Clinical Trial Documentation: What Pharma Companies Need Translated

Running a clinical trial in the Czech Republic and trying to work out which documents actually need translating, and to what standard? The answer isn’t uniform across the trial package — some documents can stay in English, others must be in Czech, and at least one has an explicit certified-translation requirement from the regulator itself. This guide walks through the language rules, when certification matters, and how translation fits into the tight regulatory timeline.

Note: this article covers translation requirements as they relate to documentation, not regulatory or clinical guidance. For the full requirements of your specific trial, consult SÚKL or your regulatory affairs team.

• The scientific part of a trial application (protocol, investigator’s brochure) can generally stay in English.
• The national part — informed consent, patient information, labels, protocol synopsis — must be in Czech.
• SÚKL guidance requires a certified translation of informed consent when foreign participants are enrolled.
• Many ethics committees also require back-translation of consent documents, adding a separate step to the timeline.

This split trips up sponsors more than almost anything else in the documentation package, so it’s worth getting straight early.

The scientific part of the application — the protocol and investigator’s brochure — can generally remain in English, since this is the material reviewed at a technical level. The national part, by contrast, covers everything a trial participant or Czech authority interacts with directly, and this must be in Czech. This is submitted through CTIS, the EU-wide Clinical Trial Information System established under Regulation (EU) No. 536/2014.

This is the one place where the language requirement comes with an explicit certification standard, not just a translation requirement.

SÚKL’s own guideline (KLH-CTIS-01) is specific on this point: where foreign participants are included in a trial, and the informed consent or patient information sheet must be provided in a language the participant demonstrably understands, a certified translation of the Czech version of the document is required. This is submitted through CTIS as a non-substantial amendment. In practice, this means informed consent for foreign-language participants isn’t just translated for readability — it needs the formal certification that a Czech authority will accept as an accurate match to the approved Czech text.

Beyond the initial translation, many ethics committees expect an additional layer of verification specifically for consent documents.

Ethics committees and institutional review boards frequently require a full package for consent forms: the original document, the translation, and a back-translation — an independent translation of the Czech version back into the source language, done by a different translator than the one who produced the original translation. This isn’t a proofreading step; it’s a separate, independent check that the translated meaning matches the original, and it adds its own timeline to the documentation process rather than running in parallel with the first translation.

Translation delays matter more here than in most contexts, because the regulatory clock doesn’t pause to wait for them.

Once an application is uploaded to CTIS, a 10-day validation period checks for completeness, followed by a standard 45-day assessment period. If SÚKL raises a request for information (RFI), sponsors typically have only around 12 days to respond — and missing that window can cause the application to lapse automatically. Translation, particularly for informed consent and any documents affected by an RFI, needs to be ready well before these windows close, not scheduled as an afterthought once a deficiency letter arrives.

For sponsors and CROs running trials on an ongoing basis, a structured working relationship tends to work better than ordering translations trial by trial.

We typically set up a framework agreement covering all future trial documentation, with an NDA signed before any documents change hands and a trial-specific glossary to keep terminology consistent across protocol synopses, consent forms, and any back-translation work. Standard payment terms run on a 14-day basis, and express turnaround is available when RFI deadlines are tight.

We handle certified translation, back-translation coordination, and trial-specific glossaries under a single framework agreement.