The GDPR (Regulation (EU) 2016/679) will have direct effect from May 25th, 2018 in all EU member states without any transitional period, replacing the EU Data Protection Directive.
The regulation emphasizes and standardizes transparency, security and the accountability of ‘Data Controllers’ with the aim to strengthen the rights of individuals.
Responsibilities and requirements of healthcare suppliers (including clinical researchers and companies) are clearly described.
This TRIUM session will start by offering you a high-level overview of the regulation, focusing on its definitions and requirements, immediately followed by explaining the impact on the conduct of clinical trials.
All your questions related to the data processes and protection principles in clinical trials, subject rights and consent and actions to be taken in case of a personal data breach will receive a clear and practical answer. It will enable you to conduct a data protection impact assessment for your organization’s current and future clinical trial needs, which will help you to set up an action plan to fill any data protection gaps by May 25th, 2018 and beyond.
Our aim is to ensure a lively, interactive, practical session with experts and peers that ensures you will be able to list your gaps and set-up your action plan for compliance immediately after.
At the end, you will receive a certificate and handy hand-outs for later use.
By the end of this TRIUM Training you should be able to:
- Describe the data protection requirements and obligations as per the GDPR (Regulation (EU) 2016/679)
- List the responsibilities and obligations of healthcare professionals and companies, including clinical researchers
- Conduct a data protection impact assessment and roll-out a related action plan for your organization to ensure timely compliance
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.