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18 Aug Translating clinical trial protocols

The translation of clinical trial protocols (CTPs) is a complicated business. CTPs are complex technical documents used to define and manage studies into the efficacy and safety of new treatments, drugs and medical devices. Errors in their translation can have grave consequences.

The difficulties you face as a CTP translator include:

Multi-disciplinary content: CTPs outline all elements of the study, not only the medical and pharmacological details, but also information related to laboratory conditions, logistics, statistics, and legal issues. An understanding of all aspects of a clinical trial is therefore a must.

Highly-specialist terminology: Aside from sheer quantity of technical terms, and the corresponding need for excellent research skills and access to specialist glossaries, clinical trials by their very nature exist at the forefront of the medical field. It may be the case that no established translation exists for a given concept.

Wide readership: CTPs are not soley read by specialist professionals, but by anybody involved in the running of a clinical trial. They must therefore be translated using clear, precise language that reads authentically in the target language, i.e. a more literal translation style, though tempting, is not necessarily a viable option.

Add to this the growing phenonemon of non-native authorship, and the usual contraints of time and money, and we begin to see that, although attractive to the more scientific-minded language professional, it is not a translation assignment that can be responsibly taken on by just any translator.

So what do we suggest? First and foremost, you must be honest about your knowledge base. As with any professional assignment, if in doubt, turn it down.

If you do accept the job, ensure your translation is proofread by a medical professional or other person with a degree in a field relevant to the clinical trial in question. No amount of Google searching or consulting of specialist glossaries can replace years of academic training or hands-on experience when it comes to correct terminology, phraseology and spotting inconsistencies or errors in the source text.

Try and incorporate a collaborative element to the translation process. Where possible, draw on the expertise of the people involved in the trial itself; the chances are they will know the appropriate terminology in the target language. Create a glossary and request approval of translations for key terms and concepts.

Above all, be ethical. CTPs can vary in scope, and your deadline may be more or less generous. Know your limits.