Optimizing the Use of Data Standards – Project Volunteer Board
Welcome! |
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Interested in joining one of the Optimizing the Use of Data Standards Working Group Projects? The projects below welcome new volunteers. |
SDTM ADaM Implementation FAQ – Started Q2 2024 | |
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Project Scope: The Standards Implementation Nuances sessions at the March North America 2016 CSS and June EU 2016 CSS surfaced various common challenges amongst SDTM and ADaM implementers and consumers. In addition, there were many questions discussed related to data submissions requirements by various regulatory agencies around the world (e.g. FDA, PMDA, NMPA). It became very clear that the Industry is in need of a forum and subsequent knowledge-base (FAQ) to address these challenges. This project team was formed in June 2016 to collaborate with Subject Matter Experts (SMEs) from the industry, CDISC, and the FDA. The goal of this project team is to:
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Key Skills: (currently being reviewed by WG Leads)
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Building a Better MDR – Started Q3 2025 | |
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Identify use cases (e.g. standards librarian versus data manager versus programmer) for MDRs (focused on cross-study data standards), functions and features and best practices of an “ideal” vendor-neutral MDR so organisations can align services, systems, and tools accordingly. This “wish list” could be used for RFIs/RFPs as organisations evaluate (or used as requirements to build) systems and tools for their MDR needs. Incorporating a better MDR will lead to efficiencies in standards implementation and maintenance, facilitate end-to-end standards implementation and automation, and improve standards compliance. | Project Kick Off Meeting:
Key Skills:
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