Translating Clinical Trials and Regulatory Files

The translation of clinical trials and regulatory dossiers is a high-risk exercise for sponsors, biotech firms and CROs. Accurate medical terminology, rigorous traceability and compliance with the authorities' language requirements all determine whether a dossier is accepted. This B2B guide reviews the documents involved, the regulatory framework and good practice.

📖 Also read: pharmaceutical translation · technical translation · sworn translation guide

Which documents are involved?

A clinical trial generates a dense body of documents, much of which must be translated. These notably include:

• Protocols: the master document describing the objectives, methodology and criteria of the study.
• Informed consent forms (ICF): given to the patient, they must be drafted in their language.
• Investigator brochures (IB): a summary of preclinical and clinical data for the investigators.
• Case report forms (CRF): the structured collection of patient data.
• Patient information leaflets and SmPC: summary of product characteristics and patient information.
• Labelling: the packaging of investigational medicinal products.
• Correspondence with the authorities: exchanges with agencies and ethics committees.

The European and Belgian regulatory framework

At European level, the EMA (European Medicines Agency) coordinates the assessment, while the EU Clinical Trials Regulation (CTR, Regulation No 536/2014) harmonises the procedures. Submissions go through the CTIS portal, which centralises authorisation applications and imposes precise language requirements depending on the countries concerned.

In Belgium, the competent authority is the FAMHP / AFMPS / FAGG (Federal Agency for Medicines and Health Products). Documents intended for participants, in particular informed consent forms, must be available in the patient's language, namely French or Dutch depending on the region, and German where applicable. Ethics committees expect linguistically adapted and faithful versions.

Quality and traceability challenges

Terminological accuracy is central: an error in a dosage, an inclusion criterion or an adverse event can compromise participant safety and data validity. Translation relies on validated glossaries, translation memories and review by a second linguist. For informed consent forms, a back-translation (an independent translation back into the source language) is sometimes requested in order to verify compliance with the source text.

Process traceability is essential in an audited environment. Each version, each review and each validation is documented, in line with the quality expected of a pharmaceutical translation and, more broadly, of a rigorous technical translation.

Confidentiality and data protection

Clinical trial dossiers contain sensitive health data and strategic industrial property. The provider must guarantee a GDPR-compliant framework, non-disclosure agreements (NDAs), secure hosting in Europe and access restricted to the necessary contributors only. Where it applies, the pseudonymisation of patient data must be preserved through translation.

Tips for a compliant dossier

• Anticipate the language requirements per country from the design of the CTIS dossier.
• Provide a glossary and reference documents to the provider in advance.
• Allow the necessary time for the review and back-translation of ICFs.
• Lock down confidentiality with an NDA before any file transfer.
• Keep a complete audit trail of versions and validations.