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The scope of this project is to evaluate and recommend approaches for |
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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 |
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Kevin |
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Snyder, FDA |
Mark Carfagna |
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, Eli Lilly | |
Alex Pearce, PHUSE Project Assistant |
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Resources |
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Recommendations for Populating Control Type (TCNTRL) with CDISC SEND Controlled Terminology Supporting the Use of SEND for the Implementation of Virtual Control Groups |
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 controls defining | Q3 2023 |
Host a workshop at the PHUSE CSS | Q3 2023 |