OpenRBQM: Pre-Competitive Collaboration on Open-Source Software for RBQM
Problem Description |
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Risk-based quality management (RBQM) is a regulatory-recommended approach for identifying and managing clinical trial risks. While extensive literature describes RBQM best practices, there are limited publicly available open-source tools; most implementations rely on commercial or organisation-specific solutions. This project proposes establishing an Open-Source RBQM Working Group alongside a dedicated development team. The Working Group will provide a cross-functional forum to explore and guide open-source RBQM initiatives. Activities will include discussions on software best practices, design input for development outputs, and demonstrations of emerging tools. The RBQM Development Team will focus on pre-competitive co-development of centralised monitoring tools, primarily using R, with flexibility to explore additional technologies. Initial work will centre on reports and interactive visualisations for statistical monitoring, such as digit preference, missing data, and fraud detection analyses. Development will be managed via GitHub, with regular collaborative meetings. |
Project Leads | |
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Jeremy Howells, Roche | |
Jeremy Wildfire, Gilead | |
Natalia Andriychuk, Gilead | |
Alex Pearce, PHUSE Project Coordinator |
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