Reasons to attend

The purpose of this course is to explain how and under what conditions you can gather, collect, process, transfer (inside or outside the European Union), anonymise or encode and delete personal data as part of clinical trials. Moreover, it will help you to put in practice the GDPR in a CRO/pharmaceutical industry. This training will allow you to make an action list of what is needed for your organization to be GDPR compliant. We will analyse the impact of the GDPR on different departments including clinical operations, vendor management, HR, …

What's included?

• Documents and materials related to this course are included
• Globally recognised certificates awarded after test completion
• This course has been granted PharmaTrain Recognition

Course schedule

• One Day face-to-face training: 09h00-17h00

Course Description

The organisation of clinical trials might also include important data protection issues. It is important to know under what conditions the personal data of the patients participating in clinical trials (and of the investigators) can be processed in accordance with the applicable European and Belgian data protection rules.

The purpose of the first part of the course is to explain how and under what conditions you can gather, collect, process, transfer (inside or outside the European Union), anonymise or encode and delete personal data as part of clinical trials.

During the second part of the day, we will look at:

• GDPR in practice in clinical research
• Responsibilities of the:
  • CRO
  • Sponsor
  • Hospital
• Impact on your internal SOPs
• Action plan for various departments
  • Contract management
  • Clinical operations
  • Quality
• Reporting procedures in case of breach

After the course, you will be able test your comprehension with a final grading assessment.