Medical documents are characterised by a high level of repetition of words and phrases, which means that paragraphs often appear very similar. This can be challenging for many early-career translators, as at many schools they are taught that writing should avoid repetition. However, this advice is more appropriate for novels, speeches, or creative writing. In medical translation, particularly in clinical trial and regulatory documentation, this approach can lead to more complications than benefits.
Why repetition is intentional in clinical trial documentation
In novels or creative writing, synonyms and longer words and phrases can help readers follow the narrative more easily and smoothly and, most importantly, support imagination. However, in clinical trial and regulatory documentation, they can make the text harder to interpret.
Alternative terms for the same disease, symptoms, or properties may raise uncertainty as to whether the author is still referring to the same concept. This issue may arise during translation if a translator or proofreader considers it preferable to smooth the text for stylistic reasons. In such cases, a well-written text may be transformed into a series of unnecessary questions. Sometimes, the ‘less elegant’ version is in fact the correct one.
How over-smoothing introduces ambiguity and errors
Over-smoothing can introduce issues that are not always immediately visible. While the text may appear more fluent or stylistically refined, this often comes at the expense of precision and terminological consistency. In clinical trial and regulatory documentation, even minor changes in wording can alter meaning, affect traceability, or create uncertainty for the reader. This is particularly critical when established regulatory terms are replaced with near-synonyms that are not fully equivalent in context or defined usage.
One common example is the substitution of standard regulatory terminology with more general or stylistically varied expressions. For instance, replacing 'adverse event’ with 'adverse reaction’ may seem like a natural stylistic improvement, but these terms are not always interchangeable in clinical documentation and may carry different regulatory implications. Similarly, terms such as 'subject’, 'participant’, and 'patient’ are context-dependent and defined within specific regulatory frameworks. Introducing variation where consistency is required can therefore lead to ambiguity or misinterpretation of the data.
Another frequent issue arises when terminology is deliberately varied for stylistic reasons, leading to a loss of consistency across a document. For example, alternating between 'blood samples’ and 'blood specimens’ or introducing different expressions for the same concept may appear to improve readability. However, in regulated content, such variation can disrupt terminological consistency and complicate traceability across documents, datasets, or audit trails.
Over-smoothing can also result in the dilution of controlled regulatory phrases. Standard expressions used in clinical documentation, such as 'study termination due to lack of efficacy’, carry specific meaning and are widely recognised within the regulatory context. Replacing them with more natural-sounding alternatives, such as 'the trial was stopped because it did not work well enough’, reduces precision and may render the text unsuitable for regulatory submission.
Synonyms vs. controlled terminology in medical writing
The ‘adverse events’ mentioned above have a colloquial equivalent that is used by both patients and healthcare professionals – ‘side effects’. Using it in everyday conversation is not a major problem; however, it is not an officially recognised medical term and cannot be used in clinical trial and regulatory documentation, nor in standard medical documentation. Unfortunately, it does happen that this colloquial term is included in terminology memories added to translation projects. This is usually due to insufficient checking of source terminology and the inclusion of all phrases, even if they are incorrect in medical writing, and without informing the client.
Regardless of whether it is translation or proofreading, it is good practice to inform the client about errors in source terminology, even if this is not formally part of the task. It helps to reinforce attention to consistency, but most importantly highlights the importance of using correct regulatory style.
This type of inconsistency can have a direct impact on quality control and regulatory review processes. Once non-standard terminology is embedded in translation memories or reused across documents, it may propagate across entire projects, reinforcing incorrect usage. This is particularly problematic in clinical trial documentation, where consistency of defined terms is essential for both accuracy and compliance.
Real risks in regulatory and clinical trial texts
Using inconsistent or non-approved terminology may result in the rejection of documentation by regulatory bodies such as the EMA (European Medicines Agency). Style guides precisely define the meaning of each term used in clinical trial and regulatory documentation, and these must be adhered to. In practice, such errors can lead to significant delays in research and additional costs.
Another risk is the misinterpretation of clinical data. A monitor or any other person reviewing the documentation may not be able to determine whether a given term refers to the same disease, product, or symptom. This may result from an incorrect understanding of the presented data and, again, lead to significant delays if the documentation is rejected.
Inconsistent terminology may also lead to incorrect risk assessment and inappropriate clinical decisions. It may additionally affect adverse event classification (e.g. SAE vs non-SAE), particularly when the terminology used does not align with established regulatory definitions. This can result in incorrect categorisation of safety data, which in turn may impact pharmacovigilance activities and reporting obligations. In a regulated environment, such inconsistencies are not merely linguistic issues but may have direct implications for patient safety and data integrity.
How to avoid over-smoothing in proofreading workflows
Avoiding over-smoothing requires a shift in perspective on the role of proofreading in medical and regulatory contexts. Rather than focusing on stylistic improvement, the primary objective should be to preserve meaning, ensure terminological consistency, and maintain alignment with the source text. In this setting, repetition is often intentional and should not be treated as a flaw to be corrected.
A key aspect of this approach is strict adherence to established terminology. Proofreaders should consistently refer to approved glossaries, termbases, and source documentation, and avoid introducing variation where a defined term already exists. Even when alternative expressions may appear more natural, they may not be appropriate in a regulatory context if they do not reflect standardised usage.
It is equally important to recognise when not to intervene. Repetitive or seemingly inelegant phrasing may in fact be correct and necessary, particularly in clinical trial documentation. Unnecessary changes made for stylistic reasons can disrupt consistency and introduce ambiguity, even if the revised text appears more fluent.
When uncertainty arises, it is preferable to raise a query rather than attempt to resolve the issue through rephrasing. Querying unclear or inconsistent source terminology allows for clarification and helps prevent the introduction of assumptions that may affect accuracy.
Attention should also be paid to the use of translation memories and previously approved content. While these resources are essential for maintaining consistency, they may also contain legacy errors or non-standard terminology. Blind reuse without verification can therefore reinforce incorrect usage across multiple documents and projects.
Ultimately, effective proofreading in this context prioritises consistency over stylistic variation. A final review should focus on whether terminology has been applied consistently and whether any unnecessary smoothing has been introduced. This approach not only improves linguistic quality but also supports regulatory compliance, facilitates review processes, and reduces the risk of misinterpretation.
If you would like to discuss medical translation, proofreading, medical writing, medical editing, or terminology consistency in clinical trial documentation, you can find more information about my services on the website or get in touch via email.