Clinical trials; if you are the Sponsor,
you are the Data Controller
June 4, 2018
This Regulation applies to the processing of personal data of data subjects who are in the Union by a controller or processor not established in the Union, where the processing activities are related to: the offering of goods or services, irrespective of whether a payment of the data subject is required, to such data subjects in the Union; or the monitoring of their behavior as far as their behavior takes place within the Union.”.
1.As Data Controller you must demonstrate accountability by:
2.Following the GDPR principles
3.Allowing subjects to exercise their rights
4.Maintaining records of data processing activities
5.Performing a DPIA (a clinical study is considered critical for the subject’s rights and freedom)
6.Appointing a DPO
7.Appointing an EU Representative
8.Following the rules of transfer
Happy to share experience while at the Bio Convention. Get in touch.
Xavier Gobert, Nicole Renesonnet