1. Data Transparency CSS 2018 Webinar 25.April 2018
Jean-Marc Ferran (Qualiance)
PhUSE Data Transparency WG Lead

2. PhUSE Data Transparency WG 2018 Projects
NEW
GDPR
Policy, Guidance and Material Reviews
Data De-Identification standard
Policy 0070 Interpretations
Data Transparency Roadmap
Data Sharing Processes
Policy 0070 Submissions Review
PhUSE Standard for SDTM
DT Roadmap Visual
De-Identification Automation & Risk Analysis
PhUSE Standard for ADaM
Narratives
DT Roadmap White Paper
Anonymization of Imaging Data
Date Offset Methodology
Data Utility
Handling of ”Highly” Re-identifying Data
Risk Framework
Risk CSR

4. FDA’s CSR Disclosure Pilot Presentation by Ann Witt (FDA)
Presentation and Q&A with Ann Witt (FDA)
Discuss differences with EMA and Health Canada Data Sharing Initiatives

5. Data Transparency Roadmap
Review of Visual
Feedback on White Paper Structure
Collaboration Best Poster Award

6. Narratives and Data Utility
Discuss White paper on Reactive Approach
Discuss Pro-active Approach and Process/Organizational Impact and Changes
Define Business Requirements of an Industry Solution to tackle Reactive Anonymization of CSR that is Policy 0070 Compliant
Data Utility
Define Qualitative and Quantitative Scale to measure Data Utility in Anonymized CSRs

7. Next Steps Finalize and Publish: Data Transparency Roadmap Visual
Data Transparency Roadmap White Paper
Narratives White Paper
Data Utility Scales
Overview and Comparison of EMA, Health Canada and FDA Data Sharing initiatives

8. Thanks