Final deliverables and references from Working Groups Projects can be found in this section of the website. Use the filters to narrow down your search.
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| Year | Working Group | Deliverable Types | Deliverable Format | Title | Status | Links |
|---|---|---|---|---|---|---|
2025 | Safety Analytics | Reference | White Paper | Recommendations for Analyses and Displays Associated with Hepatotoxicity with a Focus on Phase 2–4 Clinical Trials and Integrated Submission Documents Stage 1: Initial Assessment and Screening for Potential for Hepatotoxicity | Current | WP091.pdf |
2025 | Optimizing the Use of Data Standards | Reference | White Paper | Implementation of Estimands (ICH E9 (R1)) using Data Standards | Current | WP-92 Implementation of Estimands (ICH E9 (R1)) using Data Standards.pdfWP-92 Implementation of Estimands (ICH E9 (R1)) using Data Standards-Example Document.pdf |
2025 | Optimizing the Use of Data Standards | Reference | Business Case | Dataset-JSON as Alternative Transport Format for Regulatory Submissions | Current | https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Optimizing+the+Use+of+Data+Standards/Dataset+JSON+Business+Case_Final.pdf |
2025 | Data Transparency | Reference | Guideline | PHUSE Good Transparency Practice | Current | https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Data+Transparency/WP-080.pdf |
2025 | Data Transparency | Reference | White Paper | Rare Disease Clinical Data Sharing | Current | https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Data+Transparency/WP-095.pdf |
2024 | Data Transparency | Reference | Blog | EU CTR Update: Year 2 Blog | Current | https://phuse.global/Communications/PHUSE_Blog/eu-ctr-update-year-2 |
2024 | Real World Evidence | Reference | Poster | Ensuring Registry Data Relevance and Reliability for Regulatory Use | Current | Ensuring+Registry+Data+Relevance+and+Reliability+for+Regulatory+Use.pdf |
2024 | Special Projects | Reference | White Paper | Data Standards White Paper | Current | WP086.pdf |
2024 | Risk Based Quality Management | Reference | White Paper | Assessing the Use of Quality Tolerance Limits in the Pharmaceutical Industry | Current | WP-084.pdf |
2024 | Data Transparency | Reference | Recording | Data Privacy and Data Sharing in Clinical Trials – What Will I Receive and When Will I Receive It? | Current | https://www.youtube.com/watch?v=cyk2DJuazB8 |
2024 | Real World Evidence | Reference | Blog | Understanding the Data Quality Issues in Real-World Data Through Real-World Examples | Current | https://phuse.global/Communications/PHUSE_Blog/understanding-the-data-quality-issues-in-real-world-data-through-real-world-examples |
2024 | Real World Evidence | Reference | Blog | Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products | Current | https://phuse.global/Communications/PHUSE_Blog/considerations-for-the-use-of-real-world-data-and-real-world-evidence-to-support-regulatory-decision-making-for-drug-and-biological-products |
2024 | Safety Analytics | Reference | White Paper | Adverse Event Collection Recommendations | Current | WP83+AE+Collection.pdf |
2024 | Nonclinical Topics | Reference | Presentation | 2024 SEND Survey Results | Current | 2024+SEND+Survey+Results.pdf |
2024 | Optimizing the Use of Data Standards | Reference | White Paper | Dataset-JSON as Alternative Transport Format for Regulatory Submissions | Current | WP-88+Dataset-JSON+Report.pdf |
2024 | Real World Evidence | Reference | Blog | RWD: The FDA’s Guidance on Assessing Registry Data to Support Regulatory Decision-Making | Current | https://phuse.global/Communications/PHUSE_Blog/rwd-the-fda-s-guidance-on-assessing-registry-data-to-support-regulatory-decision-making |
2024 | Safety Analytics | Reference | White Paper | Recommended Definition of Treatment-Emergent Adverse Events in Clinical Trials | Current | WP-087+Recommended+Definition+of++Treatment-Emergent+Adverse+Events+in+Clinical+Trials+.pdf |
2024 | Optimizing the Use of Data Standards | Reference | White Paper | Best Practices in Data Standards Implementation Governance | Current | WP-89.pdf |
2024 | Safety Analytics | Reference | White Paper | Use of Adverse Event Groupings in Clinical Trial Safety Assessments | Current | https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Safety+Analytics/WP-090%2BAEGiS.pdf |
2024 | Real World Evidence | Reference | Blog | Submitting Real World Data: Preliminary Assessment of HL7-FHIR as a Submission Standard | Current | https://phuse.global/Communications/PHUSE_Blog/submitting-real-world-data-preliminary-assessment-of-hl-7-fhir-as-a-submission-standard |
