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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 (

Snyder, FDA

)

kevin.snyder@fda.hhs.gov

Mark Carfagna

(

, Eli Lilly

,  BioCelerate Consortium)

carfagna_mark_a@lilly.com

Katie Warren (
Alex Pearce, PHUSE Project Assistant
)

katie@phuse.global

Alexandra@phuse.global


Objectives & DeliverablesTimelinesPrioritised list of domains/variables required for harmonisationQ32020 Develop harmonisation recommendations for selected domains/variables and create white paper(s) for specific domains/variables as neededQ22021Poster presentation and update of current Working Group progress at CSSQ32021 PHUSE Publication of White PaperQ22022

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​

Q4 2023

  • Re-scoping the project to focus on virtual control data


Resources 
Resources 

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

Supporting the Use of SEND for the Implementation of Virtual Control Groups



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 studiesQ2 2023
Continued work on consulting with other consortia to understand the critical data needed for virtual controls definingQ3 2023
Host a workshop at the PHUSE CSSQ3 2023

Project Members 

Organisation Annika KreuchwigBayerBill HouserBristol Myers Squibb,  BioCelerate ConsortiumCara Rinaldi BioCelerate

Cheryl Sloan

Bristol Myers Squibb,  BioCelerate Consortium

Deepa Smant

ComcastFrank BringezuMerck 

Gen Sato

Eisai Joseph Horvath Bristol Myers SquibbLaura Kaufman PointcrossLokesh Babu PointcrossMatthew CrawleyBiocelerate Michael DeNieu LabcorpMichael WaskoPDS Life Sciences 

Michele Dunleavy

BiocelerateNicolas PhilippePointCross Life Sciences Patricia BrundageFDARick ThompsonJanssen Research & Development,  BioCelerate ConsortiumSivaRamaKrishna VemiReddy PointcrossSteve PolleyGSKSue DehavenSanofiTodd PageEli LillyVidhuna SadanandanLabcorpWang WenxianBristol Myers Squibb,  BioCelerate ConsortiumWilliam Houser Bristol Myers Squibb