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Part 4: Management of Calques and Anglicisms

 

 

Fidelity to Source and Regulatory French Standards

Ensuring accuracy and fidelity to the source document is essential for maintaining conceptual equivalence and correctly rendering English terms. At the same time, it is important to recognize that medical French is a discipline in its own right, not merely a derivative of English regulatory phrasing.

Accuracy in regulatory contexts must never compromise clinical readability. A French SmPC may be fully QRD-compliant, yet sound non-idiomatic, overly literal or contain hidden anglicisms. Balancing regulatory compliance with adherence to linguistic conventions, while preserving clarity, is a core challenge of modern regulatory writing.

Regulatory French is medical and scientific French, not an Anglicized sub-language tolerated merely on the grounds that it is 'regulatory'. Authorities such as EMA or ANSM require precision, terminological consistency and the absence of ambiguity, not the mechanical transfer of English phrasing or calques.

 

Acceptable and Unacceptable Calques

A calque or an anglicism is acceptable only if it is deeply entrenched in regulatory usage or almost indisputable (e.g. "amendement au/du protocole", "randomisation", "aveugle", "bras", "comorbidité") or required by applicable normative frameworks (e.g. MedDRA coding where required, fixed SmPC wording, officially defined endpoints). Otherwise, calques can impoverish French, reduce linguistic flexibility and blur clinical meaning.
Linguistic precision is therefore essential: avoid literal translation of medical English, and use idiomatic French to ensure comprehension by the target audience, including healthcare professionals.

 

Terminological Localization and Anglicisms

Some anglicisms or calques are widely accepted in Canadian French. However, they are not recommended in French for France and can even create confusion for French healthcare professionals. Examples commonly observed in SmPC include:

• "Formule sanguine complète (FSC)": calqued from English complete blood count, widely used in Canadian French → "numération formule sanguine" (NFS), idiomatic in France; "hémogramme" is also valid in both French variants.
• "Niveau": calqued from English level, when referring to blood parameters or medicine plasma concentrations → "taux" or "concentrations plasmatiques", sometimes "teneur" depending on context.
• "Titrer la dose" → "adapter" or "ajuster la dose", referring to the prescribed medicine posology.

Even when such calques are common, they should not be normalized or used indiscriminately. Medical French should be respected while carefully managing regional terminology variations.

 

Practical Recommendations

Some anglicisms are deeply entrenched in French regulatory usage, and it is not realistic to attempt to eliminate them entirely. There is an inherent tension between clinical or even regulatory practice and linguistic recommendations, which cannot always be fully resolved. Therefore, a pragmatic and conciliatory approach can be applied, whereby anglicisms can be grouped into three categories from an operational standpoint:

• Anglicisms to be retained: when an anglicism or an English term must be used, it should be retained without modification. Typical examples include:
  • "amendement au/du protocole," which is used in daily practice as well as in official texts such as French GCP.
  • MedDRA terms for adverse events or adverse reactions, e.g. PT rash, which remains an anglicism for "éruption cutanée".
  • Some terms, though rare, are better understood in English by French healthcare professionals, such as spotting (which is recognized by the "Académie de médecine"). As a good practice, the French equivalent term (e.g. "microrragie") could be written first, with the English term in parentheses for clarity.
  • Certain English abbreviations can, and sometimes should, be used as they are immediately recognized in French-speaking medical practice and are often the only forms understood by French healthcare professionals (e.g. LDL, HDL, TSH, INR, FSH, ADH). As a good practice, the French full term should be written first, followed by the English abbreviation in parentheses at its first occurrence. If a glossary requires the French abbreviation, this can be flagged to the client, and both abbreviations may be included in parentheses.
  • Other English abbreviations specific to clinical trial documentation, such as CRF/eCRF (Case Report Form/electronic Case Report Form), are widely understood by French healthcare professionals. They remain acceptable in operational documents, particularly if included in a validated glossary. However, the standard French denomination "cahier d’observation" should always be retained as the primary term, while the officially recommended French term "cahier de recherche formalisé" may be referenced in terminology-focused contexts (see section 4.6 for more details).

• Anglicisms to be avoided: other unjustified anglicisms should be strictly avoided, especially those linguistically incorrect or scientifically misleading. Examples include:

  • "Supporter" as a translation of support should be avoided in French medical writing. Appropriate alternatives in the context of clinical or scientific data include "étayer", "confirmer" or "corroborer", depending on the strength and nature of the evidence.
  • "Dommage" as a calque of damage should be avoided. Depending on context, prefer "atteinte", "altération" or "dégradation" (e.g. "atteinte oculaire", "altération de la fonction hépatique", "dégradation de l’état clinique").
  • The term "dysfonction" is often imported directly from the English term dysfunction. In French medical writing, "dysfonctionnement" is generally preferred when describing an alteration of an organ or physiological function, for example: "dysfonction ventriculaire" → "dysfonctionnement ventriculaire".
• Anglicisms commonly used in practice and considered "tolerated", for which French alternatives are always preferable. Examples include:
  • "initier un traitement" → "instaurer un traitement".
  • "développer une maladie, des symptômes ou une réaction" → "contracter une maladie ou une infection, "apparition d’une maladie" (especially for chronic conditions), "présenter des symptômes" or "manifester une réaction".
  • "diabète insuffisamment contrôlé" → "diabète mal équilibré".
  • "maladie non contrôlée" → "maladie non stabilisée".
  • "site infectieux" → "foyer infectieux".

The rule is simple: whenever it is possible to replace an anglicism with its French equivalent, and it is fully comprehensible by healthcare professionals, the French term must be preferred.

 

French Idiomatic Phrasing

• It is crucial to use French idiomatic phrasing and avoid constructions too close to English that may result in unnatural medical French. Examples commonly observed include:
  • "altérer l’efficacité" → "diminuer l’efficacité".
  • "données robustes" → "données solides".
  • "détérioration de la fonction rénale" → "altération de la fonction rénale".
  • "signe, symptôme ou tableau clinique suggestif d’un diagnostic" → "signe ou symptôme évocateur d’un diagnostic".
  • "relation possible entre la réaction et le médicament" → "lien causal possible entre la réaction et le médicament".
  • "réduction graduelle de la dose" → "réduction progressive de la dose".
  • "minimiser les risques" → "réduire les risques" (or, depending on context, "limiter les risques"). In regulatory and clinical contexts, "réduire les risques" is preferred, as it aligns with the standard concept "mesures de réduction du risque" (risk minimisation/reduction measures), and often refers to objective and actionable risk management plan or strategies.
  • "contrôler les symptômes" → "réduire les symptômes" (or, depending on context, "atténuer" or "soulager les symptômes"). "Réduire les symptômes" aligns better with measurable clinical outcomes than "soulager" or "atténuer", which may be perceived as more subjective, and therefore often more appropriate in patient-facing materials such as patient-reported outcome (PRO) questionnaires or PL. The expression "amélioration des symptômes " is widely used in regulatory contexts. From a strictly linguistic perspective, this formulation may nevertheless be debated, as symptoms are generally described as being reduced in intensity or alleviated rather than "improved".

 

French Linguistic Recommendations

It is also highly recommended to avoid terms deemed scientifically improper in French or discouraged by the "Académie de médecine" and official French terminology authorities, even if they are commonly used or still referred to in some glossaries. Common examples include:

• • "naïf de traitement" → "vierge de tout traitement" (the officially recommended phrasing), or depending on context, "non préalablement traité" or "n’ayant jamais reçu de traitement".
  • "contrôlé par placebo" → " contrôlé contre placebo".
  • "pathologies" (considered improper by the "Académie de médecine" despite common usage) → "maladies".
  • interchangeable use of "coronaire" and "coronarien".

While medical terminology falls under the scope of the "Académie de médecine" and officially recognized authorities, regulatory medical French should still comply with the recommendations of the "Académie française" (French Academy) for general language recommendations. Typical examples in medical writing include:

• • Prefer "effets", "influence" or "répercussions" depending on context, instead of "impact".
  • Prefer "en matière de" instead of "en termes de".
  • "Éligible" in French literally means "who can be elected". In medicine, particularly in clinical trials ("critères d’éligibilité"), it is commonly used but linguistically not recommended. More linguistically precise alternatives include: "participant admissible à une étude/un essai clinique", "patient/sujet pouvant bénéficier du médicament expérimental" or simply "critères d’inclusion et d’exclusion", depending on context. The term "admissible", when referring to a potential participant, aligns with French version of the ICH GCP standardized terminology.
  • The expression "débuter une grossesse" is widely used in regulatory documents, although linguistically incorrect according to the recommendation of "Académie française". More precise alternatives include, depending on context, "les femmes qui souhaitent concevoir" and "en début de grossesse" (or for patient-facing materials "envisager une grossesse"→ "si vous envisagez une grossesse…").

While scientifically imprecsie or linguistically discouraged terms should generally be avoided, certain officially recommended terms may remain marginal in clinical practice and not yet adopted by health authorities. In such cases, a pragmatic and context-driven approach should be warranted.

A typical example in clinical trial documentation is the French designation of the (electronic) case report form (CRF or eCRF where applicable). In current regulatory usage, including documents issued by ANSM, the term "cahier d’observation" (or "cahier d’observation électronique") is predominantly used. "Cahier de recherche formalisé" is recommended by French terminological authorities such as "Académie de médecine" and "France Terme". However, it remains rare in routine regulatory documentation and may not be immediately recognized by all French healthcare professionals. Accordingly, "cahier d’observation" (or "cahier d’observation électronique") should be used as the primary denomination in clinical trial and regulatory documentation.

Note that the English abbreviations CRF and eCRF are also widely used and readily understood in French-speaking clinical settings. Despite being an anglicism, they may be added in parentheses at first occurrence to ensure immediate comprehension, particularly in operational documents intended for healthcare professionals (e.g. protocols or IB). On the other hand, the officially recommended French denomination "cahier de recherche formalisé" may be included in parentheses at first occurrence (e.g. "également dénommé cahier de recherche formalisé") in terminology-focused documents such as terminology audit reports, or where explicitly required by the client (e.g. validated internal glossary); but it should not replace "cahier d’observation" as the primary term. This approach ensures regulatory alignment, clarity for the reader as well as transparent and consistent terminology across documents.

As a general principle, regulatory medical writing should follow the recommendations of "Académie de médecine" and French linguistic authorities. However, where a divergence exists between these recommendations and the terminology used in official regulatory documentation by health authorities (e.g. ANSM, EMA), and consistently applied in French-speaking clinical practice, priority should be given to the latter in operational regulatory documents, provided that the term is neither scientifically imprecise nor misleading. This context-driven and operationally grounded approach preserves clarity, readability and regulatory consistency.

 

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