24th

October

2025

US Connect 2026 – Early Bird Registration is Open!
5 days to go!
Get Involved

28th

October

2025

Safety Analytics Webinar – Registration is Open!
9 days to go!
Get Involved

29th

October

2025

October Webinar Wednesday - Registration is Open!
10 days to go!
Get Involved

16th

November

2025

EU Connect 2025 – Registration is Open!
28 days to go!
Get Involved

21st

February

2026

APAC Connect 2026 – Registration is Open!
125 days to go!
Get Involved

Working Group 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.

Show/hide columns

YearWorking GroupDeliverable TypesDeliverable FormatTitleStatusLinks

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

2025

Optimizing the Use of Data Standards

Reference

White Paper

Implementation of Estimands (ICH E9 (R1)) using Data Standards

Current

2025

Optimizing the Use of Data Standards

Reference

Business Case

Dataset-JSON as Alternative Transport Format for Regulatory Submissions

Current

2025

Data Transparency

Reference

Guideline

PHUSE Good Transparency Practice

Current

2025

Data Transparency

Reference

White Paper

Rare Disease Clinical Data Sharing

Current

2024

Data Transparency

Reference

Blog

EU CTR Update: Year 2 Blog

Current

2024

Real World Evidence

Reference

Poster

Ensuring Registry Data Relevance and Reliability for Regulatory Use

Current

2024

Special Projects

Reference

White Paper

Data Standards White Paper

Current

2024

Risk Based Quality Management

Reference

White Paper

Assessing the Use of Quality Tolerance Limits in the Pharmaceutical Industry

Current

2024

Data Transparency

Reference

Recording

Data Privacy and Data Sharing in Clinical Trials – What Will I Receive and When Will I Receive It?

Current

2024

Real World Evidence

Reference

Blog

Understanding the Data Quality Issues in Real-World Data Through Real-World Examples

Current

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

2024

Safety Analytics

Reference

White Paper

Adverse Event Collection Recommendations

Current

2024

Nonclinical Topics

Reference

Presentation

2024 SEND Survey Results

Current

2024

Optimizing the Use of Data Standards

Reference

White Paper

Dataset-JSON as Alternative Transport Format for Regulatory Submissions

Current

2024

Real World Evidence

Reference

Blog

RWD: The FDA’s Guidance on Assessing Registry Data to Support Regulatory Decision-Making

Current

2024

Safety Analytics

Reference

White Paper

Recommended Definition of Treatment-Emergent Adverse Events in Clinical Trials

Current

2024

Optimizing the Use of Data Standards

Reference

White Paper

Best Practices in Data Standards Implementation Governance

Current

2024

Safety Analytics

Reference

White Paper

Use of Adverse Event Groupings in Clinical Trial Safety Assessments

Current

2024

Real World Evidence

Reference

Blog

Submitting Real World Data: Preliminary Assessment of HL7-FHIR as a Submission Standard

Current

1of9