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Harmonization of SEND Implementation to Enable Historical Control Data Analysis

Harmonization of SEND Implementation to Enable Historical Control Data Analysis

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Last updated: Feb 07, 2024 by Alex Pearce

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 Snyder, FDA

kevin.snyder@fda.hhs.gov

Mark Carfagna, Eli Lilly

carfagna_mark_a@lilly.com

Alex Pearce, PHUSE Project Assistant

Alexandra@phuse.global

CURRENT STATUS 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

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