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The Working Groups Q2 Reports have now been published. Take a look at what our Working Groups have been working on this quarter, along with the events that have taken place.

The Enhancing the Clinical Trial Risk Assessment Process project within the Risk Based Quality Management Working Group has produced a White Paper ‘Enhancing Clinical Trial Risk Assessment: From Compliance to Quality-driven Collaboration’. This white paper provides practical guidance for transforming clinical trial risk assessment from a compliance-driven activity into a collaborative, quality-focused process. It presents a six-step framework aligned with ICH E6(R3) and E8(R1), helping teams identify Critical-to-Quality factors, manage risks proportionately, strengthen cross-functional collaboration, and leverage AI to improve the consistency and effectiveness of risk management throughout the study lifecycle.

Please provide your comments by emailing workinggroups@phuse.global. Closing date for comments: 27 August 2026.

The Comparing Analysis Method Implementations in Software (CAMIS) project within the Data Visualisation and Open Source Technology Working Group has published a new Blog titled, Comparison of GLMMs and GEEs for Categorical Endpoints.

This blog discusses a recent PHUSE CAMIS contribution, developed in collaboration with the PSI AIMS SIG, that explored the implementation of generalised linear mixed models (GLMMs) and generalised estimating equations (GEEs) in R and SAS, and compared the software implementations of each method.

The Anonymisation of Imaging Data project within the Data Transparency Working Group has published a new White Paper titled Imaging Data Anonymisation Guideline.

This white paper provides practical recommendations for anonymising DICOM imaging data shared with external researchers. It addresses the removal of identifiable information from both metadata and pixel content while maintaining research value. Based on industry standards and regulatory guidance, the paper outlines anonymisation approaches, pixel data considerations, and risk-based strategies to support secure, compliant and reproducible data sharing.

The Quality Tolerance Limits – Threshold Setting Methodologies project within the Risk Based Quality Management Working Group is preparing for its upcoming Webinar 'Risk Based Quality Management Webinar: Action Limits as an Early Warning System within a QTL Monitoring Strategy', taking place 1 September 2026 at 10:30-11:30 (EDT) / 15:30-16:30 (BST) / 16:30-17:30 (CEST).

This session will explore how action limits can serve as an early-warning mechanism within QTL monitoring, helping clinical trial teams detect emerging risks sooner, investigate and respond before thresholds are breached, and support more proactive, informed risk-based quality management.

The Data Transparency Working Group is preparing for its upcoming multi‑day virtual event, taking place 15–17 September 2026 at 10:00–12:30 (EDT) / 15:00–17:30 (BST) / 16:00–18:30 (CEST).

The event will focus on the evolving landscape of clinical data transparency, including approaches to data sharing, anonymisation, governance and enabling responsible access to clinical data.

The Real World Evidence Working Group is preparing for its upcoming multi‑day virtual event, taking place 30 September–1 October 2026 at 09:00–11:30 (EDT), 14:00–16:30 (BST), and 15:00–17:30 (CEST).

Join the PHUSE Community to explore the evolving landscape of real-world data (RWD), including its growing role in clinical research and regulatory decision-making. This event will bring together global experts to share insights, practical approaches, and real-world applications of RWD.