Deliverables

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.

Year	Working Group	Deliverable Types	Deliverable Format	Title	Status	Links
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
2023	Real World Evidence	Reference	White Paper	Requirements and Recommendations for Regulatory Submissions	Current	WP-074.pdf
2023	Emerging Trends & Technologies	Reference	Poster	Patient Foundations Guide to Starting a Registry	Current	Patient Foundations Guide to Starting a Registry.pdf
2023	Emerging Trends & Technologies	Reference	Poster	Patient Registry Transparency Checklist For Patient Foundations	Current	Patient Registry Transparency Checklist For Patient Foundations.pdf
2023	Emerging Trends & Technologies	Reference	Poster	Myths VS Facts About Patient Registries	Current	Myths VS Facts About Patient Registries.pdf
2023	Optimizing the Use of Data Standards	Regulatory Referenced Deliverable	Template	BDRG V3.0 Package	Current	BDRG+V3.0+Package.zip
2023	Data Visualisation & Open Source Technology	Reference	White Paper	Key Considerations When Understanding Differences in Statistical Methodology Implementations Across Programming Languages – An Introduction to the CAMIS Project	Current	WP077.pdf

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