May 15th, 2025
In an era of increasing digitalization in healthcare and clinical research, the risk of personal data exposure has become a central concern for sponsors, CROs, and sites alike. A data breach — defined under the EU’s General Data Protection Regulation (GDPR) as a breach of security leading to the accidental or unlawful destruction, loss, alteration, unauthorized disclosure of, or access to personal data — is not only a regulatory issue but a reputational and operational one. And while this concept is widely recognized within the EU, similar definitions and obligations exist in Switzerland (FADP), Brazil (LGPD), and other data protection regimes worldwide.
To comply with these regulations, companies are expected to establish standard operating procedures (SOPs) for managing data breaches. These SOPs form a crucial part of implementing data protection by design and by default, ensuring that both technical and organizational safeguards are embedded into clinical operations from the outset.
But here’s the key question: once a data breach SOP is in place and the team has received general data protection training, what more is needed? Why invest in targeted data breach awareness training?
The answer lies in the complexity and subtlety of what constitutes a data breach — especially in clinical trials.
Not All Breaches Are Obvious
It’s easy to recognize a cyberattack that compromises a clinical trial database as a data breach. But data breaches take many forms, and not all are catastrophic. In fact, many incidents are small, even “innocent”-looking — but still qualify as data breaches under the law.
Examples include:
- A delegation log sent by email to the wrong site contact
- A printed informed consent form left behind in a meeting room
- A monitor accessing patient data on a shared screen during a Teams call
These events may not present a high risk to data subjects. They may not trigger mandatory notification to authorities or to trial participants. But they still require:
- Logging and documentation
- Risk assessment
- Potentially corrective or preventive actions
And most importantly, they often reveal vulnerabilities that need addressing before something more serious occurs.
From Procedure to Practice: The Value of Awareness
Training in data breach awareness bridges the gap between theory and real-world decision-making. SOPs are only effective if people recognize a breach when it happens — and feel confident knowing what to do next.
Dedicated awareness sessions offer an opportunity to:
- Revisit actual case studies from clinical operations
- Review common scenarios that lead to unintentional breaches
- Emphasize the distinction between “reportable” and “non-reportable” breaches
- Clarify roles and responsibilities, including what constitutes the “first 24 hours” post-incident
Moreover, these trainings foster a speak-up culture, empowering staff to report issues early without fear or hesitation.
Learning from the Past, Preventing the Future
Another key benefit of awareness training is the opportunity to proactively share lessons learned from previous breaches. By analyzing trends — repeated errors in document handling, recurrent confusion about pseudonymization, or improper access controls — teams can collectively implement preventive measures.
Awareness training isn’t only about risk mitigation. It’s about building organizational resilience. Just as we conduct fire drills to test our readiness in the event of an emergency, MyData-TRUST recommends running breach reporting dry-runs to test both the process and the people involved.
This is particularly important given that many breaches occur outside of standard hours — Friday evenings, weekends, and public holidays. In those moments, the first line of defense is awareness. A team that is well-trained and aware is more likely to react effectively and limit the impact.
A Proactive, Low-Cost, High-Value Investment
At its core, data breach awareness training is about reducing risk — for patients, sponsors, CROs, and sites. It is an investment that pays dividends:
- Fewer breaches
- Faster, better-coordinated responses when they do occur
- Fewer regulatory concerns and audits
- Stronger confidence from partners and regulators
MyData-TRUST recommends at least one awareness session per year, tailored to the organization’s risk profile and trial portfolio. Ideally, these should be:
- Interactive
- Scenario-based
- Supported by materials that are practical, not theoretical
Conclusion
In clinical trials, the stakes are high. Protecting data is protecting patients — and protecting your ability to operate effectively. SOPs and general training are critical starting points, but without regular, targeted data breach awareness, even the best policies can fail in practice.
In the end, awareness is preparedness — and preparedness is the best defense.
Need help tailoring your breach awareness strategy or running a dry-run? Ask your MyData-TRUST DPO — we’re here to support you.
