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Optimizing the Use of Data Standards |
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The SDTM ADaM Implementation FAQ project within the Optimizing the Use of Data StandardsWorking Group has published a new response to a question regarding SDTM/ADaM IG Nuances. View the team's response to the following question here. ‘CTCAE Upversioning – When should a sponsor organisation decide to upversion CTCAE, DAIDS, or any other toxicity grading standards? How should sponsors handle pooled analyses with varying grading scales?' Do you have a (FAQ project based) question? Send your questions to the team by emailing workinggroups@phuse.global. |
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Capturing Computational Workflows in Clinical Trials with BioCompute |
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The Integration of Omics Data into Clinical Drug Development project within the Emerging Trends & Innovation Working Group have published a new white paper: Capturing Computational Workflows in Clinical Trials with BioCompute which is now open for public review. This white paper explores how the BioCompute standard is being applied in real-world clinical trials, showcasing practical case studies that demonstrate its role in improving reproducibility, transparency, and regulatory communication across complex computational workflows. The team welcome feedback on the paper from 23 January – 20 February. Please send responses to workinggroups@phuse.global. |
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 February. Please send responses to workinggroups@phuse.global. |
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