The impact of the new EU Clinical Trial Regulation on language translation

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The impact of the new EU Clinical Trial Regulation on language translation

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xysoom

Posted 29 May 2023 - 06:02 AM

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The impact of the new EU Clinical Trial Regulation on language translation

The EU Clinical Trial Regulation (CTR) and Clinical Trial Information System (CTIS) are simplifying the process of clinical trials in the EU while improving transparency and protecting participants. The regulation must be applied to all clinical trials conducted in the EU, regardless of whether the sponsor or the trial participants are based in the EU. When it comes to translations, the EU CTR has a significant impact on the requirements for clinical trials conducted in the EU.Get more news about clinical trials translation company,you can vist our website!

The CTR states that all documents related to a clinical trial must be translated into the language(s) of the trial participants. This means that sponsors of clinical trials in the EU must make sure that all relevant documents are translated into the languages spoken by the trial participants. Moreover, the EU CTR requires that all documents submitted to regulatory authorities in the EU must be translated into the official language(s) of the member state where the trial is being held.

It's important to note that translations must be done by professional translators and reviewed by someone with a good understanding of the scientific content. This ensures that translations are accurate and consistent with the original documents. The CTR also requires sponsors to keep records of all translations, including the name of the translator, the date of the translation, and any changes made during the translation process.

While the EU CTR's translation requirements can be seen as an added burden to the already complex process of conducting a clinical trial, it ensures that patient-facing materials are easily understood by the trial participants and that the scientific content is accurately translated for regulatory authorities.