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A couple of the Working Groups have expanded, with two new projects this quarter: 

• Real World Evidence has Estimands for RWD/RWE.
• Risk Based Quality Management has Enhanced Risk-Based Quality Management (RBQM) Approaches for First-in-Human and/or Small Clinical Trials.

It’s been another busy quarter across all eight Working Groups. There have been eight published deliverables, with many more in the works. The published deliverables are: 

Data Standards White Paper 

• The white paper was authored by members of the PHUSE data standards community, comprised of leaders and experts responsible for the governance and implementation of data standards across the biopharmaceutical industry.  

Ensuring Registry Data Relevance and Reliability for Regulatory Use  

• The Best Data Practices for Rare Disease Patient Foundations and Researcher within the Real World Evidence Working Group published a new deliverable. The poster – ‘Ensuring Registry Data Relevance and Reliability for Regulatory Use’ – focuses on data governance, integrity, fit-for-purpose data, and security/privacy. 

EU CTR Blog – Year 2 Update 

• The EU CTR Implementation project within the Data Transparency Working Group posted a blog post on EU CTR implementation. 
  The European Union (EU) Clinical Trials Regulation No 536/2014 (‘the Regulation’) has been operational since 31 January 2022. It covers interventional clinical trials of investigational medicinal products for human use and has important impacts on all aspects of trial set-up, operation and reporting in the EU and European Economic Area (EEA). 

QTL White Paper  

• The Quality Tolerance Limits project within the Risk Based Quality Management Working Group have published a new deliverable, a white paper on Assessing the Use of Quality Tolerance Limits in the Pharmaceutical Industry. This white paper aims to provide the reader with valuable insights into the depth and breadth of the use of QTLs and address how QTLs are used in a wider scope of implementing RBQM. Following all their hard work, the project is now closing out. 

Educate the General Population on Data Privacy and Data Sharing 

• The Educate the General Population on Data Privacy and Data Sharing project within the Data Transparency Working Group have published video 2: ‘What Will I Receive and When Will I Receive It?’  

SDTM ADaM Implementation FAQ  

• The team have published a new FAQ within Validation/Conformance Rules and they continue to receive and work through more FAQs. 

The Quality and Reusability of Real World Data project within the Real World Evidence Working Group has published two new blog posts.

• The Understanding the Data Quality Issues in Real-World Data Through Real-World Examples blog post takes a closer look at the experiences shared within the Working Group of the types of data quality hurdles encountered when using real-world data (RWD).
• The Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products blog post explores the use of real-world evidence (RWE) as a powerful tool for informing regulatory decisions and advancing medical innovation.