GDPR Impact on Data Collection Practices
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.
Data Collection and PII
Safeguard and Processes
|Jean-Marc Ferran||Project Lead||Qualiancefirstname.lastname@example.org|
|Sara Pauwels||Project Lead||JNJemail@example.com|
|Lauren White||Project Assistant||PhUSE||Lauren@phuse.eu|
|Barbara Rusin||Participant||MMS Holdingsfirstname.lastname@example.org|
|Jean-Marc Ferran||WG Lead||Qualianceemail@example.com|
|Rashmi Dodia||Participant||MMS Holdingsfirstname.lastname@example.org|
|Stephen Bamford||Participant||Janssen Pharmaceuticalsemail@example.com|
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 - firstname.lastname@example.org
Objectives and Timelines
List proposed project deliverables and timelines.
|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|
This section can document project activities or serve as a jumping off point to other pages in the project.