Difference between revisions of "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]].
 
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).
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This page describes <b>high-level project management details</b> on the group, including purpose, milestones, attendees, and so on.
  
See also:
+
Actual deliverables are elsewhere, and include:
*[[Nonclinical_Topics_Working_Group|Nonclinical Topics Working Group]]
+
* [[SEND Implementation Wiki]] - a collection of pages for new and current implementers
*[[SEND Implementation Wiki]]
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** Fundamentals pages for new implementers
*[[SEND Implementation Forum]]
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** [[SEND Implementation Wiki - FAQ]] - a large body of questions and answers
*[[SEND Implementation Wiki Contributor Guide]]
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* [[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.
  
 
== Overview & Scope ==
 
== Overview & Scope ==
  
 
===Need/Challenge===
 
===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.
 
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===
 
===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.
  
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.
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=== Exclusions ===
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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==
 
==Plans==
 
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Persist the forum and wiki as a service indefinitely and keep content evergreen.
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==
 
==Deliverables==
 
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We generate and maintain:
*Forum
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*[[SEND Implementation Wiki]] - a collection of pages for new and current implementers
*Wiki Articles
+
** Fundamentals pages for new implementers
 +
** [[SEND Implementation Wiki - FAQ]] - a large body of questions and answers
 +
* [[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==  
 
==Participation Needs==  
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Call for participation <font color="green">(complete)</font>
 
Call for participation <font color="green">(complete)</font>
  
Periodic telecon (1 per 4 weeks) <b>(ongoing)</b>
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Periodic telecon (1 hour meeting every 4 weeks) <b>(ongoing)</b>
  
 
===Maintenance===
 
===Maintenance===
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*Peggy Zorn, MMS Holdings
 
*Peggy Zorn, MMS Holdings
 
*Sarah Obbers, Janssen
 
*Sarah Obbers, Janssen
 
==Collaboration Pages==
 
The following pages are collaboration pages for members to actively edit with content:
 
*[[SEND Implementation User Group - Wiki Categories]]
 
  
 
== Conference Calls and Minutes ==
 
== Conference Calls and Minutes ==

Revision as of 12:11, 18 October 2019


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:

  • 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.

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.

Exclusions

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

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 hour meeting every 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
  • 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
  • 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, 2019-10-18