GDPR Impact on Data Collection Practices

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Project Overview

In May 2016, the new EU General Data Protection Regulation (GDPR) was released and will become applicable in all member states two years after publication on May 25th, 2018. The GDPR was designed to harmonise data privacy laws across Europe, to protect and empower all EU citizens' data privacy and to reshape the way organisations across the region approach data privacy. An important requirement from the GDPR is the minimisation of collection of personal data on basis of necessity. There are also examples of countries (e.g. France) that are putting local legislation in place regarding collection of personal information and specifically Date of Birth (e.g. France: day of birth cannot be collect in any trial with an FPI after August 14th 2017 except for children aged 0-2 years). The goal of this project is to share experiences and approaches for collecting date of birth and other personal information in compliance with regulations. For example, the project will explore the impact of collecting minimal expected information on Date of Birth: by only collecting Year of Birth (collected) and Age (collected or derived) for standard clinical trials. The project will create a best practices white paper to summarise experiences and recommendations. As the project progresses, it may also explore other general EU regulations and aspects of the GDPR such as the GDPR implies that subjects should be allowed to have their data deleted after it was collected which seems to conflict with CGPs requirement of the need for an audit trail.

Current Sub-teams

Data Collection and PII

Safeguard and Processes

Data Breach

Project Leads

Name Role Organization E-mail
Jean-Marc Ferran Project Lead Qualiance jean-marc.ferran@phuse.eu
Sara Pauwels Project Lead JNJ spauwel2@its.jnj.com
Lauren White Project Assistant PhUSE Lauren@phuse.eu

Project Members

Name Role Organization E-mail
Andreas Schwalm Participant CSL Andreas.Schwalm@cslbehring.com
Arlene Coleman Participant Pfizer arlene.coleman@pfizer.com
Ashwini Weber Participant Amgen ashwinic@amgen.com
Barbara Rusin Participant MMS Holdings brusin@mmsholdings.com
Cordula Massion Participant Analytical-Software cordula.massion@analytical-software.de
Hannah Sharp Participant Gilead Hannah.Sharp@gilead.com
Jean-Marc Ferran WG Lead Qualiance jean-marc.ferran@phuse.eu
Jonathan Andrus Participant Clinicalink Jonathan.Andrus@clinicalink.com
Megan Schmidt Participant UCB Megan.Schmidt@ucb.com
Michelle Brooks Participant Alnylam mbrooks@alnylam.com
Paul Houston Participant CDISC phouston.external@cdisc.org
Rashmi Dodia Participant MMS Holdings rdodia@mmsholdings.com
Shannon Labout Participant CDISC Slabout@cdisc.org
Shital Desai Participant Teradata Shital.Desai@teradata.com
Stephen Bamford Participant Janssen Pharmaceuticals stephen.bamford@phuse.eu

Project Updates

CURRENTLY LOOKING FOR VOLUNTEERS. IF YOU ARE INTERESTED IN JOINING THIS PROJECT PLEASE CONTACT Jean-Marc Ferran - Jean-Marc.Ferran@phuse.eu or Lauren White - lauren@phuse.eu

Objectives and Timelines

List proposed project deliverables and timelines.

Objective Timeline
Project Kick Off and Information Sharing 3-6 Months
White Paper 3 Months
PhUSE team follows up on changing regulations regarding to this topic and regularly compares current regulations with best practices TBD

Project Activities

This section can document project activities or serve as a jumping off point to other pages in the project.

Meeting Minutes


May 24th 2018 Meeting

Archived Content