Course Overview

The ethical and lawful handling of patient data is fundamental to clinical research. The GDPR for Clinical Trials and Patients course provides healthcare professionals, researchers, and administrators with a clear understanding of how to manage personal data responsibly and compliantly within the scope of UK and EU data protection law.

Learners will explore the principles of GDPR, patient consent, data processing, and cross-border data transfers, along with incident management and audit procedures. Through real-world scenarios, this course explains how GDPR safeguards patient privacy while enabling essential medical research.

By the end, you’ll be equipped to ensure full compliance throughout the lifecycle of a clinical trial—balancing scientific advancement with patient rights and data security.

Learning Outcomes

• Understand GDPR and its significance in clinical trials.
• Apply the core principles of data protection to research environments.
• Recognise data subject rights and obligations in patient studies.
• Manage consent, processing, and lawful data handling under GDPR.
• Implement data security and incident response procedures.
• Define roles and responsibilities for GDPR compliance in clinical trials.
• Manage international and cross-border data transfer requirements.
• Conduct internal audits and ensure continuous compliance.

Why Choose Us?

Here’s Why This Course is the Best Choice for You:

• Lifetime Access: Revisit course materials anytime, forever.
• Expert Support: Get help from our dedicated tutor team, available Monday to Friday.
• Learn at Your Pace: Study from home, on your schedule, with no pressure.
• Cutting-Edge Content: Access video modules taught by industry-leading instructors.
• 24/7 Assistance: Reach out via email or live chat whenever you need help.
• Multi-Device Access: Learn on your computer, tablet, or smartphone—anywhere, anytime.
• Career-Boosting Certification: Earn a certificate to showcase your skills and enhance your resume.

Assessment

Test Your Knowledge and Earn Your Certification

The course includes interactive quizzes to help you track your progress and reinforce your learning. These quizzes are designed to:

• Identify areas where you need more practice.
• Build confidence in your understanding of the material.
• Prepare you for real-world challenges.

Upon successfully completing the final quiz, you’ll receive a certificate of achievement—a valuable addition to your resume and LinkedIn profile.

Description

Module 01: Introduction to GDPR and Its Relevance to Clinical Trials
Gain an overview of the General Data Protection Regulation (GDPR) and understand its importance in protecting patient confidentiality and data integrity within clinical research.

Module 02: Principles of Data Protection under GDPR
Learn the seven key principles of GDPR—lawfulness, fairness, transparency, purpose limitation, data minimisation, accuracy, storage limitation, and accountability—and how they apply to research data.

Module 03: Data Subject Rights under GDPR in Clinical Trials
Explore patients’ rights to access, rectification, restriction, erasure, and portability of their data, along with lawful exemptions that apply in research contexts.

Module 04: Data Processing and Consent in Clinical Trials
Understand lawful bases for processing patient data, how to obtain valid consent, and how consent interacts with research ethics and clinical governance.

Module 05: Data Security Measures and Incident Management in Clinical Trials
Study best practices for data encryption, anonymisation, and secure storage. Learn how to respond to breaches, conduct risk assessments, and document corrective actions.

Module 06: Roles and Responsibilities in GDPR Compliance for Clinical Trials
Identify the roles of sponsors, investigators, data controllers, and processors. Learn how Data Protection Officers (DPOs) oversee compliance and audit readiness.

Module 07: International Considerations and Cross-Border Data Transfers
Examine GDPR requirements for sharing clinical data outside the UK/EU, including standard contractual clauses (SCCs) and adequacy decisions.

Module 08: GDPR Compliance Monitoring, Audits, and Enforcement in Clinical Trials
Learn how to implement ongoing compliance programmes, conduct internal audits, and understand enforcement mechanisms and penalties for non-compliance.

Career Path

Clinical Research Associate: £30,000 – £50,000
Data Protection Officer: £35,000 – £60,000
Clinical Trial Manager: £40,000 – £65,000
Compliance Specialist: £32,000 – £55,000