This is a document intended for ethics committees, regulatory authorities, researchers and monitors and the research team. Having explained these two concepts, I will now get to the point and discuss the subject at hand:translating a clinical trial protocol.Firstly, as translators, we have to consider the following facts: The structure and content of the protocol must comply with the provisions of Royal Decree 223/2004, of 6 February, governing clinical drug trials conducted in Spain. This is a document that outlines the objectives, design, methodology, statistical considerations and organisation of a trial. « Compliance with this standard provides public assurance that the rights, safety and wellbeing of trial subjects are protected, consistent with the principles of the Declaration of Helsinki, also guaranteeing that the clinical trial data are credible ».Ī « clinical trial protocol » can briefly be defined as « the set of instructions and relevant data that the researchers must follow and know in order to conduct a clinical trial ». This is an international ethical and scientific quality standard for the design, conducting, recording and dissemination of clinical trials involving human beings. The Good Clinical Practice guidelines (GCP) exist for that purpose. There must therefore be three dimensions to a clinical trial:the methodological or scientific aspect, the ethical dimension and the legal or regulatory aspect, because it’s not only necessary to guarantee the reliability of the data, but the patients’ integrity and rights must also be protected. A clinical trial still remains an « experiment » that involves human beings, and the very fact that the experiments are with people means that it has ethical implications that require extreme care, bearing in mind the possible impact of its results, since they may determine what treatment is given to a huge number of patients. Clinical trials are a way of scientifically meeting the ethical need to guarantee the effectiveness and safety of the treatment received by patients and they offer a controlled, objective and reproducible method for measuring the effects of a treatment on health, thus making it possible to objectively determine its usefulness. To obtain approval for a clinical trial, it is necessary to submit the relevant application form, together with a number of mandatory documents, including the protocol.īefore I continue, I should define and briefly explain the terms « clinical trial » and « clinical trial protocol » that I referred to in the previous paragraph.Ī « clinical trial » is, in its broadest sense, « any research performed on human beings ».When a new active principle has undergone sufficient testing on in vitro models and experimental models (animals), clinical research on humans begins: the clinical trial. In Spain, biomedical research through clinical trials is subject to legislation so, when a pharmaceutical laboratory wants to perform a clinical trial in our country, it has to obtain proper authorisation to do so first. If we are given the job of translating a clinical trial protocol, we can’t simply approach the task as if it were a highly specialised medical text. ![]() Today, also in general terms, I will be discussingthe translation of clinical trial protocols. On this occasion, I will focus the article on a more specific aspect of this vast field. ![]() In the article that I published a few months ago entitled An Introduction to Medical Translation I offered a brief general introduction to this specialised field of translation. ![]() By Cristina Ponte, Quality Controller at Nóvalo
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