In clinical trials, any slip in interpretation can have serious consequences. A recent study in Datacubed Health states that errors in the translation of ePRO/eCOA reports can distort the validity of clinical data, which shows how much translation errors matter in clinical studies and how they affect the quality of a trial. This does not only affect scientific results: it can put patient safety at risk.

Research in hospital settings shows that using automated tools such as Google Translate produces failures in 32% of sentences that are critical to medical safety, including ambiguities in abbreviations and symptoms. These translation errors underline that delegating the work without specialist linguistic oversight can have significant clinical repercussions.

A report by Smartling also stresses that in global trials the confusion caused by incorrect translations of protocols and informed consent can reduce the quality of patient care and compromise the study’s results. These examples highlight the critical need to guarantee accuracy in every piece of translated content within a clinical trial.

The most frequent types of error

• Misreading abbreviations

Abbreviations such as QD (once a day), TID (three times a day) or BID (twice a day) can be misread if they are not correctly contextualised in each language. These errors usually stem from the translator’s unfamiliarity with medical terminology.

• Literal translation with no cultural adaptation

A literal translation of “informed consent” may not reflect its true legal or ethical weight in another country. The lack of cultural localisation in documents of this kind is one of the most frequent errors in clinical trial translation.

• Inconsistent terminology

Using different terms for the same concept (patient versus study subject, for example) creates confusion. Validated glossaries are fundamental to avoiding such errors.

• Omission of critical information

Details such as safety warnings, storage conditions or side effects can be overlooked. That affects not only the validity of the trial but can also put lives at risk.

• Lack of specialist review

Many CROs skip the medical or legal review that should follow translation. As a result many errors that a simple review would have caught remain in place and damage both the company’s reputation and the scientific community.

Examples of mistranslated abbreviations and terminological inconsistencies

All of these abbreviations are taken from the book Guía de pruebas para diagnóstico (Guide to Diagnostic Tests) by Diana Nicoll, Chuanyi Mark Lu and Stephen J. McPhee.

Common terminological inconsistencies:

• Using “patient” in some sections and “study subject” in others.
• Referring to the same medicine as “drug”, “investigational product” and “compound” without consistency.
• Translating “dose escalation” first as “dose increase” and then as “treatment increase”.
• Switching “adverse event” to “side effect” and later to “clinical complication”, creating ambiguity.
• Calling the “informed consent form” a “consent form” and then a “patient authorisation”.

These failures not only confuse investigators and participants, they can also invalidate documentation in the eyes of regulators. Avoiding them requires terminological consistency, medical expertise and quality control tools in translation.

Legal, clinical and reputational impact

A translation error can cause documents to be rejected by agencies such as the FDA or the EMA. In extreme cases these errors can force whole phases of a trial to be repeated, at significant cost in money and time.

Clinically, a poor translation can lead to overdosing, the wrong administration of medicines or misunderstandings in the reporting of adverse events (AE, SAE). The integrity of informed consent is also compromised.

What is more, errors of translation in clinical studies directly affect the reputation of the pharmaceutical company or the CRO. The confidence of patients, investigators and regulators rests on the accuracy of every word.

How to prevent translation errors in clinical studies

1. Specialist medical translators

Medical experience is crucial. Translators trained in pharmacology, bioethics or clinical medicine understand the context and acronyms such as CRF, ICF, SAE, ePRO, AE or GCP, which reduces these errors from the outset.

2. Quality control tools and glossaries

Using CAT tools, automated QA and standardised glossaries ensures consistency. Translation memory prevents contradictions and speeds up delivery without compromising quality.

3. Medical and legal review processes

Review and regulatory validation make sure no translation errors remain in these studies. This step is vital to avoid rejection by regulatory bodies.

Clinical translation services from Alos Soluciones Lingüísticas

At Alos Soluciones Lingüísticas we help prevent clinical trial translation errors through specialist language services for the biopharmaceutical industry and CROs. Our team is made up of medical translators, regulatory validators and multilingual project managers. We offer:

• Translation of ICFs, IBs, SOPs, CRFs, CSRs and SAE reports
• Medical review by clinical experts
• Regulatory validation under EMA, FDA and ICH rules
• Version management and document integrity
• Coordination of multilingual projects

Our processes are certified to ISO 17100 and we adapt to the requirements of each phase of the clinical study.

Translation errors in clinical studies are not simple grammatical slips: they represent a regulatory, health and financial risk. That is why specialist linguistic processes are vital, backed by technology, clinical experience and quality auditing.

Choosing a specialist translation provider such as Alos Soluciones Lingüísticas is an investment in accuracy, compliance and safety. Every well-translated word helps save time, resources and, above all, lives. Visit our website at:

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