1. Data Transparency Safeguard and Processes Working Group
Arlene Coleman, Hannah Sharp, Ashwini Weber, Jean-Marc Ferran, Michelle Brooks, Megan Schmidt

2. Safeguard and Process Categories
Process, documentation and communication between CRO’s and Sponsors
GDPR requirement implications for past, ongoing and future studies
Other country regulations on data transparency and communications
Long term approach for archiving and storing data
Non-TMF study documentation clean-up process    
Data sharing activities

3. Safeguard and Process Status Update
Current team members collecting information for each assigned category
Re-evaluate current categories
Additional volunteers needed
GOAL:
White paper completion to outline safeguard and process recommendations for GDPR compliancy

4. Contact:
Lauren White
Arlene Coleman
Questions?