European Regulation on personal data protection (EU/016/679)
- 5 feb
- 1 minuten om te lezen
The GDPR (General Data Protection Regulation) has been fully applicable across all EU Member States since May 25, 2018. As an EU regulation, it applies directly without requiring national implementation laws.
Its objective remains to strengthen the rights of individuals regarding data privacy and to ensure full transparency on how their personal data is collected, processed, and stored.
The GDPR clearly defines the obligations of any organisation handling the personal data of EU citizens. Your company falls under this regulation if:
you are an EU-based organisation conducting activities within the EU, or
you are a non-EU organisation that collects or processes personal data from EU citizens (for example: patient data, CVs from European vendors, investigator information included in your TMF, etc.).
Below you will find a link to a PDF slide deck prepared by Ad Hoc Clinical, summarising the key GDPR requirements and their implications for the conduct of clinical trials.
ECCRT offers an online, instructor-led course on implementing GDPR within your organisation, delivered by Nancy Cottigny.
