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    SEND Implementation User Group

      SEND Implementation User Group

      Sept 24, 2024

      Project Scope

      New users implementing SEND start out with only the implementation guide as a resource. Having additional places to turn to for assistance (eg forums, Advance Hub, FAQ and PHUSE website) substantially helps new users navigate the pitfalls of SEND implementation, offering them the opportunity to ask questions, receive answers and to discuss and learn more about common implementation issues.

      Project Leads

      Email

      Debra Oetzman, Instem

      debra.oetzman@instem.com

      Troy Smyrnios, Zoetis

      troy.c.smyrnios@zoetis.com

      Alex Pearce, PHUSE Project Assistant

      Alexandra@phuse.global


      CURRENT STATUS Q3 2024

      • The project is inactive and shifting to an on-demand type of mechanism until greater needs potentially arise with implementations of latest nonclinical Study Data Catalog requirements from the FDA. 
      ResourcesDescription
      SEND Implementation WikiA collection of pages for new and current implementers
      SEND Implementation ForumA  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 NewsA simple updates feed of noteworthy events in the SEND space, e.g., release of guide versions, registry notices, etc.
      SEND Implementation FAQThis page covers a knowledge base of Frequently Asked Questions regarding SEND.
      Objectives & DeliverablesTimelines
      Provide and maintain SEND Implementation WikiOngoing
      Provide and maintain SEND Implementation ForumOngoing
      Provide and maintain SEND Implementation NewsOngoing

      Volunteer Today

      The team is formed, but we have room for those interested in continually improving the Advance Hub 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, plus action items - totalling 1-2 hours / month)
      • Expected to contribute, not just be a spectator
      • Contribution of viewpoints and content
      • Advance Hub - creating/reviewing wiki content
      • Forum - participating in discussion

      If you would like to participate, please contact either Lead for this group as seen above.


      Meeting Schedule 

      The team meets 1 hour every 4 weeks in the following structure; 

      • 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
      , multiple selections available,
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