Working Group Deliverables

Find a range of deliverables from the PHUSE Working Groups Projects here, from peer-reviewed white papers to educational videos. Use the filters to narrow your search.

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.pdf WP-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
2025	Data Transparency	Reference	Regulatory Response	Feedback on the MHRA Clinical Trials Regulation Guidance	Current	https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Data+Transparency/INFO-014.pdf
2025	Data Transparency	Reference	Regulatory Response	Summary of the PHUSE Data Transparency Working Group’s Feedback Submitted Online Via Prototype	Current	https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Data+Transparency/INFO-016.pdf
2025	Optimising the Use of Data Standards	Reference	FAQ	Optimizing the Use of Data Standards – Frequently Asked Questions – Data Submission 001	Current	https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Optimizing+the+Use+of+Data+Standards/FAQ-001.pdf
2025	Optimising the Use of Data Standards	Reference	FAQ	Optimizing the Use of Data Standards – Frequently Asked Questions – Data Submission 002	Current	https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Optimizing+the+Use+of+Data+Standards/FAQ-002.pdf
2025	Optimising the Use of Data Standards	Reference	FAQ	Optimizing the Use of Data Standards – Frequently Asked Questions – SDTM/ADaM Harmonisation	Current	https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Optimizing+the+Use+of+Data+Standards/FAQ-003.pdf
2025	Optimising the Use of Data Standards	Reference	FAQ	Optimizing the Use of Data Standards – Frequently Asked Questions – SDTM/ADaM IG Nuances	Current	https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Optimizing+the+Use+of+Data+Standards/FAQ-004.pdf
2025	Optimising the Use of Data Standards	Reference	FAQ	Optimizing the Use of Data Standards – Frequently Asked Questions – Imputing Partial Dates	Current	https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Optimizing+the+Use+of+Data+Standards/FAQ-005.pdf
2025	Optimising the Use of Data Standards	Reference	FAQ	Optimizing the Use of Data Standards – Frequently Asked Questions – Trial, Design, Domain	Current	https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Optimizing+the+Use+of+Data+Standards/FAQ-006.pdf
2025	Optimising the Use of Data Standards	Reference	FAQ	Optimizing the Use of Data Standards – Frequently Asked Questions – Validation/Conformance Rules	Current	https://phuse.s3.eu-central-1.amazonaws.com/Deliverables/Optimizing+the+Use+of+Data+Standards/FAQ-007.pdf
2025	Emerging Trends & Innovation	Reference	White Paper	Cloud Services: A Framework for Adoption in the Regulated Life Sciences Industry	Current	WP-097.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

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