The EU Clinical Trials Regulation (CTR), effective from January 31, 2022, has reshaped the clinical trial landscape across the European Union. First introduced in 2014, the regulation introduces significant changes aimed at streamlining clinical trial processes and ensuring consistency across EU member states. 

One of the most impactful updates is the introduction of the Clinical Trials Information System (CTIS), a centralized platform for clinical trial applications. On January 31, 2023, the CTIS became mandatory for all new submissions. By January 31, 2025, all ongoing trials must transition to the CTIS, marking a crucial shift toward unified regulatory processes.

These updates significantly affect multilingual compliance in clinical trials, reinforcing the need for accurate translation and localization of regulatory documents. Companies need to swiftly adapt to these requirements, ensuring that all patient-facing and regulatory materials are precise and culturally adapted for each local market.

Key Changes in the EU Clinical Trials Regulation

Centralized Application Portal

The CTIS enables sponsors to submit a single clinical trial application across multiple EU member states, replacing the need for country-specific submissions. This change significantly simplifies the submission process, reducing administrative burdens and enabling a more harmonized approach across borders. With the deadline for transitioning all ongoing trials to the CTIS set for January 2025, sponsors need to ensure they are ready for this unified system.

Increased Transparency and Reporting Requirements

The CTR strongly emphasizes transparency, mandating that all clinical trial data, including results and regulatory decisions, be made publicly available through the CTIS. This ensures that healthcare professionals, regulatory bodies, and the public have access to critical clinical findings, fostering trust in the trial process, preventing research duplication, and enhancing patient safety.

Enhanced Safety Monitoring Across the EU

Under the CTR, stricter safety monitoring protocols require real-time reporting of adverse events and safety signals via EudraVigilance, the EU’s system for monitoring suspected adverse drug reactions.

This real-time reporting enables faster regulatory responses to emerging safety concerns, helping to safeguard patients and maintain high safety standards across all EU member states by adhering to tight reporting deadlines. Accurate translations are critical to ensure that these reports are submitted on time.

Multilingual Documentation Requirements Under the CTR

For companies conducting clinical trials in Europe, multilingual compliance is a fundamental part of meeting the CTR’s requirements. Here’s what companies need to know about the documentation and translation requirements of the regulation:

• High-Quality Translations of Regulatory Documents: The CTR mandates that critical documents, such as study protocols, patient information leaflets (PILs), and informed consent forms (ICFs), be translated into the official languages of each participating country. This ensures the information is accurate, accessible, and compliant with local regulatory standards.
• Layperson Summaries: Clinical trial results must be presented in clear, easy-to-understand summaries, translated into the official languages of the participating countries. These summaries should be culturally adapted to ensure they are accessible to non-specialists, including patients and the general public.
• Timely Safety Report Translations: Due to the urgency and complexity of safety reports, they must be translated promptly and accurately to meet strict regulatory deadlines. These translations need to convey precise medical information to avoid any risk of misinterpretation.

How Welocalize Supports Multilingual Compliance Under the CTR

At Welocalize, we help life sciences companies meet the multilingual and regulatory demands of the EU Clinical Trials Regulation. Our services ensure that clinical trial translations are accurate, culturally adapted, and compliant with local regulations across all EU member states. Here’s how we support regulatory compliance:

• Multilingual Compliance Expertise. Our teams of translation and localization experts collaborate with regulatory specialists to deliver high-quality translations for clinical trial documents, ensuring compliance with local standards in each participating country. This includes essential documents such as study protocols, PILs, and ICFs.
• Transparent and Accessible Layperson Summaries. We simplify complex clinical trial results into layperson summaries, ensuring they are understandable across different languages and regions. Our approach leverages AI-powered tools alongside expert human review to ensure both cultural relevance and clarity.
• Culturally Adapted and Accurate Translations. We deliver culturally adapted translations ensuring that patient-facing materials are legally compliant and easily understood. Our process includes back-translation to verify accuracy and eliminate misinterpretations, ensuring the highest standards of quality and integrity. Back-translation ensures that the meaning of the original document is maintained across languages, minimizing risks of errors in regulatory and safety-related documents.
• Rapid Turnaround for Safety Reports. Time-sensitive documents, such as adverse event reports, require swift and precise translations. We use AI-powered workflows to ensure timely, high-quality translations that allow companies to meet critical regulatory deadlines while maintaining human oversight for compliance.
• Centralized Translation Management. To support centralized submissions through the CTIS, we ensure that translations are consistent and compliant across all EU member states. Our collaborative teams provide high-quality translations tailored to each country’s regulatory requirements.
• Continuous Training and Development. Our linguists and project managers receive ongoing training to stay up-to-date with the latest medical and regulatory terminology, ensuring precision in regulatory documents and pharmacovigilance.

Why High-Quality Translations Are Essential for CTR Compliance

Meeting the CTR’s multilingual requirements involves more than just literal translation. Companies must ensure that translated documents are both accurate and culturally adapted for each local market. This is vital for:

1. Ensuring Patient Safety: Accurate translations of safety reports and patient information help ensure that patients have access to clear, understandable information that protects their safety.
2. Meeting Regulatory Deadlines: Precise and timely translations are essential for meeting strict regulatory deadlines and avoiding delays in the trial approval process.
3. Fostering Trust Through Transparency: High-quality translations of clinical trial results and summaries help healthcare professionals, patients, and regulators understand and trust the information being shared.

Looking Ahead: Adapting to Ongoing Changes in the CTR

As the EU Clinical Trials Regulation continues to evolve, ensuring multilingual compliance remains essential for companies conducting clinical trials in Europe. At Welocalize, we are committed to helping life sciences companies navigate these ongoing changes. Our commitment to enhancing collaboration, optimizing workflows, and staying updated on regulatory updates positions us to meet future challenges head-on.

By taking the right approach to multilingual compliance, companies can ensure smoother regulatory processes, foster greater trust in clinical research, and contribute to the advancement of medical research across Europe.