should know about Multilingual 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.
participants have to be informed of the following:
Results from previous
The kind of tests or treatments
involved and how they are given
Expected results in comparison to
Which stage, or phase, the trial is
How long the trial will
What side effects should be
What effects the trial may have on
participants' daily life
Will extra time be required of
Will participants have to be admitted
into a hospital and if so, for how long or often?
Will records remain confidential at all
Will withdrawal from the trial affect
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.
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.
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.
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
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