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Project Scope= p> |
The scope of this project is to evaluate and recommend appro= aches for SEND harmonization to better enable analysis of historical contro= l data. SEND harmonization strategies include creation of new variables, co= ntrolled terminology, preferred terms, reference lists and/or analysis stra= tegies (scripts) to enable cross-study analysis. Developing a solution fram= ework for variability that includes representation of stakeholders involved= in the creation and use of SEND datasets will enable more efficient routin= e analysis of warehoused SEND data. |
Project Leads |
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Kevin Snyder, FDA |
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Mark Ca= rfagna, Eli Lilly |
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Alex Pearc= e, PHUSE Project Assistant |
CURRENT STATUS Q4 2023 |
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Objectives & Deliverables | Timelines |
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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 studies | Q2 2023 |
Continued work on consulting with= other consortia to understand the critical data needed for virtual control= s defining | Q3 2023 |
Host a workshop at the PHUSE CSS<= /span> | Q3 2023 |