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: Programmers/Programming Managers
Experience with SDTM, ADaM, Define.xml, or custom study builds; comfort with JSON, Excel metadata, and study design workflows is a plus. Data Managers and Study Builders
First-hand experience with the operational standards embedded in EDCs and other systems—edit checks, functions, templates; experience handling CRF and External data. Standards Governance SMEs
Involved in defining and maintaining enterprise standards, terminology libraries, or therapeutic area-specific metadata frameworks. Software Developers and Integration Architects
Skilled in building, connecting, or automating; interest in version control, push-pull protocols, and APIs. IT & Infrastructure Stakeholders (IT R&D Managers);
Those who support metadata environments, address access controls, audit trails, system
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