Major topics of the training:

The General Data Protection Regulation (GDPR) (EU) 2016/679 came into effect on May 25th, 2018 in all EU member states without any transitional period, replacing the EU Data Protection Directive 95/46/EC. How does GDPR affect clinical research? Clinical study data are considered a “special” data category whereby processing is necessary for scientific or research purposes.

This course is a comprehensive guide to the basic principles of GDPR and provides a practical understanding of the implications and legal requirements for organizations involved in clinical research. The course will start with an overview of the regulation, focusing on the key areas, concepts, principles, terms and definitions of GDPR. Furthermore the course will explain in more detail the impact of this regulation on the conduct of clinical studies. Finally, this will help you to make an overview of outstanding action items how to comply with the new regulation.

 

Content:

• What is GDPR?
• What are “Personal Data” and what means “Processing of Personal Data”?
• What is the Territorial Scope of the GDPR?
• What are the General Rules in GDPR and how do they affect Clinical Research?
• Which are the Involved Parties within Clinical Research in GDPR and what are their responsibilities?
• Is a Data Protection Officer (DPO) required?
• How to conduct a Data Protection Impact Assessment(DPIA)?
• How to notify a personal data breach?
• What is the impact on the contracting practices?
• Data Subject Rights in Clinical Research?
• What about Data Transfers in- and outside the EU?
• Privacy Checklist: How to be GDPR compliant?

 

Who should take the course?

Anyone working in clinical studies, including managers and quality assurance personnel, seeking to gain knowledge of the GDPR requirements applicable to clinical studies.

• Sponsors of Clinical Studies 
• Study site staff
• Clinical Research Organizations and other vendors working on clinical trials

There are no formal entry requirements. No prior training in or working experience with data privacy regulations is required.

 

Duration: 120 minutes

Price: 240 € (Excluding VAT chargeable in Belgium and EU)

 

Course dates (webinar):

Contact AML to request training dates.

Booking on to a course: 

If you want to register for this course, please send an email to training@aml-research.be and mention:

• Course title
• Course date
• Title, First Name, Last Name and email addresses of trainees
• Invoice details

Requests for registration should be send at least 3 days (72 hours) prior to the course date.

We will then provide you via email with a confirmation of registration and further information.