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


Kevin Synder (FDA)

Mark Carfagna (Eli Lilly)

Katie Warren (PHUSE Project Assistant)

Objectives & DeliverablesTimelines
Prioritised list of domains/variables required for harmonisationQ3 2020 
Develop harmonisation recommendations for selected domains/variables and create white paper(s) for specific domains/variables as neededQ2 2021
Poster presentation and update of current Working Group progress at CSSQ3 2021 
PHUSE Publication or White PaperQ2 2022


Recommendations for Consistent Representation of Test Facilities, Test Sites, and Subject Metadata Using SEND Controlled Terminology White Paper sent out for public review​

Recommendations for Populating Control Type (TCNTRL) with CDISC SEND Controlled Terminology

Project Members 

Annika KreuchwigBayer
Bill HouserBristol Myers Squibb

Cheryl Sloan

Bristol Myers Squibb

Deepa Smant


Gen Sato


Joseph Horvath

Bristol Myers Squibb
Matthew CrawleyBiocelerate

Michele Dunleavy

Nicolas PhilippePointCross Life Sciences 
Patricia BrundageFDA
Rick ThompsonJanssen Research & Development
Steve PolleyGSK
Sue DehavenSanofi
Todd PageEli Lilly
Wang WenxianBristol Myers Squibb