As with all aspects of GDPR compliance, any system, process or infrastructure that uses personal data must be created and designed from the beginning by identifying possible risks to the rights and freedoms of the data subjects and minimising them before they can cause actual damage – privacy by design. GDPR data requirements on closing a clinical trial are no exception.
Clinical Trial GDPR Compliance: Key GDPR considerations often overlooked by non-EEA clinical trial sponsors
When learning anything new, something will inevitably be forgotten or overlooked. And implementing the GDPR for the first time is no exception, especially when we can only draw upon other data protection and data privacy laws with very different compliance requirements. This is where a GDPR compliance consultancy can keep you on track, ensuring nothing slips through the net.
Data protection concerns: Will the UK’s new data protection bill upset the EU-UK adequacy agreement?
In June 2021, the European Commission (EC) granted an ‘adequacy’ decision to the UK – effectively agreeing that UK legislation at the time, the UK GDPR, alongside an amended version of the Data Protection Act 2018 (DPA 2018), offered an equivalent level of data protection to EU citizens in a similar way to the EU GDPR.
No EU-US adequacy decision – what next for personal data transfers between the EEA and the United States?
Based on the current EU-US Data Privacy Framework, MEPs voted against greenlighting an adequacy decision for personal data transfers between the EU and the US. But as frustrating as that may be for US companies, what’s important is that US pharmaceutical research organisations focus on conducting Transfer Impact Assessments (TIAs) and use GDPR compliance frameworks, such as Standard Contractual Clauses, until the next steps become clearer within the EEA.
This article discusses what the regulations say about data protection and privacy training, who should receive training and the benefits to your organisation of raising awareness among your staff.