Author
P. Mugüerza
Dr.Antonio Esteve Foundation
TORRE ESTEVEPasseig de la Zona Franca, 109
08038 Barcelona
Tel:
93 433 53 20
E-mail:
fundacion@esteve.org
The protocol is the detailed written record of the method used in clinical trial and it has a decisive influence on the study’s quality and reliability of results. Even though it is a scientific document, it is aimed at a wide range of readers, from the most specialized to the most general. Translation should involve rigor, precision and clarity, but these become even more important in the translation of clinical trial protocols, since a mistake can have serious consequences and even threaten the lives of the people being studied.
Pablo Mugüerza, a specialist in medical translations, is the editor of this manual whose aim is to facilitate the task of the translator of clinical trial protocols. These are usually dry and dense texts that are full of jargon and concepts known only by a handful of experts, and which test the skills of the best translator. The translation of these protocols involves attention to the subtleties of expression and turns of language, especially treacherous in section that are apparently simple, e.g. the data collection instruments, consent solicitation or patient outcomes.
In a systematic, logical and precise way, the Booklet of English-Spanish translation of clinical trial protocols, published by the Esteve Foundation, guides the reader through the different parts of a protocol, indicating at each step the keys to translating and illustrating each recommendation with practical examples. The literature that supports the material is broad and the tools recommended are abundant and easily accessible via the Internet.
In this way, and as recommended by the editor Pablo Mugüerza, this 23rd Esteve Foundation Notebook can be used not only as a guide to translate clinical trial protocols, but also in many other ways. The final glossary serves as a specialized dictionary of equivalents. Its practical section also serves to check concrete terms. Finally, it can be used as a reference, to find out more about the opinions of the authors or simply as a book to read to learn more about clinical trial protocols in general.
Full document | ||
Entire document | P. Mugüerza | [wpdm id=1584 type=”btn”] |
Chapters | ||
Prólogo | ML. Clark | [wpdm id=593 type=”btn”] |
Prólogo del autor | P. Mugüerza | [wpdm id=594 type=”btn”] |
1. Poética de la traducción de protocolos de ensayos clínicos | P. Mugüerza | [wpdm id=600 type=”btn”] |
1.1. ¿Qué es un ensayo clínico? ¿Qué es el protocolo de un ensayo? ¿Quién debería y quién redacta los protocolos? | P. Mugüerza | [wpdm id=595 type=”btn”] |
1.2. ¿Es necesario traducir los protocolos de los ensayos clínicos? ¿Quién debería y quién los traduce? | P. Mugüerza | [wpdm id=596 type=”btn”] |
1.3. ¿Es necesario revisar las traducciones de los protocolos de ensayos clínicos? ¿Quién debería y quién las revisa? | P. Mugüerza | [wpdm id=597 type=”btn”] |
1.4. ¿Es necesario leer los protocolos de los ensayos clínicos traducidos? ¿Quién debería y quién los lee? | P. Mugüerza | [wpdm id=598 type=”btn”] |
1.5. ¿Qué es validar una traducción de un protocolo de un ensayo clínico? ¿Quién debería y quién la valida? | P. Mugüerza | [wpdm id=599 type=”btn”] |
2. Decálogo del traductor de protocolos de ensayos clínicos | P. Mugüerza | [wpdm id=601 type=”btn”] |
3. Doce herramientas necesarias para traducir protocolos de ensayos clínicos | P. Mugüerza | [wpdm id=602 type=”btn”] |
4. ¿Por dónde empiezo? | P. Mugüerza | [wpdm id=603 type=”btn”] |
5. Dramatis personae | P. Mugüerza | [wpdm id=604 type=”btn”] |
6. El título del protocolo | P. Mugüerza | [wpdm id=605 type=”btn”] |
7. Objectives: objetivos | P. Mugüerza | [wpdm id=606 type=”btn”] |
8. Endpoints and outcome variables: criterios de valoración | P. Mugüerza | [wpdm id=607 type=”btn”] |
9. Patient selection, recruitment, and screening: selección de los pacientes | P. Mugüerza | [wpdm id=608 type=”btn”] |
10. Background and rationale: antecedentes y justificación | P. Mugüerza | [wpdm id=609 type=”btn”] |
11. Study drug: fármaco del estudio | P. Mugüerza | [wpdm id=610 type=”btn”] |
12. Pharmacokinetics, pharmacodynamics and genomics: farmacocinética, farmacodinámica y genómica | P. Mugüerza | [wpdm id=611 type=”btn”] |
13. Adverse events: acontecimientos adversos | P. Mugüerza | [wpdm id=612 type=”btn”] |
14. Statistics: estadística | P. Mugüerza | [wpdm id=613 type=”btn”] |
15. List of abbreviations: lista de abreviaturas | P. Mugüerza | [wpdm id=614 type=”btn”] |
16. Protocol identification and disclaimers: identificación del protocolo y avisos | P. Mugüerza | [wpdm id=615 type=”btn”] |
17. Otros apartados del protocolo | P. Mugüerza | [wpdm id=616 type=”btn”] |
Apéndice 1: Ejemplos comentados | P. Mugüerza | [wpdm id=617 type=”btn”] |
Apéndice 2: Glosario de equivalencias inglés-español | P. Mugüerza | [wpdm id=618 type=”btn”] |
Apéndice 3: Glosario de palabras tofu | P. Mugüerza | [wpdm id=619 type=”btn”] |
Bibliografía | P. Mugüerza | [wpdm id=620 type=”btn”] |