Three terms in clinical trial documentation

Three terms have recently cropped up when I’ve been revising clinical trial documentation translated from Spanish to English. They’re not complex terms, but they do have standard or generally-accepted translations. Other solutions tend to jar on the ears.

  1. colaborador (noun)

This broad term is always a challenge to translate into English. In other subject areas, ‘contributor’, ‘colleague’ or even ‘collaborator’ may be valid solutions, but in the field of clinical trials, colaboradores are usually ‘subinvestigators’ or the ‘research team’.

Queda amparada la responsabilidad civil legal del investigador principal y de sus colaboradores.

This policy covers the civil liability of the principal investigator and his/her subinvestigators.

  1. criterio de evaluación/valoración

A clinical trial ‘endpoint’ or ‘outcome variable’ (but not ‘evaluation criterion’) describes a measurable event or outcome to define whether the intervention in question is effective.

Los criterios de valoración secundarios del estudio fueron la tasa global de respuesta, la supervivencia global y la seguridad.

The secondary endpoints of the study were overall response rate, overall survival and safety.

  1. fiabilidad entre evaluadores

The term evaluador is often translated as ‘evaluator’, but in this context (when a subjective outcome is under assessment) it should be translated as ‘rater’, ‘examiner’ or ‘observer’. And although ‘between’ is of course the correct translation for entre (‘reliability between raters’), English has a preference for using compound adjectives to shorten phrases, so ‘inter-rater reliability’ is the translation of choice.

La fiabilidad entre evaluadores de la medición de la presión inspiratoria máxima.

Inter-rater reliability in maximal inspiratory pressure measurement.

Diccionario inglés-español de investigación clínica

When you have doubts with ES-EN clinical trial terminology, be sure to check out the latest addition to Cosnautas, Diccionario inglés-español de investigación clínica, compiled by M.ª Verónica Saladrigas. Although it’s designed for into-Spanish translators, the dictionary is still valuable for reverse searches because many entries come with additional context and references to original sources, such as specific regulations and other publications.

See, for example, this screenshot of the entry for ‘subinvestigator’:

(Click the image for an enlarged version)
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1 Response to Three terms in clinical trial documentation

  1. Mora Elisei says:

    This is very helpful, thank you for sharing!!!

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