On January 31, 2023 the EU Clinical Trial Regulation and the Clinical Trial Information System went live and changed the European landscape for clinical trials.
The EU Clinical Trial Regulation (CTR) and Clinical Trial Information System (CTIS) are simplifying the process of clinical trials in the EU while improving transparency and protecting participants. The regulation must be applied to all clinical trials conducted in the EU, regardless of whether the sponsor or the trial participants are based in the EU. When it comes to translations, the EU CTR has a significant impact on the requirements for clinical trials conducted in the EU.
The CTR states that all documents related to a clinical trial must be translated into the language(s) of the trial participants. This means that sponsors of clinical trials in the EU must make sure that all relevant documents are translated into the languages spoken by the trial participants. Moreover, the EU CTR requires that all documents submitted to regulatory authorities in the EU must be translated into the official language(s) of the member state where the trial is being held.
It's important to note that translations must be done by professional translators and reviewed by someone with a good understanding of the scientific content. This ensures that translations are accurate and consistent with the original documents. The CTR also requires sponsors to keep records of all translations, including the name of the translator, the date of the translation, and any changes made during the translation process.
While the EU CTR's translation requirements can be seen as an added burden to the already complex process of conducting a clinical trial, it ensures that patient-facing materials are easily understood by the trial participants and that the scientific content is accurately translated for regulatory authorities.
Using a language service provider (LSP) for EU CTR translation can provide several benefits:
- Expertise in medical and scientific translation
LSPs typically have teams of professional translators with specialized knowledge in medical and scientific terminology, which is essential for accurately translating clinical trial documents.
- Quality assurance
LSPs typically have quality assurance processes in place to ensure the accuracy and consistency of translations. This can provide peace of mind that the translations meet regulatory requirements and protect the integrity of the trial.
LSPs can handle the translation process efficiently and quickly, allowing sponsors to focus on other aspects of the trial.
- Compliance with regulations
LSPs are familiar with the CTR and other regulations related to clinical trials and can ensure that translations comply with these regulations.
- Language support
LSPs can provide translations in multiple languages, which is essential for clinical trials conducted in the EU, where trial participants may speak different languages.
LSPs can provide translation services at a lower cost than in-house translation teams, especially for multiple languages, and can also help with regulatory document formatting and submission.
In summary, using a language service provider for EU CTR translation can provide expertise, quality assurance, time-saving, compliance with regulations, language support, and cost-effectiveness.
Consider these factors to ensure readiness for compliance with the EU CTR:
- Protocol compliance: Ensure that the clinical trial protocol follows the CTR's guidelines for trial design, conduct, and reporting.
- Informed consent: Confirm that patient-facing materials, including informed consent forms, are translated into languages used by trial participants.
- Regulatory documentation: Ensure that all relevant study documents, such as the clinical trial protocol and investigator's brochure, are translated into official languages of the member state and comply with CTR requirements.
- Ethics approval: Verify that an ethics committee has approved the trial according to CTR requirements.
- Adverse event reporting: Check that the adverse event reporting system complies with CTR requirements, including timely reporting of serious adverse events to regulatory authorities.
- Quality assurance: Establish a robust quality assurance process to ensure translation accuracy and consistency, and keep records of all translations and any changes made.
- Transparency: Comply with the CTR's transparency requirements, including creating a trial master file and submitting information to the EudraCT database.
- Investigator's brochure: Ensure that the Investigator's brochure contains all the necessary information required by the CTR and is up-to-date.
- Data protection: Confirm that the trial process complies with EU data protection regulations, including GDPR.
- Cybersecurity: Establish adequate cybersecurity measures to protect trial-generated data.
Our in-depth whitepaper on EU CTR offers strategic considerations for sponsors as well as insights on the clinical trial submission process.