Internal Review — Confidential | Subject: Translation-related deviations in multi-regional clinical trials (FY 2023–2024) | Scope: 14 trials across EMEA and LATAM
Over the past eighteen months, our division has conducted post-submission reviews of 14 multi-regional clinical trials that involved translation of regulatory documents, informed consent forms, case report forms, and patient-reported outcome instruments into a combined 23 languages. Below are the principal findings.
Finding 1: Informed consent forms — the consent that isn't
In four of the 14 trials reviewed, the translated ICF contained risk descriptions that were technically accurate but communicated a materially different level of risk than the source English text. The English source used hedged language ("may increase the risk of," "in some cases has been associated with"), and the translation removed the hedging or replaced it with stronger language implying certainty.
Brazil ethics committee query: Full ICF revision, re-approval by local ethics committee, re-consent of 347 enrolled participants. Approximately 11 weeks added to trial timeline.
Finding 2: Case report forms — the data integrity chain
In three trials, translated CRF response options had been "simplified." A five-point severity scale ("None / Mild / Moderate / Severe / Life-threatening") was translated into a language where equivalent terms did not map to a five-point hierarchy, and the translator collapsed the scale to four points.
Consequence: English sites collected data on 5 points; translated sites effectively used 4. Database lock delayed by 6 weeks. Required post-hoc mapping and supplementary statistical analysis.
Finding 3: Medication guides — readability beyond accuracy
Patient-facing translations consistently exceeded the reading level of the target population. Medication guides originally at a 6th-grade reading level became 10th-grade or higher in translation. The EU's PIL readability guideline requires information to be "clear and legible" and designed to facilitate patient understanding. A PIL that meets accuracy but fails readability is non-compliant regardless of precision.
Finding 4: Regulatory submissions — the localization that isn't
Two submissions encountered delays because translated regulatory documents referenced EU-specific frameworks in non-EU markets. An investigator's brochure prepared for EMA follows different structure and guidelines than one for China's NMPA. Accurate translation of the content without localization of the regulatory context produced submissions that were linguistically correct but jurisdictionally inappropriate.
Synthesis
Life sciences translation failures are rarely failures of language proficiency. They are failures of domain expertise. Generalist translators do not have the specialized knowledge to navigate the regulatory, clinical, and patient-safety dimensions that make life sciences localization fundamentally different from general medical translation.
Cumulative delay across 14 trials: approximately 28 weeks. At Artlangs Translation, life sciences localization is delivered by linguists with demonstrated expertise in clinical trials, regulatory affairs, and pharmaceutical documentation — supported by subject matter expert review, risk-language severity auditing, and reading-level verification. Across 230+ languages.
