Medical Translation in Clinical Research

Medical translation services play a key role in clinical research. When a sponsor or CRO conducts a clinical study in a foreign country, many of the documents which are generated locally need to be translated back into the original language for the use of the clinical research associates (CRA) that manage the study.

Companies that conduct clinical testing internationally require that clinical trials conform to the World Medical Association’s Declaration of Helsinki. These ethics committees require that the investigator must convey the information, whether orally or in writing, in a language that is clearly understood by the people participating in the clinical studies. This usually includes translation of the Informed Consent Form (ICF) to the local language. For multi-center studies conducted in several countries, the ICF may need to translated into several languages.

Even if the clinical trial is only being conducted in one country, the ICF may still need to be translated into multiple languages. For example in the United States, many ICFs are translated into Spanish due to the large population of Hispanic Americans. In Israel, ICFs are typically translated into Arabic, Russian and Arabic due to the large populations in that country that speak those languages. In Belgium, ICFs may be translated into Flemish as well as French, since both of those languages are spoken there.

Some ethics committees also require that the ICF be back translated into the original language, as an extra quality validation method to ensure that the translated ICF is written correctly.

Depending on local regulatory requirements, the clinical protocol may need to be translated into the local language.

Multi-site clinical trials that run concurrently in several countries generally require packaging with multiple languages. The labels need to be reviewed and approved by the regulatory bodies in the countries where the trials will be conducted. For each phase of the clinical trial, new labels must be created and approved. The particulars must appear in at least the official language(s) of the Member State on the outer packaging of investigational medicinal products or, where there is no outer packaging, on the immediate packaging.

Here are some things you can consider when starting a medical translation project.

In country translators. Verify that the translation company uses specialized, in-country professional medical translators for your project. Nobody speaks and writes the local language better than the natives.

Translation certificate. Check with your IRB/ethics committee if a translation certificate is needed. Most medical translation companies will provide a translation certificate with each translation. The translation certificate is recognized by the IRB as testimony to the fact that the work is an accurate translation of the source.

Is back translation required? Some IRBs require a process of back translation. Some don’t. Check whether it is required for your clinical study.

Check the company quality process. Some company quality policies are ISO 9001:2008 certified. Some companies have EN 15038, which is a European translation certification. Ultimately, quality is the main concern in any medical translation project so make sure that the translation company quality policy meets your requirements.

About the author: David Grunwald is the Managing Director of GTS Translations, a translation company based in South Florida. GTS specializes in medical translation services for pharmaceutical companies and CROs. Find out more about GTS Translations on

http://www.gts-translation.com/services/medical_translation_services/