Deliverables

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

Requirements and Recommendations for Regulatory Submissions

Patient Foundations Guide to Starting a Registry

Patient Registry Transparency Checklist For Patient Foundations

Myths VS Facts About Patient Registries

BDRG V3.0 Package

Key Considerations When Understanding Differences in Statistical Methodology Implementations Across Programming Languages – An Introduction to the CAMIS Project