Safeguard and Processes

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Project Overview

As part of the wider GDPR this sub-team is looking to focus on;

  • Dates collected in EDC to do lab ranges and not communicated to sponsor
  • Back and forth between CRO and Sponsors, DM and PV, etc.
  • Implications for Past/Ongoing/Future studies wrt GDPR requirements
  • MR-001/MR-002, French regulations on email communications about data
  • Keep data forever or anonymize or delete after 25 years + non-TMD study documents clean-up process?

Project Leads

Name Role Organisation E-mail
Arlene Coleman Participant Pfizer

Project Participants

Name Role Organization E-mail
Ashwini Weber Participant Amgen
Hannah Sharp Participant Gilead
Margi Sheth Participant Astrazeneca
Megan Schmidt Participant UCB
Michelle Brooks Participant Alnylam
Jean-Marc Ferran Project Lead Qualiance

Project Updates

Objectives and Timelines

List proposed project deliverables and timelines.

Objective Timeline

Project Activities

August 15th Meeting Presentation