When an English source requires a revision after translations have begun, this can be a major challenge in maintaining set budgets and timelines in global COA clinical trials. Often, these revisions seem minor but can end up having a significant impact on the multiple languages in scope for a study. An often-overlooked aspect of source revisions is that in addition to increasing timelines and costs, they also add inherent risk to the quality of the translations. While source revisions cannot be completely avoided, there are ways to prevent many of them that will greatly increase the probability of a successful launch.

What is the Risk?

How and why does quality risk get introduced into the translation process when a source is revised? There are generally two ways that a source revision can be processed by the translation vendor:

1. 1. By transferring all ongoing content from one format to another format
2. 2. By manually updating the existing content after it is finalized in its existing format

The choice of method is dependent on the nature of the revision and the timing of when it is submitted. In the first instance, the transfer of content causes language to be reprocessed and, in some cases, unintentionally altered. In the second instance, the content updates must be performed by a human, thus removing the ability to utilize built-in technology checks that act as quality safeguards. While additional QC checks can and should be added into the process by the translation vendor to mitigate such risk, these checks are also performed by humans and have limits. Additionally, a source revision often leads to an expedited timeline, causing increased pressure on those QC checks that are being performed in a hurried manner. The best method of preventing the risk inherent to source revisions is prevention of the source revision to begin with.

Source Revision Prevention

Below are four ways to prevent source revisions in COAs:

1. Identify your review team to get prior sign-off

If a reviewer has not been included in the original source creation or formatting but is then added at a later stage, this will likely lead to source revisions. This is because all reviewers tend to make changes. All necessary stakeholders should be consulted so that all source reviewers have final sign-off prior to beginning translations. 

2. Ensure the eCOA source is final and accurate

It is important here to focus on both aspects of risk—that the source is final and accurate. Quite often, one of these aspects is taken for granted. 

Finalize your eCOA build:

The eCOA source build may require multiple rounds of review and User Acceptance Testing (UAT) before it is finalized. The timelines for these steps must be accounted for in initial planning to ensure that the eCOA build is not being reviewed while translations have already started. All UAT testing should be complete and sponsor sign-off should be in place prior to beginning translations. 

Confirm accuracy with technology:

Additionally, the accuracy of the eCOA build is imperative. Ensuring the QC on the eCOA source prior to beginning translations will reduce timelines, costs, and errors in the future. Your eCOA vendor may not have technology processes in place to provide an exportable report ensuring equivalence with the validated paper version in order to prevent unwarranted deviations. However, your translation vendor should be able to assist in providing a source review that captures deviations from the paper version for final sponsor sign-off in an exportable report.

3. Manage the timing and communicate with your translation vendor

As mentioned before, some source revisions are unavoidable. However, it may be possible to control their timing. Source revisions received at a certain point in the translation process may have more risk and/or more effect on timeline and budget than those received at a different point in the translation process. A source revision that arrives during or after cognitive debriefing may require additional debriefing, which will significantly increase the cost and timeline. Alternatively, a source revision that arrives while the files are being prepared by the translation vendor could come with slightly increased timelines and very low risk. For example, if an eCOA vendor identifies that a functional update is needed, this should be escalated to the translation vendor as soon as it is identified, not at the time when the functional update is complete and ready. The translation vendor may be able to proactively mitigate risk by putting certain steps on hold or creating a plan in conjunction with the eCOA vendor. It is critical to openly communicate with your translation vendor as soon as a source revision is anticipated. This should be done no matter what the nature of the source revision is, even if it is formatting or functional and will not affect language. 

4. Know the risks 

A source revision may not always be necessary or worth the trade-off. It is important to understand the specific risks associated with each source revision to make an informed decision. Your translation vendor should be able to provide you with a clear list of risks associated with a source revision and the different impacts depending on when they are submitted. These risks, together with their likelihood of occurrence, can be used to make an informed decision about the source revision and how best to manage it. 

While source revisions are often necessary for a successful study launch, they can also lead to increased costs, timelines, and quality risks in the context of COA translations for global clinical trials. Furthermore, they can often be avoided and quality risks can be reduced by preventing the revision to begin with. Contact us at COAsolutions@transperfect.com for more information on risk mitigation and other COA/eCOA-related information