3/02/2021
When the Brexit transition period ended at the end of 2020, the United Kingdom (UK) officially left the European Union (EU) single market and customs union. This means that for the purposes of the General Data Protection Regulation (Regulation (EU) 2016/679 or GDPR), the UK is a third country with regards to data transfer. As a third country, personal data transfers require additional safeguards. At the beginning of 2021, the EU-UK Trade and Cooperation Agreement came into effect. A part of this Agreement includes a provision which allows data transfers to continue without additional mechanisms until an adequacy decision is adopted, for a maximum of six months. An adequacy decision allows data transfers to occur without additional safeguards that are required for third countries. If no adequacy decision is made by June 30, 2021, the UK is considered a third country for personal data transfers from the EU including clinical trial data.
The European Commission (Commission) published a draft UK GDPR Adequacy Decision, which is the first step in the process. Next, the Commission seeks an opinion from the European Data Protection Board (EDPB), and then needs a green light from a committee of representatives of the EU Member States. The adequacy decision can be adopted at this point and would be effective for four years initially.
Why is GDPR Relevant to Clinical Research Professionals in the US?
Clinical trials are increasingly global by nature. The GDPR may apply to your clinical trial if conducted in a country within the European Economic Area (EEA) or the United Kingdom (UK) with their own UK GDPR. The GDPR data protections are broad in nature but it makes it clear that protection of personal data includes data created during the course of a clinical trial. Understanding the role your organization plays, which data are personal, and what constitutes a valid consent under GDPR requirements is key to compliance. The adequacy decision is important if clinical trial data needs to flow from the EU to the UK for your study.
Not sure if you need to worry about your study meeting requirements of the GDPR? Clinical Pathways offers an eLearning course on the GDPR and Clinical Trials for purchase in the online store HERE.
Customization Available
A customized curriculum can be developed for clinical research stakeholders such as sponsors Our courses are also offered as webinars or online workshops. Full LMS compatibility with SCORM packages available. Contact us at info@clinicalpathwaysresearch.com for additional information or to arrange a meeting to discuss.
Enterprise Pricing Available
Off the shelf pricing for over 10 licenses from the store is available when you contact us at info@clinicalpathwaysresearch.com.
Want training for longer than the license timeframe but do not have an LMS? Clinical Pathways can host annual training in our LMS to support your learners, with reports and certificates of completion for audit readiness.
- The Clinical Pathways Team
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