Translation of legal and regulatory documents for multinational clinical trials in Spain: More than just protocols

Managing a multinational clinical trial in Spain requires the translation of several legal, regulatory and financial documents. The two most important texts, which have received the most attention, are the protocol and the patient information sheet/informed consent form, but translators who work in the pharmaceutical industry also deal with other types of documents. Based on the corpus compiled by the author over his ten years of experience, this article classifies and analyzes the other legal and regulatory genres which are translated for clinical trials: the protocol amendment, the letter of delegation, the Ethics Committee opinion, the site management agreement, the power of attorney and the clinical trial agreement. The author provides advice, tips and comments to assist in translating these texts.