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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

Email

Kevin Synder

kevin.snyder@fda.hhs.gov

Mark Carfagna

carfagna_mark_a@lilly.com

Lauren White (PHUSE Project Coordinator)lauren@phuse.eu


Key Milestones 

ObjectiveTimeline
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 CSSQ2 2021 
PHUSE Publication or white paperQ2 2021


CURRENT 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
Vehicle Components SurveyDraft White Paper 
SEND Package A
SEND Package B
SEND Package C
SEND Package D

Project Members 

Organisation 
Bill HouserBMS

Cheryl Sloan

BMS

Deepa Smant

Comcast

Erin Mulrooney

BioCelerate

Gen Sato

Eisai

Joseph Horvath

BMS

Michele Dunleavy

Biocelerate
Nicolas PhilippePointCross
Patricia BrundageFDA
Steve PolleyGSK
Sue DehavenSanofi
Todd PageEli Lilly
Wang  WenxianXybion
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