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Industry recommendations for Risk Based Quality Management in First in Human and Small Clinical Trials |
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The Enhanced Risk-based Quality Management (RBQM) Approaches for First-in-Human and/or Small Clinical Trials project within the Risk Based Quality Management Working Group have published a new white paper: Industry recommendations for Risk Based Quality Management in First in Human and Small Clinical Trials which is now open for public review. The purpose of this white paper is to provide guidance on the application of Risk-Based Quality Management (RBQM) in First-in-Human (FIH) and small clinical trials. This document aims to support sponsors in adopting risk-proportionate, efficient quality oversight approaches while maintaining patient safety and data integrity. It is intended for clinical operations, quality, and oversight teams involved in the design, conduct, and monitoring of small clinical trials. The team welcome feedback on the paper from 9 January – 6 17 February. Please send responses to workinggroups@phuse.global. |
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