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About

This course provides a deeper focus on Article 9(2)(j) research exemptions and pseudonymisation vs anonymisation standards. It covers international data transfers, privacy by design, and complex scenarios like pharmacovigilance and biobanking. Learners also study breach reporting, dual EU–UK GDPR compliance, and documentation practices. It builds practical skills for DPOs and research staff to ensure audit readiness and participant data protection.

Course Syllabus

  1. The Origins, Scope, and Enforcement of the World's Most Influential Data Protection Law
  2. Where the Clinical Trials Regulation and GDPR Intersect — and Where They Conflict
  3. Managing the Fundamental Tension Between Trial Data Retention and Privacy Rights
  4. The Core Legal Framework That Governs Health Data Processing in Clinical Research
  5. Personal Data, Special Categories, Roles, and Accountability in Clinical Research
  6. Demonstrating GDPR Compliance — Not Just Claiming It

  1. GDPR in the Clinical Trial Ecosystem
  2. Records of Processing Activities (ROPA)
  3. GDPR Consent vs GCP Consent
  4. Privacy Notices in Clinical Trials
  5. Data Subject Rights in Clinical Trials
  6. Purpose Limitation in Clinical Trials

  1. DPIA
  2. Article 32 — Data Security
  3. Anonymisation in Research
  4. Data Retention & Deletion
  5. Pharmacovigilance & GDPR
  6. Vendor & Processor Security

  1. International Data Transfers
  2. UK GDPR & Post-Brexit Transfers
  3. Breach Notification
  4. DPO & Supervisory Authorities
  5. The Global Privacy Landscape
  6. Course Wrap-Up

Our Certified Customers

novartis
NHS
takeda
roche
baxter

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RC

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Frequently Asked Questions

The GDPR for Pharmaceuticals and Clinical Trials course by Whitehall Training explains how GDPR applies to clinical research. It covers key principles, lawful bases (Articles 6 & 9), and handling sensitive health data. The course also explores roles in trials, data subject rights, and compliance tools like DPIAs and ROPA. It prepares professionals to manage data securely and meet regulatory requirements.

  • The fundamentals of GDPR, its legislative background, and its relevance to clinical trials and life sciences
  • The seven core GDPR principles and how they apply to clinical research data
  • Lawful bases for data processing under Article 6 and special category data requirements under Article 9
  • Roles and responsibilities of data controllers, processors, and other stakeholders in clinical trials
  • How GDPR aligns and interacts with GCP and Clinical Trials Regulation (CTR) requirements
  • Data subject rights and how they are managed within a clinical research context
  • Key concepts such as pseudonymisation, anonymisation, and data minimisation in trial data handling
  • Accountability requirements including ROPA, DPIA, and data protection by design in clinical trials

This course is ideal for individuals who want to build or strengthen their understanding of GDPR in clinical research and pharmaceutical environments, including:

  • Clinical research professionals working with trial data and patient information
  • Clinical Research Associates (CRAs) and Clinical Research Coordinators (CRCs) handling site data and monitoring activities
  • Professionals in pharmaceutical, biotech, or CRO organizations involved in data processing and compliance
  • Data management, regulatory, and pharmacovigilance professionals dealing with sensitive health data
  • Anyone seeking a strong foundation in GDPR principles, data protection, and clinical trial compliance .

  • Comprehensive, industry-relevant training on GDPR in pharmaceuticals and clinical trials
  • Aligned with current regulatory frameworks including GDPR, CTR, and GCP requirements
  • Enhances understanding of handling sensitive health data in compliance with global standards
  • Practical, scenario-based insights into real-world data protection challenges in clinical research
  • Certificate issued upon successful completion