Translating Study Reports – A GLP Draft Guidance

By LeAnna Pearson, Associate Director, QCR

The FDA has published a guide has been created for the translation of studies conducted by non-US testing facilities. The studies, which fall under Good Laboratory Practices, are expected to be translated from the facility's native language to English. The translation must be clear, accurate, complete, truthful, and follow written processes. The translated report should include a statement of certification requirements and sections such as the cover page, summary, materials and methods, results, discussion, conclusions, and appendices. The translator should have training in English and experience in native language translations, especially with medical and scientific documents. The sponsor or testing facility should have written procedures for the translation of studies and retain all related documents. Any amendment to the original final report should be translated separately.