US Clinical Trial Translation
In the US, unrealistically high MAPI standards are less of a problem then the general lack of professional translation standards often employed in the clinical trial process.
In most stateside trials, translation is notable for its absence. Those who don’t understand English are generally excluded from studies. This is unfortunate, but understandable too. Declarations and reports aside, investigators have to confront limits of time and money when completing their studies. So, as in many endeavors, translation is the fly in the ointment and the easy way is to work around it.
When translation is employed in US clinical trials, standards are often low and sometimes even below the professional standards commonly used in other industries. Typically, an Affidavit of Completeness and Accuracy from a “professional translation” agency is all that is required, without consideration of qualifications or the quality assurance process.
This means that anyone who hangs their translation shingle on the web and is willing to sign a letter is effectively qualified to complete the translation. Even if proof of professional qualification is required, such as membership in the American Translators Association, the nuts and bolts of the translation and validation process are often undefined.
Since professional services are often driven by costing requirements to provide one-pass services, using a professional service provider is no guarantee of professional service.
There is also a heavy reliance on interpreters for real-time translation in a “short form” context, without provisions for checking interpreters to ensure accurate understanding by the subjects.
Both of these practices in effect permit the use of single-pass translation. The absence of any quality assurance process dramatically increases the potential for error and misunderstanding. The rate of error for this single-pass approach is very high and consequences can be serious. The checkers must be checked too!
Here at Responsive Translation, “good enough” is not in our vocabulary. We have extensive quality assurance processes to help ensure patient safety and regulatory compliance.
We encourage you to get in touch and discuss your requirements at 1-800-872-6752 (+1-212-355-4455 outside the US) or firstname.lastname@example.org.