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Project Scope

The scope of this project is to evaluate and recommend approaches for SEND harmonization to better enable analysis of historical control data. SEND harmonization strategies include creation of new variables, controlled terminology, preferred terms, reference lists and/or analysis strategies (scripts) to enable cross study analysis. Developing a solution framework for variability that includes representation of stakeholders involved in the creation and use of SEND datasets will enable more efficient routine analysis of warehoused SEND data.



Project Leads

Email

Kevin Snyder (, FDA)

kevin.snyder@fda.hhs.gov

Mark Carfagna (, Eli Lilly)

carfagna_mark_a@lilly.com

Alex Pearce (, PHUSE Project Assistant

Alexandra@phuse.global


Status
colourBlue
titleCurrent Status
Q2 2023

  • Project Successfully kicked-off 
  • Working document templates agreed




Objectives & DeliverablesTimelines
Develop plans for a new, re-scoped project that will focus exclusively on applying harmonisation of SEND data to facilitate implementation of virtual control groups in toxicology studies.Q2 2023