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What you should know about Multilingual Clinical Trials  


Clinical trials are subject to strict regulations and requirements. One of the main points those performing the trials have to consider is the fact that all participants have to be told in detail what is going to happen, how treatments will be administered, the expected benefits and possible side-effects (including the fact that unexpected, as yet unknown side-effects may occur), and so on. 


Essentially, participants have to be informed of the following: 

·         The study purpose 

·         Results from previous research 

·         The kind of tests or treatments involved and how they are given 

·         Expected results in comparison to standard treatments 

·         Which stage, or phase, the trial is in 

·         How long the trial will last 

·         What side effects should be expected 

·         What effects the trial may have on participants' daily life 

·         Will extra time be required of participants? 

·         Will participants have to be admitted into a hospital and if so, for how long or often? 

·         Will records remain confidential at all times? 

·         Will withdrawal from the trial affect their care? 


One of the most important documents participants of clinical trials must receive is the so called Informed Consent Form. The wording of these forms is strictly regulated and very carefully monitored. It has to ensure that each participant asked to sign the form can understand the form in no uncertain terms. 


This is especially important in multilingual clinical trials. Readability must be assured, as not being able to understand the content of informed consent forms means that the participant was not actually informed.  


It has been shown that speakers of different languages are twice as likely to misunderstand, or not understand at all, the same instructions as those given to native English speakers. This means that the forms must be written so any individual regardless of nationality can understand the terms and phrases used with ease.  


Translations need to be done in such a way that they are as as easily understandable as original English versions, taking local dialects, cultural differences, etc, into consideration.  


Translators are required to adhere to the original text and use the appropriate terms in all parts of the text in order to avoid misunderstanding or misinterpretation of any part of the text. Legal sections in particular must be translated exactly, rather than being modified by translators. 


It is also important for translators to make sure that the Statement of Consent part is written in the first person, just as it is within the original document. It should never be translated into a second person version. 


Getting translation of any documents, but in particular informed consent forms, relating to multilingual trials wrong can have serious consequences. In order to avoid this, translations should always be undertaken by professionally trained, expert translators. 


Our team of experts specializes in translating these vital documents from their original English version into a wide range of Indian languages, from Hindi, Bengali and Urdu through Gujarati, Tamil, Marathi, Telegu or Oriya to Malayalam, Nepali Punjabi or Kannada in compliance with those essential requirements.
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Hindi, Bengali, Kananda, Gujarati, Punjabi, Urdu, Tamil, Telegu, Malayalam, Marathi, Assamese, Oriya, Sanskrit translation by native translators

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