offers a wide gamut of opportunities right from translating medical reports, scientific papers, to labelling in pharmaceuticals, in clinical trials etc. that comply with various country specific regulatory requirements. One of the opportunities that has been growing of late is translating informed consent forms (ICF).
Clinical trial of newly discovered drugs has become a global business. With many non English speaking participants coming into the picture, drug companies particularly from US have to comply with FDA regulations of explaining the pros and cons of a clinical trial in the native language of the participants before undertaking it. FDA specifies that "the information that is given to the subject or the representative shall be in language understandable to the subject or the representative”. Further the consent must be obtained in writing from the subjects.
Informed consent forms are very technical in nature and must be translated with utmost care. Any mistake in translation can lead to misunderstanding by the participants in the clinical trial. Confusion in meaning would also result in violation of FDA regulations. High degree of professionalism is required in translating this type of medical documents.
The readability of the content by the subjects is very important. The wording must be in plain English or the native language as the case may be and the recommended standard for the language level is 4th to 8th grade of school. Any scientific or legal term must be explained in simple terms. The original and translated version must be ‘consistent’ which means the original style and content must be preserved. Even the font size and any footer information must be maintained. No loose translation like for example study or research substituted with treatment; replacement dose with additional dose; high BP with hypertension is permitted.
The translation must maintain first person account like ‘I’, ‘my’, ’me’ throughout the ICF. Translation memory tools identify repetitive text present in the source document and correlate it to previously translated segment to ensure consistency. This can speed up ICF translation and reduce cost and must be made use of as far as possible. Engaging professional translation service
providers with experience in this kind of translation jobs would guarantee that quality and standards are maintained as per FDA regulations.
To further ensure quality of translation of ICF, back translation i.e. from the target to source language of the translated documents by a second translator may be resorted to in addition to editing of the original translation. It would clearly bring out any misunderstanding of the subject matter by the translators. This may make translation time consuming but offers means to eliminate some of the errors that might have crept in the translation.