ONLINE CERTIFICATE COURSE

  • Course length

    Approximately 2 weeks

  • For whom is the course appropriate?

    The course is appropriate for anyone in the field of clinical trials who will be working on GDPR implementation.

  • 8 units of study

    Course curriculum below

What you'll learn

  • ● You will understand what the General Data Protection Regulation (GDPR) is

  • ● You will learn the 'Lawful Basis' Requirements for GDPR

  • ● You will learn about data security under GDPR

  • ● You will learn about patient centricity and data protection

  • ● You will learn about the DPA - data protection agreement

  • ● You will learn about clinical studies and participant rights

  • ● You will learn about ethical requirements and guidelines

  • ● You will learn how to include data protection in your clinical trial documents

During and after this course, you will receive

  • ● Documents and templates prepared specially for course participants and worth up to $5,000, including:

  • - Legitimate Interest Assessment template

  • - Data Protection Impact Assessment worksheet and template

  • - Records of Processing Activities

  • - Privacy Policy template

  • - Data Security checklist

  • - Breach exercise slides, training materials and many more

  • ● Training and material to support your in-house staff in acting as DPO, saving many thousands of dollars annually

  • ● 1-hour consultation with our data protection experts – a $300 value

  • ● A certificate of course completion

Course curriculum

Module 1: Introduction

  • Lesson 1: Why Are You Taking This Course?

  • Lesson 2: What Are the Elements of This Course?

  • Lesson 3: Introducing Data Protection and GDPR

  • Lesson 4: Beyond GDPR

Module 2: Our Data

  • Lesson 1: Introducing the 'Lawful Basis' Requirement

  • Lesson 2: The Legitimate Interest 'Lawful Basis'

  • Lesson 3: The Scientific Research 'Lawful Basis'

  • Lesson 4: The 'Lawful Basis' For Study Staff

  • Lesson 5: Data Minimization

  • Lesson 6: Genetic Data

  • Lesson 7: Pseudonymization and Anonymization

  • Lesson 8: Secondary Use of Clinical Study Data

Module 3: Our Organization

  • Lesson 1: Training

  • Lesson 2: Data Security

  • Lesson 3: Breach Response

  • Lesson 4: Access Management

Module 4: Our Services

  • Lesson 1: The DPIA

  • Lesson 2: Data Protection by Design

  • Lesson 3: Patient Centricity and Data Protection

Module 5: Our Partners

  • Lesson 1: Controllers and Processors

  • Lesson 2: The Data Protection Agreement

  • Lesson 3: The Data Protection Agreement Log

  • Lesson 4: International Transfer

Module 6: Our Data Subjects

  • Lesson 1: Clinical Study Participants

  • Lesson 2: Children and Vulnerable Groups

  • Lesson 3: Clinical Study Personnel

  • Lesson 4: Our Employees

  • Lesson 5: Transparency

  • Lesson 6: The Right to be Forgotten

  • Lesson 7: The Right to Access Data

Module 7: Our Vendors

  • Lesson 1: The Records of Processing

  • Lesson 2: Data Protection Officers

  • Lesson 3: Websites

  • Lesson 4: EU Representative

Module 8: Our Data Protection Authority

  • Lesson 1: Breach Reporting

  • Lesson 2: Registration

  • Lesson 3: Prior Consultation

  • Lesson 4: Ethical Requirements and Guidance

  • Lesson 5: Conclusion

Course price:

1,200$

COURSE CONVENOR

Arye Schreiber Arye is the CEO of MyEDPO, a data protection consultancy. Arye has a law degree from the University of Cambridge, an LLM from the University of London, and an MBA from Stanford University. He is a fellow of the International Association of Privacy Professionals, and he is a Certified Data Privacy Solutions Engineer from ISACA. His research has been published in leading journals such as Oxford's International Data Privacy Law journal, the Intellectual Property Quarterly, and the Cambridge Law journal. Arye and MyEDPO's experts have many years of real-world experience dealing with data protection across industries and sectors.