OpenRBQM

Open-source software for risk-based quality management (RBQM) in clinical trials โ€” a PHUSE pre-competitive collaboration.

OpenRBQM: Pre-Competitive Collaboration on Open-Source Software for RBQM

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๐Ÿ“ฆ Packages

The OpenRBQM ecosystem of open-source R packages.

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๐Ÿ—‚๏ธ Vignettes

Package vignettes and documentation.

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๐Ÿ“ฐ Outreach

Publications, presentations, and project updates.

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๐Ÿ’ฌ News

Release notes for OpenRBQM packages, grouped by quarter.

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โ“ Getting Started

Get started, find answers, and learn how to contribute.

Get started โ†’

๐Ÿ‘ฅ Tech Team Meetings

Slides and notes from OpenRBQM tech team meetings.

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Problem Statement

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.