Working Groups Report – Q3 2025

Three Working Groups initiated a new project this quarter:

Building a Better MDR, a new project within the Optimizing the Use of Data Standards Working Group, aims to define a fit-for-purpose MDR in today’s data landscape. The resultant goal is a white paper informed by perspectives across the data life cycle.

The goal of Applying Advanced Data Privacy Methods to Real World Data (RWD), a new project within the Real World Evidence Working Group, is to develop a comprehensive, cross-disciplinary resource to support individuals and organisations in applying advanced privacy-preserving techniques to real-world data (RWD).

The PHUSE Stakeholder Review of ISRCTN Results System Prototype project under the Data Transparency Working Group are extending their work and have a new opportunity to provide feedback on the ISRCTN Results System Prototype. This new registry is designed to align with World Health Organization (WHO) data requirements and UK clinical trial regulations, making results submission easier, more flexible and more accurate, while ensuring access and re-use of trial results.

Three Working Group projects published deliverables in quarter 3:

The Good Transparency Practices project within the Data Transparency Working Group have published a new white paper. Good Transparency Practice (GTP) is a guideline to create a set of best practices to govern the anonymisation of clinical trial data, for external sharing or disclosure. Although there are transparency initiatives across the globe, with differing guidelines, the common goal is to uphold patient privacy and data utility to the highest standards.

The Rare Disease/Small Population Data Sharing project within the Data Transparency Working Group have published a new white paper. The purpose is to review potential barriers to the sharing of rare disease data, such as risk of re-identification and invasion of privacy (balanced against maintaining data utility), to understand if and how these barriers apply to controlled access data sharing under specific contextual assumptions.

The SDTM ADaM Implementation FAQ project within the Optimizing the Use of Data Standards Working Group have published a new response to a question regarding SDTM/ADaM IG Nuances. View the team’s response here.

The Cloud Adoption in the Life Sciences Industry project within the Emerging Trends & Innovation Working Group have produced a white paper, Cloud Services, A Framework for Adoption in the Regulated Life Sciences Industry.

The Risk Based Quality Management Working Group have produced a survey to gain insight into how companies across the industry are implementing SDR and SDV in sites in China.

• Rare Disease/Small Population Data Sharing 

• Good Transparency Practices