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Part 3: Consistency and Terminology in Regulatory Medical Writing

 

 

 

Consistency Within a Single Document

Consistency is a fundamental requirement in regulatory writing. In the context of translation, inconsistencies in the source document are a common cause of inconsistencies in the target document, especially when a client glossary must be strictly followed. Typical examples include:

• The terms IMP, study drug and study treatment may appear in a protocol or an IB. These could be translated into French as "médicament expérimental", "médicament à l’étude" or "traitement à l’étude", which may result in terminology inconsistency in the French version as well. Only "médicament expérimental" is the official term, and it must be used consistently in regulatory documents intended for healthcare professionals as defined in the ANSM clinical trials glossary.

• The terms patient, subject and participant are sometimes used inconsistently in the English version, and often translated systematically in French as "patient", "sujet" and "participant" in the same document. Current regulatory terminology, including the French version of European Union Clinical Trials Regulation 536/2014 and French Good Clinical Practice (GCP, "Bonnes pratiques cliniques pour les recherches biomédicales") favors "participant". This latter is a simplified term encompassing the French GCP concept of "personnes qui se prêtent à la recherche", and includes both patients and healthy volunteers. The term "sujet" is also inclusive and remains acceptable and widely used in French regulatory documentation and guidelines such as the French version of the Good Clinical Practice of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH GCP). Nevertheless, recent trends favor "participant," which has the advantage of being both inclusive and more ethically neutral. Note that for SmPC, "patient" remains the most suitable term, except in fixed phrasings such as "sujets âgés", which is commonly used in the French SmPC. Under no circumstances should "patients âgés", "sujets âgés" and "population âgée" be used interchangeably within the same document.

• Although the English term active ingredient is not recommended by the EMA in the PI, both active ingredient and active substance may appear in English regulatory documents and glossaries. Such variation can lead to inconsistencies when translating into French. In any French regulatory document, alternating between "substance active" and "principe actif" should be avoided. For submissions intended for France, "substance active" is always preferred. Note that "ingrédient actif" is correct in Canadian French but not acceptable in French for France, while "composant actif" is incorrect and should not be used.

A glossary should not be followed blindly if inconsistencies already exist in the source document. Any such issues must be flagged, with a clear recommendation for consistent terminology throughout both the source and target documents.

 

Consistency Across Related Documents

Terminological consistency should also be maintained across multiple related documents where applicable to prevent ambiguity and ensure regulatory compliance: the same validated term should be used for the same concept, as inconsistencies represent a major regulatory vulnerability.

For example, the PI package (SmPC/PL/Labeling) is considered a single and consistent regulatory set. Core elements must be strictly aligned across all components, including ATC classification, substance names including INN and excipients, units, therapeutic indications and EDQM Standard Terms (routes of administration, pharmaceutical forms and packaging).

However, the recommendations, style and wordings are not identical between the SmPC and the PL, as these documents target different audiences (healthcare professionals versus lay audiences). While the underlying information and regulatory content must remain strictly compliant and consistent in both documents, terminology and level of technicality must be tailored to the intended reader. Failing to make this distinction may result in oversimplified documents intended for healthcare professionals (e.g. SmPC) or excessively technical patient-facing materials (e.g. PL). Therefore, although consistency across the PI (SmPC/PL/Labeling) is mandatory, adaptation of terminology is not only encouraged but compulsory (a more detailed discussion of the linguistic and terminological specificities of the PL will be addressed in a separate article regarding regulated medical content for lay audiences).

Consistency extends outside the PI to all documents related to a clinical trial, including the statistical analysis plan (SAP), clinical study report (CSR), protocol and IB. Typical examples include:

• Endpoints should be defined identically in all documents related to a clinical trial, including protocol, SAP and CSR, ensuring that thresholds and conceptual definitions remain consistent and unaltered.

• Disease names must remain identical across all documents (e.g. IB, protocol, PI). Synonyms should not be used interchangeably, and harmonization is essential. Examples:

  • "lupus érythémateux disséminé" versus "lupus érythémateux systémique".

  • "syndrome d'apnée du sommeil" versus "apnée du sommeil" versus "syndrome d'apnée obstructive du sommeil" versus "syndrome d'apnée-hypopnée obstructive du sommeil".

  • "sclérose latérale amyotrophique" versus "maladie de Charcot".

Note that eponymous disease names should be avoided in accordance with international Anatomical Terminology (Terminologia Anatomica) rules.

As a general principle, the disease name should remain strictly identical to the one used in the clinical trial title where available, and be applied consistently across all related documents.
When several French denominations exist or when clarification is needed, reference should then be made to the World Health Organization International Classification of Diseases (WHO ICD) and to the "Dictionnaire de l’Académie de médecine" (French Academy of Medicine dictionary). The latter provides validated French medical terminology with clear definitions and is particularly useful to confirm that medical concepts and conditions are officially recognized in French medical usage (e.g. those specified in inclusion and exclusion criteria in a protocol). In practice, consulting both resources in parallel helps ensure terminological consistency and alignment across references.

 

Style and Neutrality in Regulatory Medical Writing

 

• During translation or drafting, promotional formulations (e.g. "les données démontrent clairement l’efficacité du traitement") or wording conveying opinion, judgment or assertiveness (e.g. "prometteur", "encourageant", "prouvé", "remarquable", "très sûr", "bien toléré", "excellent") must be avoided. Subjective adjectives or stylistic embellishments (e.g. "modeste", "excessif", "violent") should also be excluded. Regulatory documents must rely on neutral, descriptive and verifiable formulations (e.g. "le critère de jugement principal a été atteint…" or "une augmentation statistiquement significative a été observée").

• Adverbs should be used sparingly, as vague qualifiers such as "globalement", "généralement", "majoritairement" or "principalement" may introduce ambiguity.

• Literary or narrative constructions should be avoided. For example:

  • "la prudence est de mise…" → "X doit être utilisé avec prudence"/l’utilisation de X nécessite des précautions particulières".

  • "…doit être soigneusement contrôlé" → "…doit être étroitement surveillé".

  • "fièvre importante" → "fièvre élevée".

• Superfluous literary connectors that unnecessarily weigh down the text should be avoided and replaced with punctuation or simple linking words where appropriate. Expressions such as "il convient de noter" or "en ce qui concerne…" rarely add regulatory value. Each expression must serve an informative purpose.

• Overly simplistic terms and plain language principles are not applicable to SmPC. Technical terminology appropriate to the clinical and regulatory context must always be used, for example:

  • "mettre la vie en danger" → "mettre en jeu le pronostic vital".

  • "problèmes" or "perturbations" → context-appropriate technical terms should be considered, e.g. "troubles hépatiques", "altération de la fonction rénale", "dysfonctionnement du ventricule gauche", "déséquilibre hormonal", "déséquilibre du microbiote" (or preferably "dysbiose"), "états pathologiques".

• Descriptive and neutral formulations should be favored over nominal adjectives found in older SmPC that define individuals solely by their disease or condition, for example:

  • "insuffisants rénaux" → "patients/sujets présentant une insuffisance rénale".

  • "patients diabétiques" → "patients atteints de diabète".

  • "patients cancéreux"→ "patients atteints de cancer".

Technical terminology and wording must always be maintained. Expressions aimed at lay audiences such as "souffrant de", "vivant avec" or "en situation de" are inappropriate in regulatory documents intended for healthcare professionals and should be avoided.

 

Terminology Evolution

Standardized phrasings in EMA-approved (and ANSM-approved) SmPC must be preserved while avoiding outdated regulatory expressions. Therefore, recently approved ones should be consulted via the EMA medicine finder and the ANSM public medicine database ("répertoire des médicaments de l’ANSM") to follow current practice, focusing on the SmPC of medicinal products within the same pharmacotherapeutic group, mechanism of action or therapeutic indication. Medical terminology and regulatory writing practices evolve, and this evolution should not be overlooked. Typical examples include:

• The expression "rapport bénéfice-risque" (benefit/risk balance) is gradually being replaced by "balance bénéfice-risque", which is increasingly used in recent French regulatory documents.

• Avoid outdated terms and obsolete denominations as identified by the "Académie de médecine".

• Be aware of evolving medical terminology increasingly reflected in recent scientific and regulatory literature, even in the absence of formal recommendations. Typical examples include:

  • The growing use of "microbiote" instead of "flore".

  • The use of "périmenopause" instead of "préménopause". While some French terminology authorities, such as Quebec Office of the French Language ("Office québécois de la langue française", OQLF), draw subtle distinctions between both terms, current usage in recent literature and regulatory documents tends to favor "périmenopause".

• Prefer Terminologia Anatomica terms for anatomical structures, procedures or diseases related to anatomical regions, even if they are not yet fully established in routine clinical practice, in order to ensure alignment with internationally standardized anatomical terminology and long-term regulatory consistency. Examples include:

  • "nœuds lymphatiques" versus "ganglions lymphatiques".

  • "liquide cérébro-spinal" versus "liquide céphalo-rachidien" (this latter being considered obsolete by the "Académie de médecine").

  • "tonsillectomie" versus "amygdalectomie".

  • "fibrillation atriale" versus "fibrillation auriculaire".

If there is any doubt as to the clarity of a Terminologia Anatomica term for all healthcare professionals, a robust approach is to introduce the former term in parentheses at its first occurrence, e.g. "fibrillation atriale (également appelée fibrillation auriculaire)", while maintaining the standardized term consistently throughout the remainder of the document. Mixing old and new anatomical terminology must be avoided to maintain consistency.

 

Tense Consistency

Within a single clinical trial document (e.g. protocol, IB, SmPC), verb tenses must remain consistent and should not alternate between present and future.
In French regulatory writing, the present tense is the standard tense used to describe general procedures, recommendations and therapeutic or pharmacological effects, as it ensures fluency, smoothness and a natural authoritative tone. Although the influence of English source documents may lead to the use of the future tense in French, unjustified alternation of tenses is not acceptable and should be systematically avoided.

 

The consistency principle also applies to the management of calques and anglicisms, which represent a specific and recurrent source of linguistic risk in French regulatory documents and are addressed separately in the following section.
 

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