OpenRBQM: Pre-Competitive Collaboration on Open-Source Software for RBQM
Problem Statement |
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Risk-based quality management (RBQM) is a regulatory-recommended approach to detect and effectively manage risk in a clinical trial. While there is a significant body of literature describing RBQM implementation and best practices (1, 2), there are few publicly available open-source tools for RBQM available. Instead, commercial tools and custom company-specific RBQM implementations currently serve as the industry standard for RBQM implementation. |
Project Scope |
We propose forming an Open-Source RBQM Working Group and an associated development sub-team. Open-Source RBQM Working Group – A Working group that will discuss open-source projects related to RBQM. This will be a cross-functional team that will consider how open-source solutions can be developed using RBQM best practices. Monthly meetings will include discussion of RBQM software best practices, design discussions for development team deliverables and demos of RBQM tools developed. RBQM Development Team – This team will focus on the pre-competitive co-development of RBQM centralised monitoring tools. The primary focus will be on R package development, though other technologies may be considered. The team will start with a focus on creating reports and interactive graphics related to centralised statistical monitoring (e.g. digit preference charts, missing data analysis, fraud detection). All development will be done using GitHub. The team will meet every other week in 2024. |
Project Leads | |
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Jeremy Howells, Roche | |
Jeremy Wildfire, Gilead | |
Natalia Andriychuk, Gilead | |
Alex Pearce, PHUSE Project Coordinator |
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