...
Real World Data Autumn Event – Save the Date |
|---|
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! |
...
Industry recommendations for Risk Based Quality Management in First in Human and Small Clinical Trials |
|---|
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 |
|---|
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 |
...