEND Implementation Wiki - a collection of pages for new and current implementers
  • SEND Implementation Forum - a place for people to ask questions and get answers from experts in the community (and us). We provide review and ensure that every question is answered (although many are answered before our regular meeting) and considered beyond the forum.
  • SEND Implementation News - a simple updates feed of noteworthy events in the SEND space, e.g., release of guide versions, registry notices, etc.

Participation Needs

Joining Our Team

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)

Meetings

We meet 1 hour every 4 weeks.

Typical course of the meetings:

  • BAU:
    • Address any open items on the forum page (and consider additions to the FAQ page)
    • Add any news to the news page
  • CI:
    • Update/refine/create various wiki pages per version releases, guidance changes, etc.
    • Special topics

Every meeting’s minutes are stored on the SEND Implementation User Group Minutes page.

Work Group Participants

Lead:

  • Troy Smyrnios, Zoetis
  • Debra Oetzman, Instem

Participants (alphabetical order):

  • Anh Diep, Myokardia
  • Audrey Walker, Charles River
  • Bill Houser, BMS
  • Brett Coupland, AstraZeneca
  • Brian Argo, MPI Research
  • Cheryl Sloan, BMS
  • Christy Kubin, MPI Research
  • Jason Rogers, Envigo++++
  • Jeff Cao, Viitai
  • Jeff Foy, Celgene
  • Lou Ann Kramer, CDISC
  • Mike Wasko, PDS
  • Rick Thompson, Janssen
  • Rihab Kordane, Certara
  • Virginie Ora, Ipsen
  • Wai-Fung Chau, GE
  • Wenxian Wang, Xybion

Former members (alphabetical order):

  • Carrie Neeley, Covance
  • Dan Potenta, Novartis
  • Donna Danduone, Instem
  • Frederic Mura, PDS
  • Kathy Powers, Pfizer
  • Jennifer Feldmann, e-Preda
  • Jennifer Keysock, Merck
  • Laura Kaufman, Eagle Pharmaceuticals
  • Linda Hunt, Merck
  • Louis Norton, Covance
  • Lynda Sands, GSK
  • Pam Hills-Perry, Pfizer
  • Peggy Zorn, MMS Holdings
  • Sarah Obbers, Janssen

Conference Calls and Minutes

SEND Implementation User Group Minutes


Last revision by Troy.smyrnios, 2019-11-8