Description
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, …
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.
Course time
09h00 - 17h00Who should attend
- Anyone working in Clinical Research who wishes to understand the Data Protection Laws and their implementation.
- Higher management of a CRO / the pharma industry
- Members of the Quality Assurance department
- Members of the Quality Control department
This course is intended for people with no legal background.
Programme highlights
1st part of the day:
- Belgian and European data protection rules: definitions
- The applicable obligations when processing and transferring personal data
- How to apply the data protection rules in practice
2nd part of the day:
- Impact (and action plan) on clinical trials and your organisation
- Impact on vendor management
- Is a DPO required or not and what should this person do?
Learning Objectives
1st part of the day:
- Be able to identify the important data protection issues when organising clinical trials
- Become confident with the applicable Belgian and European data protection regulations
- Learn how to apply the data protection rules in practice
2nd part of the day:
- Explain the reach of this regulation on the various departments of a CRO
- Learn the reach of this regulation on the Principal Investigator
- Be able to set up an action plan to be GDPR compliant
- Organise a register process to report a breach
- Deploy a Data Protection Impact Assessment (DPIA)
Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design (0)
- Ethical & Participants Safety Considerations (2)
- Investigational Product Development and Regulation (1)
- Clinical Studies Operations (GCPs or ISO 14155) (0)
- Study and Site Management (2)
- Data Management and Informatics (1)
- Leadership and Professionalism (1)
- Communication (0)
- Teamwork (0)
- Business acumen (0)
Be aware that attending one of ECCRT open course does not guarantee that the competency is acquired but only guarantees that the related knowledge has been trained