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. |
End to End RBQM Education – Started Q3 2024 | |
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Project Scope: Provide community forums for presentation and discussion of RBQM-related topics to support industry education. Topics considered include: What are CtQs?, RBQM and Technology, Risk Assessments, Central Monitoring Analytics, QTLs, AI/ML, and RBQM-related change management. | Regular Project Meeting Day/Time:
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Enhancing the Clinical Trial Risk Assessment Process – Started Q2 2024 | |
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Project Scope: We propose beginning this project by identifying CtQ factors via a risk assessment process (characterising risk including assessment and mitigation/risk reduction strategies), which would include identifying trial-level QTLs that support CtQ factors. | Regular Project Meeting Day/Time:
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OpenRBQM: Pre-Competitive Collaboration on Open-Source Software for RBQM – Started Q2 2024 | |
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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. | Regular Project Meeting Day/Time:
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