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,  BioCelerate Consortium)

Katie Warren (PHUSE Project Assistant)

Objectives & DeliverablesTimelines
PHUSE Publication of White Paper: Recommendations for Consistent Representation of Test Facilities, Test Sites, and Subject Metadata Using SEND Controlled TerminologyQ2 2022

Q2/3 2022

  • Attended CDISC SEND F2F
  • Currently collaborating on a White Paper 
  • Working on a Poster for PHUSE /FDA CSS 2022

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

Project Members 

Annika KreuchwigBayer
Bill HouserBristol Myers Squibb,  BioCelerate Consortium
Cara Rinaldi BioCelerate

Cheryl Sloan

Bristol Myers Squibb,  BioCelerate Consortium

Deepa Smant

Frank BringezuMerck 

Gen Sato

Joseph Horvath Bristol Myers Squibb
Laura Kaufman Pointcross
Lokesh Babu Pointcross
Michael DeNieu Labcorp
Michael WaskoPDS Life Sciences 

Michele Dunleavy

Nicolas PhilippePointCross Life Sciences 
Patricia BrundageFDA
Rick ThompsonJanssen Research & Development,  BioCelerate Consortium

Rupesk Katta

SivaRamaKrishna VemiReddy Pointcross
Steve PolleyGSK

Sudharrshan Muthukumarasamy

Sue DehavenSanofi
Todd PageEli Lilly
Vidhuna SadanandanLabcorp
Wang WenxianBristol Myers Squibb,  BioCelerate Consortium
William Houser Bristol Myers Squibb