Validation For Clinical Trial Translation - Goldilocks Analysis (Part 3 of 5)

Part 3: This Porridge is too Cold.quality assurance process.
In Part 1 of this post, we dumped on clinical trialThis means that anyone who hangs their translation
translation in general, and in Part 2 we dumped onshingle on the web and is willing to sign a letter is
the gold standard of clinical trial translation. But I ain'teffectively qualified to complete the translation. Even
done yet. Today we'll dump on everyone else.if proof of professional qualification is required, such
Whatever Goldilocks may say, unrealistically highas a membership in the American Translators
MAPI standards are less of a problem then theAssociation, the nuts and bolts of the translation and
general lack of professional translation standardsvalidation process are often undefined.
often employed in the clinical trial process.Since professional services are often driven by
In most stateside trials, translation is notable for itscosting requirements to provide one-pass services,
absence. Those who don't understand English areusing a professional service provider is no guarantee
generally excluded from studies. Unfortunate, butof professional service.
understandable too. Declarations and reports aside,There is also a heavy reliance on interpreters for
investigators have to confront limits of time andreal-time translation in a "short form" context,
money when completing their studies. So, as in manywithout provision for check interpreters to insure
endeavors, translation is the fly in the ointment andaccurate understanding by the subjects.
the easy way is to do work around it.Both of these practices in effect permit the use of
When translation is employed in North Americansingle-pass translation. The absence of any quality
clinical trials, standards are often low and sometimesassurance process dramatically increases the potential
even below the professional standards commonlyfor error and misunderstanding. The rate of error for
used in other industries. I've always found thisthis single-pass approach is very high and
surprising, considering the importance of goodconsequences can be serious. Checkers must be
translation to patient well-being, in such a closelychecked too.
supervised and regulated space.Goldilocks' Analysis: This porridge is too cold. Any war
Typically, an Affidavit of Completeness and Accuracystories out there? Did I get this right?
from a "professional translation" agency is all that isNext, Part 4...
required, without consideration of qualification or