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2024

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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.

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YearWorking GroupDeliverable TypesDeliverable FormatTitleStatusLinks

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

2023

Real World Evidence

Reference

White Paper

Requirements and Recommendations for Regulatory Submissions

Current

2023

Emerging Trends & Technologies

Reference

Poster

Patient Foundations Guide to Starting a Registry

Current

2023

Emerging Trends & Technologies

Reference

Poster

Patient Registry Transparency Checklist For Patient Foundations

Current

2023

Emerging Trends & Technologies

Reference

Poster

Myths VS Facts About Patient Registries

Current

2023

Optimizing the Use of Data Standards

Regulatory Referenced Deliverable

Template

BDRG V3.0 Package

Current

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

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