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Project Scope

The scope of this project is to evaluate and recommend approaches for SEND harmonization 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 Synder (FDA)

kevin.snyder@fda.hhs.gov

Mark Carfagna (Eli Lilly,  BioCelerate Consortium)

carfagna_mark_a@lilly.com

Katie Warren (PHUSE Project Assistant)

katie@phuse.global


Objectives
and
& 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 2021Poster presentation and update of current Working Group progress at CSSQ3 2021 
PHUSE Publication
or
of White Paper
Q2 2022

Status
colourBlue
titleCurrent Status
Q12022

: Recommendations for Consistent Representation of Test Facilities, Test Sites, and Subject Metadata Using SEND Controlled Terminology
White Paper sent out for public review​
Q2 2022


Status
colourBlue
titleCurrent Status
Q2/3 2022

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


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



Project Members 

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

Cheryl Sloan

Bristol Myers Squibb,  BioCelerate Consortium

Deepa Smant

Comcast
Frank BringezuMerck 

Gen Sato

Eisai 
Joseph HorvathHorvath Bristol Myers Squibb
Laura Kaufman Pointcross
Lokesh Babu Pointcross
Michael DeNieu Labcorp
Michael WaskoPDS Life Sciences Matthew CrawleyBiocelerate

Michele Dunleavy

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

Rupesk Katta

Xybion
SivaRamaKrishna VemiReddy Pointcross
Steve PolleyGSK

Sudharrshan Muthukumarasamy

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