Data Protection Strategies for Phase III Clinical Trials

Beyond the Science: Ensuring Privacy and Compliance in Phase 3 Studies

Phase III clinical trials are the pivotal bridge between early research and market approval, involving large, multi-site cohorts and intensive data collection. Because these studies handle sensitive health data at scale, they must comply with stringent privacy regulations, robust informed-consent protocols, and rigorous ethics-committee oversight. This article, illustrated with concrete case studies, outlines practical strategies for navigating privacy constraints: from required declarations and authorisations to complex cross-border data-transfer rules, overlapping jurisdictional requirements, and local formalities. Our goal is to give sponsors a clear roadmap for safeguarding participant data while keeping global trials on-schedule and inspection-ready.

The Funnel Strategy: Your Path to Regulatory Peace of Mind

The complexity of ensuring data protection compliance in clinical trials lies in the multiple, overlapping layers of regulation - ****ranging from general data protection laws to sector-specific guidelines. This challenge is amplified when trials are conducted across multiple countries or regions, each with its own set of rules and evolving requirements. As a result, it becomes difficult for sponsors to anticipate all obligations and stay updated with local nuances.

While there’s no one-size-fits-all solution, one effective approach we have found is what we call the funnel strategy. It begins by focusing on the most stringent regulatory framework, typically the GDPR, and identifying its core principles. Internal documentation and processes are then built around those principles. From there, country-specific requirements are layered in, adapting documentation and procedures accordingly.

From a data protection perspective, this means starting with the 10 core principles of the GDPR, setting up measures to comply with them, and clearly documenting those measures. Then, for each country involved, local adaptations are outlined and integrated into both internal records and key trial documents such as informed consent forms (ICFs), protocols, and risk assessments.

The funnel strategy helps sponsors maintain a globally consistent compliance framework, while also addressing local regulatory expectations in a structured and scalable way.

ICF and Appropriate Language: Balancing Local Regulations with Standards from Health Authorities

The Informed Consent Form (ICF) is a cornerstone of ethical human subjects research. The ICF must be comprehensible and accessible, considering the participant's language proficiency and local cultural nuances. Moreover, it should align with both local regulations and overarching standards set by regulatory authorities like the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) and ICH GCP framework..

Ethics committees play an indispensable role in this preliminary phase. They review the proposed study to ascertain its compliance with ethical standards, focusing on the safeguarding of participant welfare and data protection protocols. Engaging with these committees early in the planning stages can preempt potential hurdles and streamline the approval process.‍

Prior Declarations and Authorizations

Before commencing a phase 3 clinical study, several declarations and authorizations may be necessary depending in which country the clinical sites are being opened. Regulatory authorities often demand comprehensive documentation detailing the study's objectives, methodologies, and ethical considerations. These preliminaries are crucial for assessing the trial's feasibility and ensuring that it aligns with existing legal frameworks.

Focus : the example of France MR001 and Serbia

In France, for example, a specific authorization or declaration must be submitted to the CNIL by the clinical sponsor under the applicable framework, such as the Méthodologie de Référence (MR-001) for interventional studies.

DPO Decisions: When Skipping One Isn’t an Option

A Data Protection Officer (DPO) is indispensable in overseeing the compliance aspects of personal data processing within clinical trials. Especially under GDPR, appointing a DPO is often mandatory for organizations handling sensitive health data ( this i the case in France and Germany for exemple and recommended in the other 25 countries of the EU) The DPO's responsibilities include monitoring adherence to data protection policies, responding to data breaches, and acting as a point of contact between the organization and supervisory authorities.

Focus : the example of Germany and France

Under both French and German law, sponsors of Phase III clinical trials must appoint a Data Protection Officer (DPO). In France, the CNIL confirms that any recherche impliquant la personne humaine (MR-001) involves large-scale processing of health data, automatically triggering the GDPR’s Article 37(1)(c) obligation to designate a DPO. In Germany, the same GDPR rule applies, and § 38 BDSG adds a national duty whenever the controller conducts a DPIA—standard for clinical trials—or employs ten or more staff processing personal data. Failing to appoint a qualified DPO risks administrative fines and jeopardises study approvals. Sponsors should therefore secure DPO coverage (internal or external) before first-patient-first-visit in every participating EU state.

Is a Local DataProtection Representative Mandatory? What You Need to Know

A local data protection representative serves as an vital intermediary when conducting clinical trials in foreign jurisdictions. This role becomes particularly crucial in regions requiring the presence of a local contact for data protection purposes. Local data protection representatives facilitate communication between the sponsor and local supervisory data protection regulatory authorities, ensuring that all stipulations are met, and addressing any compliance issues that arise during the study.

Local data protection representatives can also provide valuable insights into regional data protection regulatory landscapes, helping sponsors adapt their strategies and documentation accordingly. For example, in some countries, having a local data protection representative is mandatory for filing applications with ethics committees or obtaining data protection clearances of the applications submitted to the ethics committees. By leveraging their localized knowledge, sponsors can efficiently navigate bureaucratic procedures and mitigate risks associated with non-compliance.

Focus: The Example of Georgia

For example, in Georgia, the "Law of Georgia on Personal Data Protection" mandates for the designation of a special representative in Georgia whenever the Sponsor, acting as the data controller and conducting activities falling under the scope of the Georgian data protection law, is using the "technical means available in Georgia". Whether or not this requirement applies to a specific clinical trial, requires ad hoc examination of the factual elements of the data processing and the technical means used. For example, from the interpretation of this term in practice it has been established that the mere use of a software available in Georgia, without its connection to a technical equipment ("server") is not in itself sufficient for the application of this requirement.

Focus: The Example of Serbia

On the contrary, in Serbia the situation seems more straightforward, with the "Law on Personal Data Protection" requiring the appointment of a Data Protection Representative and the registration of the data controller (here: the Sponsor) in the supervisory Data Protection Authority in Serbia ("Commissioner for Information of Public Importance and Personal Data Protection"), whenever the data processing falls under the scope of this local law.

Key Responsibilities of a Local Representative

While the exact duties of a local representative may vary based on jurisdiction-specific requirements, their primary responsibilities generally include:

• Acting as the main contact point for local data protection supervisory authorities regulatory authorities and/or ethics committees.
• Ensuring that the clinical trial adheres to local data protection laws and guidelines.
• Assisting in preparing and submitting necessary documents for approvals and authorizations.
• Providing guidance on regional healthcare standards and ethical norms.

Employing a competent local data protection representative can significantly bolster the smooth execution of international clinical trials. They help in bridging cultural and regulatory gaps, ensuring that the study upholds the highest standards of safety and integrity throughout its duration.

Challenges and Solutions

One common challenge in recruiting a local data protection representative lies in verifying their expertise and reliability. Given the complex nature of clinical trials and stringent regulatory scrutiny, sponsors must diligently assess the qualifications and track record of potential representatives. References from previous collaborations and certifications from relevant professional bodies can serve as reliable indicators of competence.

An effective solution is to establish long-term partnerships with accredited institutions or organizations that specialize in providing local data protection representation services. Such partnerships offer continuity and consistency, enabling sponsors to focus more on the scientific and operational aspects of the clinical trial rather than administrative hurdles. Additionally, continuous training and updates for local representatives ensure they stay abreast of evolving regulations and best practices.

Local Formalities Imposed on Sponsors as Data Controllers

While not all jurisdictions require the appointment of a local data protection representative, many still impose additional formal obligations on the Sponsor, who is typically considered the data controller in the context of a clinical trial. These obligations may include, for example, registration in data controller or DPO registers, or notifications to the supervisory authority prior to initiating processing activities involving "sensitive data".

Focus: The Example of the UK

In the UK, the data protection framework requires data controllers to register with the Information Commissioner's Office (ICO) and pay an annual fee. The amount of this fee is tied according to the controller's size (: number of employees) or annual revenue.

Focus: The Example of Ukraine

In Ukraine, data protection formalities are also notable. Under the Law of Ukraine on Protection of Personal Data, Sponsors must submit a declaration to the Commissioner for Human Rights of the Verkhovan Rada of Ukraine if their processing involves sensitive personal data, such as health information or data revealing racial or ethic origin of clinical trial participants.

International Data Transfers

What often proves more complex in practice is meeting the requirements of data protection laws in various jurisdictions when transferring personal data—processed in the context of a clinical trial, outside the territories where the trial sites are located, particularly to the Sponsor or its vendors.

In this regard, the European Union imposes well-defined legal conditions for such transfers through the comprehensive provisions of Chapter V of the GDPR. However, other jurisdictions may enforce even stricter rules, such as requiring prior approval from the local data protection authority or obtaining explicit consent from each data subject.

Focus: The Example of China

China’s international data transfer regime has been analysed in detail in iliomad’s previous article: [insert title and link here]. Its layered regulatory framework reflects a rigorous approach to cross-border data movement.

Focus: The Example of Georgia

In Georgia, any data transfer contract between the exporting entity (e.g., the clinical trial site) and the importing party (e.g., the Sponsor located in the U.S.) must receive prior approval from the national data protection authority. Alternatively, the explicit consent of each data subject (i.e., the study participant)must be obtained to legitimise the transfer.

Focus: The Example of Saudi Arabia

Influenced by the EU’s regulatory model, the Kingdom of Saudi Arabia has introduced a set of Standard Contractual Clauses (SCCs) that can be used without modification between data exporters and importers, thereby facilitating international data exchange in a structured and compliant manner.

Complying with cross-border transfer requirements is essential in the context of international clinical trials, where key actors, including Sponsors, CROs, and trial sites, operate across multiple legal and geographic landscapes.

Standardised Templates and their Significance‍

Finally, regulatory authorities in several jurisdictions have adopted templates that are either mandatory for use in the context of clinical trials, or recommended as appropriate language at the level of both the ICFs and CTAs.

Focus: The Example of Australia

Australia has implemented a national CTA template that must be used by Sponsors when entering into agreements with clinical trial sites. This template also addresses the privacy obligations inherent in such collaborations, thereby streamlining compliance expectations from the outset.

Focus: The Example of UK

Similarly, the UK mandates the use of standard templates for both the CTA and the data protection clauses of the ICF. Any deviation from these templates must be justified to the ethics committee and/or receive approval from the clinical trial regulatory authority.

Close monitoring of these national documentation requirements is essential, not only to prevent the unnecessary creation of additional regulatory burdens, but also to reduce delays during contractual negotiations and ethical committee review, including of those aspects related to data protection in the conduct of clinical trials.

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