OBJECTIVES:As the use of existing translated clinical outcome assessments (COAs) across studies is common and continues to increase, appropriate documentation of the translation and linguistic validation processes utilized to create target language versions is essential. METHODS: A review of the contents of final reports and certifications for previously completed COA translations was conducted. Additional discussions with sponsors and CROs regarding final reports, and the prevalence of final report deliveries from linguistic validation providers across the industry were completed. RESULTS: Final reports for linguistic validation are not provided consistently across the industry. While some companies provide a final report for every project, upon further discussion with sponsors within the industry it was revealed that some companies do not automatically generate reports or provide them to sponsors upon completion of the linguistic validation process. Based upon regulatory expectations for review of translated COAs, it is recommended to utilize a final report which summarizes the overall linguistic validation project. This report should document the process used in detail, the reasoning for linguistic decisions at each stage, evidence of cognitive interviewing, cognitive interviewing population, demographic information of the respondents, a summary of the findings, the final formatted version of the questionnaire, and the relevant certification. CONCLUSIONS: Final reports for COA language versions provide valuable information needed to make critical decisions regarding the use of existing translations. Linguistic validation reports should be structured as a complete package addressing each item regulatory authorities require for review of translations, so the sponsor may easily include this in their submission packages. Final reports should be provided for every COA language version to document the translation and linguistic validation process completed.
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