GDPR & Data Protection in Clinical Trials
Chapter 3

GDPR & Data Protection in Clinical Trials

31/03/2026

Course Description


Build practical GDPR expertise for clinical research. Reduce risk. Ensure compliance.

GDPR & Data Protection in Clinical Trials is a practical training designed to help clinical research teams understand and apply GDPR requirements throughout the full lifecycle of a clinical trial. It is suitable for professionals involved in clinical operations, study management, vendor oversight, regulatory affairs, and leadership who handle personal data as part of clinical research activities.

The course explains how GDPR applies specifically in the context of clinical trials, from study design and site selection to vendor management, international data transfers, and ongoing oversight. It focuses on real operational scenarios, helping teams understand roles, responsibilities, and practical actions required to maintain compliance. The training is supported by a downloadable companion e-book and includes a certificate of completion. 

Course Modules
  • Module 1: Controller, Data Protection Officer, and Data Protection Representative
  • Module 2: Clinical Trial Protocol and GDPR Language
  • Module 3: Investigator and Site Selection
  • Module 4: ICF Revisions and Transparency Obligations
  • Module 5: Clinical Trial Agreements and GDPR
  • Module 6: Notifications and Registrations with Data Protection Authorities
  • Module 7: Vendor Oversight & Data Security
  • Module 8: Cross-Border Transfers under the GDPR
  • Module 9: GDPR Assessments for Clinical Trials
  • Module 10: Ongoing GDPR Oversight and Escalation


Who this course is for
  • Clinical Operations and Study Management teams
  • Professionals involved in clinical trials and research activities
  • Regulatory Affairs, Quality, and Compliance teams
  • Vendor Management and Outsourcing teams
  • Organizations conducting clinical trials in the EU, EEA, or UK