If the documentation for running the trial is provided in English only, this may influence the number of researchers, administrators and ethics committee members and CRO staff in a non-English-speaking country who actually read the protocol carefully. Could protocol violations or errors in data collection and recording occur because documents are not available in the researchers’ first language? Is there a risk that some data from a trial might turn out to be useless if an investigator misunderstands the documents? Who would be responsible if any participants in the trial were inconvenienced or harmed because the documents were not available in the local language? Would the insurance policy the sponsor subscribes cover the cost of compensation to patients or other parties for damages caused by inadequate or missing translation and adaptation into the local language? These are questions that should concern clinical trial experts and clinical research regulators in any country where English is not the main language. Each country where research is conducted has its own guidelines, legal requirements and approval processes. Documents such as informed volunteer consent forms, researchers' brochures and clinical summary reports that may be accepted in international regions may need to be translated into local languages. An important criterion for a successful clinical study is the timely and accurate translation of documents.

References:

1. Matthias Steiert, Ph.D., Elanna Mariniello, B.A., and Afaf Steiert, M.Sc. The Role Of Language Translation In Clinical Trials. Life Science Leader. February 27, 2013

2.  Karen Shashok. Should clinical trial protocols be translated into the researchers’ local language? Ethics, science, and the language of research.  Panace@. Vol. IX, (27), 1, p 1-3, 2008