clinical trials
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Why clinical trial documentation is rejected by regulatory authorities (EMA, FDA)
Clinical trial documentation is crucial for patient safety, compliance with Good Clinical Practice, and the validity of research findings and treatments. It enables ongoing monitoring of the study and helps identify inconsistencies with the protocol. However, even minor issues can lead to rejection by regulatory authorities.
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Over-Smoothing in Medical Translation: A Critical Mistake in Clinical Trial Texts and Regulatory Writing
Medical documents are characterised by a high level of repetition of words and phrases, which means that paragraphs often appear very similar. This can be challenging for many early-career translators, as at many schools they are taught that writing should avoid repetition.