Part One: Aligning Regulatory Requirements From the Start

U.S. companies partnering with European laboratories or research sites are stepping into a regulatory environment that is more coordinated—and more demanding—than ever. In many cases, they are subject to two distinct EU frameworks: the General Data Protection Regulation (GDPR) which governs data protection, and the Clinical Trials Regulation (EU) 536/2014 (CTR), which governs clinical trials.

The risk isn’t just regulatory exposure. The GDPR and CTR operate on different legal foundations that can easily become misaligned in practice, leading to delayed trial approvals, disrupted data flows, and downstream issues in commercialization and regulatory filings.

Understanding how these frameworks interact can be essential not only for compliant and ethical clinical trial execution, but also for maintaining momentum. Companies that align these requirements early are more likely to operate with greater efficiency and avoid costly rework later.

This first article in our two-part series examines where GDPR and CTR requirements commonly diverge operationally and why those distinctions matter for sponsors conducting clinical trials in Europe.

Where Sponsors Typically Get This Wrong

Before diving into the frameworks, it is worth highlighting several recurring issues that commonly create operational and compliance challenges for sponsors:

• Treating CTR informed consent as GDPR consent for data processing
• Delaying lawful basis decisions until after protocol development
• Underestimating the coordination required for CTIS submissions
• Failing to align CROs, labs, and vendors on data protection requirements

Each of these issues creates friction that shows up later—in approvals, audits, or operational delays.

How GDPR Applies to Clinical Research

Clinical trials involve the large-scale collection and use of highly sensitive personal data, including health and genetic information. Under the GDPR, this data qualifies as “special categories of data,” triggering heightened protection obligations and more complex compliance considerations.

In practice, a few areas tend to create the most friction for sponsors:

1. Determining the Lawful Basis for Processing

Although consent is a requirement under both laws, GDPR also mandates that consent be “freely given,” a standard that is unlikely to be satisfied by CTR participant consent given the inherent imbalance of power between sponsors and subjects.

Sponsors subject to GDPR typically rely on other lawful bases for processing provided under GDPR:

• • • Public interest or legitimate interest (Article 6), and
    • Public health or scientific research (Article 9)

What this means in practice

Selecting the appropriate lawful basis under the GDPR can shape how the trial is structured and executed. These decisions usually need to be made early, often before protocol finalization, because they drive privacy disclosures, vendor arrangements, and cross-border data transfer mechanisms.

If addressed too late, sponsors may need to revisit and revise documentation across multiple jurisdictions—creating avoidable delays and added cost.

2. Transparency Requirements

Under GDPR, participants are required to receive clear privacy notices describing:

• • • Who is processing their data
    • What categories of data are collected
    • What are the purposes of processing and lawful bases
    • Will data be transferred outside the EU
    • How long will data be retained
    • What GDPR rights apply and where those rights may be limited

What this means in practice

Privacy disclosures often lag behind protocol development, which can result in notices that do not fully reflect how data is actually be collected, used, and shared in practice. Legal, clinical, and data teams usually need to coordinate early to ensure disclosures are accurate, complete, and aligned with operational realities.

This is particularly important where GDPR rights may be limited. For example, the right of erasure may not apply in situations where data must be retained for scientific research integrity or regulatory compliance. To avoid confusion and reduce downstream risk, privacy notices can clearly address these limitations.

3. Extraterritorial Reach: When GDPR Applies to Non-EU Sponsors

The GDPR applies whenever:

• • • Trial participants are located in the EU
    • EU sites or investigators establishment involved in the study
    • The trial sponsor monitors the behavior of individuals in the EU.

What this means in practice

If any part of a trial touches the EU, it is best to assume GDPR applies and scope compliance accordingly. Attempts to narrow applicability late in the process rarely hold up.

Non-EU sponsors are often required to appoint an EU representative.

Obligations under the Clinical Trials Regulation (CTR)

The CTR, fully applicable since 2022 when it replaced the former Clinical Trials Directive, harmonizes clinical trial approvals across the EU and introduces new coordination requirements.

1. Informed Consent

CTR informed consent is an ethical and procedural requirement, separate from GDPR consent. CTR requires that participants be fully informed about:

• • • the study’s purpose, risks, benefits
    • data use and confidentiality,
    • the right to withdraw.

Electronic informed consent is permitted, subject to national rules.

2. Centralized EU Trial Submission

The CTR introduced the Clinical Trials Information System (CTIS), enabling a single trial application for all EU Member States. The assessment is divided into:

• • • Part I: coordinated scientific evaluation
    • Part II: national and ethics committee review

The centralized process reduces fragmentation—but increases the need for internal alignment. Inconsistent submissions or delays in responses can slow approvals across multiple countries at once.

3. Transparency and Public Disclosure

The CTR requires

• • • public registration of trials
    • publication of lay summaries
    • clear and detailed documentation of safety monitoring, data handling, and subject protections

Because trial information is more visible than under the prior regime. sponsors may want to align legal, regulatory, and communications teams early to ensure consistency in messaging and disclosures.

Other Requirements

1. DPIAs and the Role of the DPO

Because clinical trials involve large-scale processing of sensitive data, most trigger the need to conduct a Data Protection Impact Assessment (DPIA). Also, a Data Protection Officer (DPO) is required whenever the organization’s core activities involve regular, systematic processing of such data—which is common in clinical research.

These are not just documentation exercises. DPIAs and DPO involvement are both core components of data governance involving decisions around risk mitigation, security measures, and data flows. Sponsors that treat this as a strategic step (rather than a compliance formality) are usually better positioned to avoid regulatory issues later.

2. National Laws

Although the CTR harmonized many aspects of clinical trial approval, certain elements remain subject to the national laws of individual EU Member States, including:

• • • Rules for minors or incapacitated adults
    • Compensation and insurance requirements
    • Rules governing the handling of human biological samples

To ensure compliance, sponsors may want to build local law validation into their trial launch process. Assumptions that hold in one Member State may not apply in another, and gaps here can delay approvals.

Conclusion

Conducting clinical trials in Europe usually requires more than parallel compliance with GDPR obligations and the ethical, procedural, and transparency requirements of the CTR. It also can necessitate coordination across legal, clinical, and operational teams from the outset.

By aligning on lawful basis for data processing, data governance, and submission strategy early, U.S. sponsors can operate more efficiently, reduce rework, and maintain flexibility as trials evolve. Those that don’t often find themselves revisiting foundational decisions at the worst possible time—midstream, when timelines and costs are already under pressure.

In Part 2 of this series, we examine the practical compliance expectations increasingly shaping clinical trials involving EU data, including lawful basis selection, CTIS coordination, DPIAs, cross-border transfer considerations, and operational readiness steps for sponsors and clinical teams.

For assistance updating your clinical trial templates or conducting a GDPR compliance review, please contact Stephan Grynwajc at stephan@outsidegc.com.

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Stephan Grynwajc is admitted to the practice of law in the U.S., Canada, U.K. and in France/the European Union. He has served as a senior in-house attorney for several blue-chip technology corporations (e.g., Intel and Symantec) in France, the U.K. and the U.S., and today, focuses his practice on advising U.S.-based clients on navigating the EU, UK and Canadian legal and regulatory landscape.