Data Transparency Safeguard and Processes Working Group Arlene Coleman, Hannah Sharp, Ashwini Weber, Jean-Marc Ferran, Michelle Brooks, Megan Schmidt
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 email communications Long term approach for archiving and storing data Non-TMF study documentation clean-up process Data sharing activities
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
Contact: Lauren White (lauren@phuse.eu) Arlene Coleman (arlene.coleman@pfizer.com) Questions?