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In clinical trials, Clinical Outcome Assessments provide the necessary data to assess patients and their conditions. Nowadays, such assessments are performed more and more in electronic platforms, so any paper versions of the questionnaires, also known as paper scales or instruments, need to be migrated in an electronic format. But what are the challenges involved in this eCOA migration process?
1. Source text updates (paper to electronic version adaptations)
Any company providing eCOA solutions is very aware that, even though the core of the questionnaires being handled remains the same, the source text and its translation should be adapted accordingly to cater for the differences in format. A quite common example is that the paper version of an instrument may read “Please circle what applies”, whereas this would not be possible in an electronic format. Such points should be considered when designing the electronic version of the instrument, for the migration to be successful. So, in the case of the example above, the source text and, by extension the respective translations, should be adapted to something like “Please select what applies” or “Please tick any checkbox that applies”.
2. Repeated content that needs to be differentiated in the translations
On another note, within the framework of translation projects, it has been repeatedly observed that what may be suitable for one language may not be applicable to another, due to objective factors, such as grammar and syntax. The same goes for eCOA migration and, especially the repetitive content, such as the possible answers. To be more specific, let us take the scenario of multiple questions having the same possible answers, such as “Normal”, “Mild”, “Moderate” or “Severe”. All four options above shall remain the same for all questions in English. However, in other languages, where there are differences due to grammar and syntax, these options may need to be differentiated based on the context. Therefore, the linguists migrating the content need to be offered with the option to differentiate repetitive content based on the context and any locale‑specific rules.
3. Repeated content translated differently in the copyrighted instruments
Contrary to the previous example, there are cases where the repeated content does not objectively need to be differentiated. Nevertheless, given that many of the translated instruments that need to be migrated may be copyrighted and thus the linguists need to strictly follow them, it is important to make sure that any inconsistencies in renderings of the same content are kept during the migration process as well. Of course, this should happen if any such inconsistencies do not create any confusion to the end users of the instruments. If they are indeed problematic, then the copyright holder should be notified the soonest possible, so that a correction may be approved and implemented in the content to be migrated.
4. Content adapted for cultural appropriateness
Another important aspect to take into consideration during the migration process is not to miss aspects that may have been localized due to cultural appropriateness. To give an example, during migration, it is important to pay attention to details such as whether a certain country has a “President” or a “Prime Minister”. Therefore, it is crucial that the relevant questions are correctly formulated for the patients in the respective countries. Another example could be addresses or lists of items, which the patient may need to recall or enumerate. In such cases, it is highly likely that the source text may have been culturally adapted in the target instruments, so that the patients are asked questions that may be equivalent and easier to grasp in the respective target language. In such cases, it is important to pay attention to any non-literal translations that may exist in the target reference instruments and keep them the same way in the eCOA migration too.
5. Instruments containing errors
Whereas in the instances described above any non-literal translations are intentional and need to also be respected during their migration, there are cases where the approved and copyrighted translations may contain typos or, other, more significant errors. On such occasions, the linguists should take the time and report any issues identified, so that the copyright holder gets notified and approves any necessary deviations from the copyrighted content.
6. In-context review
Last but not least, in order to have the migration process completed, it is always very important to perform a last linguistic review of the migrated content for each target language within the environment where the patients’ assessments will be taking place. However, giving linguists access to the actual platform may be challenging. What is more, the alternative of creating screen reports, where all screens for a specific study are exported for in‑context review may be time‑consuming, but this last step does help guarantee the quality of the migrated content and thus is of vital importance.
To sum up, eCOA migration may be a complicated process entailing multiple steps and stakeholders, but it enables the collection of data almost in real time, without having to decipher difficult handwritings or aggregate data manually.
If you want to collaborate with an experienced team in eCOA migration projects, contact Commit Global, and your results will be guaranteed.