Risk Based Quality Management – Project Volunteer Board
Welcome! |
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Interested in joining one of the Risk Based Quality Management Group Projects? The projects below welcome new volunteers. |
Project Description: This initiative will provide Community Forums to present and discuss RBQM-related topics, supporting broader industry education. Planned topics include CtQs, RBQM and technology, risk assessments, central monitoring analytics, QTLs, AI/ML, and change management. There remains a significant need for foundational RBQM education across the industry, including its core components and effective implementation. In addition, limited regulatory feedback, particularly from the FDA, has contributed to uncertainty, highlighting an opportunity for collaborative educational efforts. Misconceptions and lack of understanding have delayed adoption within many organisations. Although RBQM approaches can improve data quality and operational efficiency across functions such as data management, medical monitoring and clinical operations, these benefits are not fully realised due to hesitancy in applying risk-based methods. These forums aim to address knowledge gaps, encourage engagement, and support more consistent adoption of RBQM practices. | Regular Project Meeting Day/Time:
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OpenRBQM: Pre-Competitive Collaboration on Open-Source Software for RBQM – Started Q2 2024 | |
Project Description: 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. | Regular Project Meeting Day/Time:
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