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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

carfagna_mark_a@lilly.com

Lauren White (
Alex Pearce, PHUSE Project
Coordinator)
Assistant
lauren@phuse.global

Alexandra@phuse.global


Key Milestones 

ObjectiveTimelinePrioritised 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 CSSQ2 2021 PHUSE Publication or white paperQ2 2021

Status
colourBlue
titleCurrent Status

 Q42020
  • Prioritized four domains/variables for harmonization based on feedback from the educational breakout session at CSS
  • Developed strategies and timelines to provide supporting information (white papers) to CDISC for consideration in SENDIG 3.2
  • Initiated work to outline the scope of the white papers and began writing
Resources

Q4 2023

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


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
Vehicle Components SurveyDraft White Paper SEND Package ASEND Package BSEND Package CSEND Package D

Project Members 

Organisation Bill HouserBMS

Cheryl Sloan

BMS

Deepa Smant

Comcast

Erin Mulrooney

BioCelerate

Gen Sato

Eisai

Joseph Horvath

BMS

Michele Dunleavy

BiocelerateNicolas PhilippePointCrossPatricia BrundageFDASteve PolleyGSKSue DehavenSanofiTodd PageEli LillyWang  WenxianXybion