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 arlene.coleman@pfizer.com

Project Participants

Name Role Organization E-mail
Ashwini Weber Participant Amgen ashwinic@amgen.com
Hannah Sharp Participant Gilead Hannah.Sharp@gilead.com
Margi Sheth Participant Astrazeneca margi.sheth@astrazeneca.com
Megan Schmidt Participant UCB Megan.Schmidt@ucb.com
Michelle Brooks Participant Alnylam mbrooks@alnylam.com
Jean-Marc Ferran Project Lead Qualiance jean-marc.ferran@phuse.eu

Project Updates


Objectives and Timelines

List proposed project deliverables and timelines.

Objective Timeline

Project Activities


August 15th Meeting Presentation