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The EU's General Data Protection Regulation (GDPR) is the result of four years of work by the EU to bring data protection legislation into line with new, previously unforeseen ways that data is now used. It introduces tougher fines for non-compliance and breaches, and gives people more say over what companies can do with their data. It also makes data protection rules more or less identical throughout the EU.

Under GDPR, clinical trials involve processing sensitive personal data (Article 9) from EU/EEA citizens, requiring strict compliance by sponsors and researchers. Key definitions include: data subjects (participants), controllers (sponsors determining purposes), and processors (CROs/investigators). Key-coded data is still considered personal data. 

Key GDPR Concepts in Clinical Trials

• Definition of Personal Data: Any information relating to an identified or identifiable natural person, including medical records, genetic information, and identification numbers.
• Special Category Data: Health, genetic, and biometric data, which requires stricter processing conditions (Article 9).
• Data Controller: Typically the trial sponsor, who defines the purpose and means of data processing.
• Data Processor: Any entity (e.g., CROs, clinical sites) processing data on behalf of the controller.
• Lawful Basis for Processing: While consent is crucial for trial participation (Clinical Trials Regulation), GDPR requires a separate legal basis (e.g., public interest, legal obligation, or explicit consent) to process personal data.
• Key-Coded/Pseudonymized Data: Even if direct identifiers (like names) are replaced by codes, data is considered personal data under GDPR if the sponsor holds the key. 

Key Requirements

• Data Protection Officer (DPO): Required for organizations processing large-scale sensitive health data.
• Data Protection Impact Assessment (DPIA): Necessary for high-risk processing, which includes most clinical trials.
• Rights of Data Subjects: Participants have rights to access, erase, restrict, and transfer their data.
• International Data Transfers: Strict rules apply when transferring data outside the EU/EEA. 

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