Evaluating Processes and Benefits
Tina Wuelfing Cargile, PMP, Business Development Manager – Life Sciences Division
Just today, a prospective client approached me with the question: is the back-translation process the recommended method to ensure quality? The answer, as is so often the case, is—it depends.
It is important to examine the translation process as a whole to arrive at the best answer for your project, starting with the QA steps undertaken during the forward-translation phase.
• Into-Foreign-Language Translation: Best Practices
The utility of the back translation is historically linked to the steps involved in the original translation into a foreign language. The practice of using a single, independent translator to perform this task makes this step useful, if not imperative.
It is a well-known tenet of our industry that an individual should not proofread nor edit his or her own work, and the old saw that “two heads are better than one” rings true, as it always has. One of our senior technical editors recently likened our iterative translation QA process to the practice of multiple rinsings of glassware by a bench chemist—each step of that process refines the purity and decontamination of the vessel.
The preferred QA process for the forward-translation step should include translation by a linguist qualified not only as a translator, but qualified in the specific subject matter at hand. A second, equally qualified translator should serve as an editor, and the subsequent, collaborative version should be reconciled to resolve any disagreements regarding terminology and meaning.
This can be considered the first “rinse.” It is still critical to have yet another set of eyes check for omissions, numerical errors in dosages, etc. An additional step of final QA must include yet another look by yet another person, to ensure that nothing was overlooked. These steps would constitute the second and third rinse.
At this stage, the QA process has usually resolved any meaningful issues, and a back translation will generally reveal only slight stylistic issues.
However, if a back translation is still desired, the process involved in that stage also bears examination.
• Back Translation: Best Practices
Performance of a back translation is only as useful as the output. Delivery of a document that raises questions and concerns for the requester only adds to his or her workload and doesn’t resolve any variances nor verify the quality of the original translation.
Recognizing this fact, we revised our back-translation process some years ago, to include a reconciliation of the results. What does that mean?
Following the back translation—(which includes input from a similar, but new, two-translator team)—the original English source document is compared to the back translation, and any possible discrepancies are noted.
This process is followed by an investigation as to whether the noted discrepancies are due to issues with the forward translation or with the back translation.
Another element of this process is reserving delivery of the forward translation until the reconciliation step has been completed. This avoids issuing a document that may require revision. Generally the process can be completed in the same time frame as a single, forward translation, but this presents a distinct issue that bears discussion.
• Are You Putting the Quality of Your Project at Risk by Requiring a Back Translation?
In order to meet required deadlines, the process can certainly be compressed to accommodate both the forward and back translation. Considering a large project with a tight, nonnegotiable turn (let’s say you have patients available for a study, but only within a limited time frame), you may be adding to the risk of less than ideal quality by rushing the first step to allow for the second.
Translation is a handcrafted, deliberative process, and it does take time. Shortchanging the into-foreign process can mean that the back-translation step is applied like a Band-Aid on a massive wound. Most reputable translation vendors will not agree to a turnaround that will jeopardize your results, but the potential always exists. Your best protection is to thoroughly understand all of the QA steps that will be applied to your project and make a decision based on the situation.
• Other considerations
Implementing an in-country or colleague review can be an excellent alternative or add-on to the translation process, whether or not a back translation is performed. A reputable and responsive translation partner should encourage this step, when it is feasible. The input of those "on the ground" working on your clinical trial is invaluable because their suggestions and preferences regarding terminology and style are impacted by their interaction with the human subjects involved in the study. Such preferences can be preserved in glossaries and translation memories, resulting in quality and study-targeted improvements over time.
Finally, talk to your translation vendor about process. Often we see back-translation orders that are intended to validate forward translations done by another vendor or by another source. While the intent is clearly to maintain objectivity and clarity of process, this practice dilutes the advantage of having a single project manager and a well-designed team carrying your project forward, and can bring financial and timeline costs as well.
Bottom line—translation services are likely not the most pressing line item in your budget, but take the time to understand the processes and services they represent. The differences may surprise you and save you much more than money—-the validity of your study, the quality of patient protection, and your time.