Patient Reported Outcomes (PROs) place unique and highly specialized demands on translation service providers. Gained in Translation, published in Future Pharmaceuticals, provides a good overview of the documents requiring translation, the process steps included, and some of the unique challenges present in international clinical trials.
Of course, one the topics that's being addressed is whether or not back-translations are needed. As we have seen before, strong opinions surround this discussion.
For a good overview of this topic, be sure to read this informative article.
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