GDPR: Legal Basis in Clinical Research


Explicit consent is often used as legal basis for the processing of any trial related personal data. However, if local legislation does not mandate this, other options are available.  Based on the ‘European Data Protection Board Opinion 3/2019’ recommendations, this 30’session explains which legal basis can and cannot be selected for the processing of (sensitive) personal data for clinical trial purposes. Because of the direct link between legal basis and data subject rights, it is important to choose it wisely for both subject protection, compliance and research purposes.

Learning objectives

By the end of this TRIUM Training you should be able to:

  • Explain different interpretations of GDPR in the EEA member states are possible
  • Explain the different legal basis for the collection of special categories of personal data
  • List updates and lessons learned since the launch of GDPR on May 25, 2018
Intended audience

Fundamental Level
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.

Esther Daemen
Esther Daemen has over 27 years of working experience in the healthcare/pharma & device field. She served many organizations in different research roles and as professional development director at ACRP global. She gained a bachelor’s in nursing and earned project management, training and DPO certificates as well as and a master´s degree in Business. Esther is also a highly sought-after presenter at professional conferences/universities and a writer of peer-reviewed articles for professional magazines like ‘The Clinical Researcher’. Her work was rewarded by the KP Morgan 'OECT Summit 10Years Speaker Achievement Award' in 2020, the ‘Best trainer to watch’ 2010 Training Magazine award and by having her organization ‘Kendle’ being listed as one of the top 125 training providers in the world in 2008. "TRIUM is an expert Contract Research Organization that offers a unique combination of global CRO services, staffing solutions, quality services, GDPR consultancy and risk-based approaches as well as training services. It’s our mission to be a passionate, dedicated business partner with a focus on excellence to provide start‐to‐finish clinical trial activities tailored to the timing, budget and specific needs of the Sponsor.”