Explicit consent is often used as legal basis for the processing of any trial related personal data. However, if local legislation does not mandate this, other options are available. Based on the ‘European Data Protection Board Opinion 3/2019’ recommendations, this 30’session explains which legal basis can and cannot be selected for the processing of (sensitive) personal data for clinical trial purposes. Because of the direct link between legal basis and data subject rights, it is important to choose it wisely for both subject protection, compliance and research purposes.
By the end of this TRIUM Training you should be able to:
- Explain different interpretations of GDPR in the EEA member states are possible
- Explain the different legal basis for the collection of special categories of personal data
- List updates and lessons learned since the launch of GDPR on May 25, 2018
Can perform the task and/or exhibit the knowledge at an essential or foundational level. May require some coaching or supervision.