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Project Scope

New users implementing SEND start out with only the implementation guide as a resource. Having additional places to turn 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

Lauren White (
Alex Pearce, PHUSE Project
Coordinator)Objectives and DeliverablesTimelinesProvide and maintain SEND Implementation WikiOngoingProvide and maintain SEND Implementation ForumOngoingProvide and maintain SEND Implementation NewsOngoing
Assistant
lauren@phuse.global

Alexandra@phuse.global


Resources

Status
colourBlue
titleCurrent Status

 Q12021

Team looking to revamp the structure of the FAQ page whilst continuing to support the forum and news page. 

Project Members 

Organisation 

Anh Diep

MyoKardia

Audrey Walker

Charles River

Bill Houser

BMS

Brett Coupland

AstraZeneca

Brian Argo

MPI Research

Cheryl Sloan

BMS

Christy Kubin

MPI Research

Jeff Cao

Viitai

Project Members 

Organisation Jeff FoyCelgeneLou Ann KramerCDISCMike WaskoPDS Life SciencesRick ThompsonJanssen Research & DevelopmentRihab KordaneCertaraVirginie OryIpsen

Wai-Fung Chau

GE Healthcare

Wenxian Wang

Xybion

Q1 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
Wenxian WangXybion
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

meet

meets 1 hour every 4 weeks in the following structure; 

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

Anh Diep

MyokardiaAudrey WalkerCharles RiverBill HouserBMSBrett CouplandAstraZenecaBrian ArgoMPI ResearchCheryl SloanBMSChristy KubinMPI ResearchJason RogersEnvigoJeff CaoViitaiJeff Foy

Celgene

Lou Ann KramerCDISCMike WaskoPDSRick ThompsonJanssen Research & DevelopmentRihab KordaneCertaraVirginie OraIpsenWai-Fung ChauGE