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Real World Data Autumn Event – Save the Date |
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We’re pleased to announce that the Real World Evidence Working Group will be holding its second multi-day virtual event from 30 September–1 October 2026. Stay tuned for more details and registration information coming soon! |
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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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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 |
Imaging Data Anonymization Guideline |
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The Anonymization of Imaging Data project within the Data Transparency Working Group have published a new white paper: Imaging Data Anonymization Guideline which is now open for public review. The purpose of this guideline is to define the minimum anonymization standards for DICOM imaging data shared externally via a secure, governed research environment (SGRE). This document aims to ensure that all shared clinical trial imaging data complies with privacy regulations and ethical standards, thereby protecting the identities of clinical trial participants. It is intended for people involved in data processing, anonymization, and external collaborations, as well as for external researchers who will access these anonymized data. The team welcome feedback on the paper from 6 January – 3 February. Please send responses to workinggroups@phuse.global |
QC Workflow Optimisation | ||
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The QC Workflow Optimisation project within the Emerging Trends & Innovation Working Group have published a survey exploring the current state of Quality Control across the industry. This survey aims to capture an industry-wide view of current Quality Control practices, how they may need to evolve, and the potential role of emerging technologies such as AI. Your input will help shape future PHUSE discussions, highlight areas for improvement or standardisation, and guide next steps for the QC Workflow Optimisation project. The survey will remain open from 3 December – 14 January. All responses will be collected anonymously.
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The Value of Plain Language Summaries of Trial Results (PLSs) project team within the Data Transparency Working Group, is calling for volunteers! This project has been initiated because whilst the industry has put significant efforts into developing and disseminating plain language summaries of trial results (PLSs) to promote transparency and engagement, there remains a gap in quantitative evidence of how these documents are used and what value they bring to the trial participants and the general public. Gathering feedback from trial participants – the primary audience for PLSs – and other readers will provide meaningful insights into their value and inform improvements. The team will be creating a survey to evaluate the value of PLSs and the survey feedback will be shared as a white paper authored by the group. If you’d like to become a valued project member, please get in touch with workinggroups@phuse.global by 19 January 2026 ahead of the kick off meeting scheduled for Tuesday 20 January 08:00 EST / 13:00 GMT / 14:00 CET. |
The Value of Plain Language Summaries of Trial Results (PLSs) project team within the Data Transparency Working Group, is calling for volunteers! This project has been initiated because whilst the industry has put significant efforts into developing and disseminating plain language summaries of trial results (PLSs) to promote transparency and engagement, there remains a gap in quantitative evidence of how these documents are used and what value they bring to the trial participants and the general public. Gathering feedback from trial participants – the primary audience for PLSs – and other readers will provide meaningful insights into their value and inform improvements. The team will be creating a survey to evaluate the value of PLSs and the survey feedback will be shared as a white paper authored by the group. If you’d like to become a valued project member, please get in touch with workinggroups@phuse.global by 19 January 2026 ahead of the kick off meeting scheduled for Tuesday 20 January 08:00 EST / 13:00 GMT / 14:00 CET. |
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