If a clinical trial is a scientific experiment that is carried out to answer a medical question, the protocol is the document that contains the instructions to carry it out, from its objective, evaluation criteria and hypotheses to its admission and development criteria. There is a medical part, in which the disease under treatment is analyzed, but it also contains administrative, legal, statistical and epidemiological sections and on the rights and obligations of the parties.
The protocol has a decisive influence on the quality of the study and on the reliability of the results. It is a scientific document but intended for very diverse readers, from the most specialized to the most common and current. If rigor, precision and clarity can be required of all translations, these attributes become even more important in clinical trial protocols, since an error can have serious consequences and even endanger the lives of the people studied.
After a first edition edited in 2012 of which 2,500 paper copies were distributed, the medical specialist in medical translation Pablo Mugüerza now publishes the second edition of the Manual of English-Spanish translation of clinical trial protocols, the Notebook of the Dr. Foundation Antoni Esteve who seeks to facilitate the task of translating clinical trial protocols.
These are arid and dense texts, full of technicalities and concepts barely known by a handful of experts, which test the skills of the best translator. The task, therefore, involves paying attention to the expressive subtleties and twists of the language, especially treacherous in the simplest-looking parts such as the data collection instruments, the request for consent or the patient’s evolution template.
In a systematic, logical and critical way, this Manual of English-Spanish translation of clinical trial protocols guides the reader through the different parts of the protocol, indicating in each of them the keys to the translation and illustrating each recommendation with practical examples. The bibliography on which the material is based is current and numerous and the recommended instruments are abundant and easily accessible through the internet.
Among the novelties of this second edition, Mugüerza includes the terminological novelties that appear in the new Royal Decree 1090/2015, “which regulates clinical trials with drugs, the Research Ethics Committees with drugs and the Spanish Registry of Clinical studies”. It also offers a detailed extension of all the sections of the second part of the manual, which deals with practical aspects of the English-Spanish translation of clinical trial protocols, from the tools necessary to translate these documents to the translation of elements such as statistics or adverse events.
In this way, the manual can be used as a reading book, to know everything about the protocols and to know the author’s translation proposals for the most difficult terms in each section of the protocol. Also as a specialized equivalency dictionary, by consulting the glossary at the end of the text, or as a reference book on various aspects of the translation of the protocols presented in the appendices. Finally, it can be used as a guide to translate clinical trial protocols.
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