Top 3 GDPR Compliance Questions in Clinical Trials

In the fast-evolving world of clinical trials, GDPR compliance is more than a legal obligation—it’s a pillar of trust, data integrity, and organizational protection. Non-compliance not only risks fines but also jeopardizes participant trust and organizational credibility. As 2025 unfolds, here are the three key questions sponsors often ask about GDPR compliance and why addressing them is vital for success in the EU and beyond.

1. Why Do Sponsors Need to Prioritize Data Protection?

Even with an experienced CRO managing your trials, the ultimate responsibility for GDPR compliance lies with you, the sponsor. Under GDPR, sponsors are classified as data controllers, meaning regulators will hold you accountable for any breaches or non-compliance—not the CRO, which serves as a processor acting on your instructions.

This distinction is crucial because it places the legal burden squarely on the sponsor, regardless of the CRO’s expertise. For example, if a CRO mishandles participant data or suffers a breach, regulators will look to the sponsor to explain the oversight and ensure remedial action.

Compliance isn’t just about avoiding fines—it’s about safeguarding your reputation and ensuring trials proceed smoothly. Regulatory penalties for non-compliance can be severe, with fines reaching up to €20 million or 4% of global turnover. Moreover, breaches can result in trial delays, participant lawsuits, and long-term damage to credibility in a highly competitive industry. The loss of trust from participants, investigators, and stakeholders is often more detrimental than the immediate financial penalties.

Due diligence on CROs is essential. Sponsors must evaluate their data protection policies, audit compliance practices, and verify GDPR adherence in all processing activities. This includes assessing the technical and organizational security measures in place to protect sensitive health data throughout the trial lifecycle. Without these checks, sponsors risk exposing themselves to significant legal and reputational harm.

2. What Are the Key GDPR Obligations for Clinical Trials?

The cornerstone of GDPR compliance in clinical trials is respecting participants’ rights while balancing the scientific and operational needs of the study. Three key obligations often dominate the compliance landscape: transparency, data minimization, and data security.

• Transparency and Informed Consent

Participants must clearly understand how their personal data will be used, who will have access to it, and how long it will be retained. In the scope of clinical trials, consent to participate is a mandatory requirement under the Clinical Trial Regulation. So, without independence of relying on consent as a legal basis or using the Informed Consent Form as a privacy notice, information about the processing activities must be transparent and unambiguous.

• Data Minimization and Purpose Limitation

GDPR mandates that sponsors collect and process only the data necessary for achieving the trial’s objectives. This principle prevents over-collection and ensures ethical use of participants’ personal information. Sponsors should also clearly define the purposes of data collection and avoid repurposing data without a new legal basis. In order to do so, several GDPR assessments need to be performed, such as the Legal Basis Assessment (LBA), the Legitimate Interest Assessment (LIA) to ensure when processing relies on the legitimate interest of the Sponsor, the rights of the data subjects are not overridden by the legitimate interests pursued. In addition to this, a Record of Processing Activities (ROPA) must be performed, to demonstrate accountability and show the processing of personal data for the clinical trial is known and controlled.

• Data Security and Breach Notification

Protecting sensitive health data is paramount. Sponsors must implement robust technical and organizational safeguards to prevent unauthorized access, loss, or theft. In this regard, the processing of a Data Protection Impact Assessment (DPIA) for the clinical trial is required, to evaluate the risks of the processing and to implement adequate security measures to protect the data. This includes encryption, pseudonymization, and secure data storage systems. In the event of a data breach, sponsors are obligated to notify regulators within 72 hours and, in some cases, inform affected participants. Rapid response plans are essential to meet these tight deadlines and mitigate damage.

3. How Can Sponsors Ensure Long-Term Compliance?

GDPR compliance isn’t a one-time task—it requires a proactive, ongoing commitment. Sponsors can ensure sustained compliance by embedding data protection principles into every stage of the clinical trial process.

• Establish Comprehensive Policies and Procedures

Clear, detailed policies are the foundation of GDPR compliance. These should cover every aspect of data handling, from collection and storage to processing and sharing. Policies must also address cross-border data transfers, especially for trials involving international participants or global partnerships. A well-documented approach not only ensures consistency but also demonstrates accountability to regulators.

• Invest in Training and Awareness

Compliance depends on people as much as processes. Training all your staff and ensuring all stakeholders—including CROs, site staff, and even third-party vendors—receive training on GDPR requirements is essential. Regular training sessions help maintain awareness and reduce the likelihood of accidental breaches or missteps.

• Appoint a Data Protection Officer (DPO)

For trials involving significant data processing, appointing a DPO is mandatory, but even in circumstances when such appointment is not mandatory per law, organizations without proper data protection support should consider appointing one voluntarily, to ensure compliance. A DPO provides expert oversight, monitors compliance efforts, and serves as a liaison with regulators and participants. Their role is particularly critical for managing complex compliance scenarios, such as trials involving diverse jurisdictions or sensitive populations.

Conclusion: Compliance as a Strategic Advantage

In the EU, GDPR compliance is more than a regulatory requirement—it’s a strategic advantage. By prioritizing data protection, sponsors can safeguard participant trust, mitigate risks, and uphold the integrity of their trials. In a competitive landscape, demonstrating a strong commitment to privacy can attract participants, partners, and investors who value ethical and compliant research practices.

As we enter 2025, embracing GDPR compliance means more than avoiding penalties. It reflects a dedication to advancing science responsibly, protecting participant rights, and ensuring the success of your clinical trials. By embedding data protection into the fabric of your operations, you can confidently navigate the challenges of clinical research in the modern era.