With so many clinical trials now using COAs on electronic platforms, the practice of “migration” (transferring and adapting COAs for electronic use) has become more common than ever. Without careful implementation, one minor deviation can compound across many languages, leading to delays in FPFV or, if not caught prior to deployment, data integrity issues.
If these types of issues are discovered and corrected before the translation process begins, it can prevent the need for a COA source update during translation, saving your budget and timelines in upcoming global clinical trials.
Possible Migration Issues
The time to begin paying attention to eCOA migration is during the very start of project planning with your eCOA vendor. Here are some common errors that may arise if the migration is not prepared fully and thoroughly:
1) Paper to electronic adaptations
When using a COA designed for use with a pen and paper, it is not always as easy as replicating the questionnaire in full and using it on the eCOA device.
Many COAs use terminology and context that is not applicable to electronic devices.
For example, an iteration of the instruction “circle the answer that corresponds…” is commonly changed to “select the answer…” or “tap the answer…” This may seem obvious, but if it is not adapted during the first design phases with your eCOA vendor, it may require additional work to fix later on.
Other less obvious examples of such adaptations could be references to “pages” versus “screens.” A paper questionnaire might have 20 questions on one sheet, but once it is adapted for use on a tablet or smaller handheld device, the instruction to “answer each question below” might not make sense if there are no questions below that text on the screen.
It is imperative to consider and address these types of changes early on, before the error is replicated across every language in the trial.
Your language service provider (LSP) should be equipped to ensure that these adaptations are made consistently across all languages in the trial to ensure data integrity.
2) Accidental source adaptations
Sometimes, a minor typo or error in the eCOA build might create what appears to be an intentional adaptation to a COA for electronic use. It could be as minor as a change in a preposition, or as obvious as a grammatical mistake. Sometimes, it can even change the meaning of a sentence. If the translation vendor accounts for all electronic adaptations, this error could be replicated globally.
It is best practice to document and review all adaptations made to COAs during migration in order to verify the validity of a change. Your LSP should also be able to easily recognize all adaptations made to a COA before translating. They should verify correctness before perpetuating an error that could cost you time, money, and integrity in the trial data.
3) Copyright holder permissions for electronic use
There are many COAs in the public domain, but a significant amount are also copyrighted and used only with permission.
You should always ensure that the permissions to use such COAs apply to electronic versions as well.
Additionally, many copyright holders already have electronic-specific versions to be used, which minimizes or eliminates the need for job-specific adaptations. They may have two different validated versions, one for use on paper and one for use on electronic devices.
Always check to ensure you have the electronic version of a COA and the proper permission to use it for your intended purposes.
4) Reference file errors and how to address
Mistakes can happen—even in existing validated COAs that have been in use for years. There can be minor grammatical errors or, in rare cases, mistranslations.
Some COAs have been around longer than modern language rules, resulting in outdated (but usually understandable) terminology, spelling, or grammatical rules.
Even English COAs can have mistakes. Whether the errors are found in the English source or target languages, the process to address them is the same. Make sure your LSP has SOPs in place for handling errors detected in reference files. They should determine the severity of the error, and, most importantly, if it could impact the patient’s understanding of the meaning.
If a change is needed, ensure that permission is granted by the copyright holder (if applicable) to make the necessary updates. If the error is in the English source, it is best to eliminate any ambiguity in meaning before it is translated and interpreted differently in various languages.
5) Repeated segment errors and variable text
On the more technical side, there is great significance in how the electronic file is formatted or coded that can prevent an eCOA migration from being implemented correctly. If the electronic format is not coded in a way that can adapt to various language rules, it can result in the questionnaire being recoded to accommodate the translations, which in turn can lead to significant increases in costs and timelines if not corrected early.
If an English source COA has 20 questions with a range of responses, such as “mild,” “moderate,” and “severe,” perhaps those terms are the same across the entire questionnaire in English. However, that doesn’t mean the translations are also the same throughout.
Other languages may have different responses for each question that depend on grammatical intricacies of the language in question, such as gender agreement, case, or the context of the question.
A tempting shortcut is to format the eCOA using variable text in such a way that these words only appear one time each instead of 20 separate instances.
However, this means that translations that use different terms don’t have a separate place in the software to insert the correct translation. The only way to fix this is to rewrite the coding in the electronic file, which often has catastrophic results for timelines. This problem is not limited to just question responses, but also headings and instructions. It should not be taken for granted that because an English word or phrase is used throughout the COA that the same will apply to all languages.
Work with your eCOA and LSP to ensure the eCOA file is built to handle the varying rules of translations.
Alleviate the Issues with LSPs
While these migration issues mentioned above can cause significant problems, you can partner with eCOA providers and LSPs to prevent issues with your trials. It all starts with putting in place a proper source quality assurance process, preferably assisted by the latest migration technology innovations.
In addition to being experts in the accurate migration of translated text, TransPerfect partners with sponsors and eCOA vendors to ensure best practices are followed from the beginning of the eCOA build process through final submission.
Contact us at COAsolutions@transperfect.com for more information and details about migration process solutions.