Working Group Deliverables

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

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

Dataset-JSON as Alternative Transport Format for Regulatory Submissions

PHUSE Good Transparency Practice

Rare Disease Clinical Data Sharing

EU CTR Update: Year 2 Blog

Ensuring Registry Data Relevance and Reliability for Regulatory Use

Data Standards White Paper

Assessing the Use of Quality Tolerance Limits in the Pharmaceutical Industry

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

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

Considerations for the Use of Real-World Data and Real-World Evidence to Support Regulatory Decision-Making for Drug and Biological Products

Adverse Event Collection Recommendations

2024 SEND Survey Results

Dataset-JSON as Alternative Transport Format for Regulatory Submissions

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

Recommended Definition of Treatment-Emergent Adverse Events in Clinical Trials

Best Practices in Data Standards Implementation Governance

Use of Adverse Event Groupings in Clinical Trial Safety Assessments

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