The documents we create for clinical trials are collections of words. Reviewing these documents can be a straightforward process, with the final draft approved after one or two rounds of changes. In clinical trial translation management, sometimes a document is improved by the edits, sometimes not. However, did you ever have a time when the editing process felt like an uphill, labor-intensive, emotionally-draining climb that might never end? Did it feel worse with translated documents? If the answer is yes, you are not alone.
Language and emotion
Language is the dominant way we human beings form a connection. We use language (written, spoken, or signed) to express our feelings, share our thoughts, convey concepts, and inspire others to see from our perspective. Connecting through language is not flawless, and feeling misunderstood or unheard is often a strong demoralizing experience. It makes sense that feelings can run high when words are concerned.
We’ve all had an email message rub us the wrong way. It takes a sophisticated level of self-awareness to understand exactly why. Usually, we just feel annoyed at how inconsiderate, unprofessional, or ignorant the email’s author is. Reviewing documents elicits a similar response. Good or bad, it’s normal for each of us to have opinions on how we would prefer to word a statement. These preferences drive word choices, the number of words used, and the order of words, resulting in hundreds of ways to make essentially the same statement. The optimal balance between direct and polite can vary widely based on the individual’s personal and cultural background.
In a translated document, the emotions are amplified. The reviewer is essentially reviewing the content from both the source and target language documents. It can be more challenging to tell which one the reviewer is trying to update when all of the edit requests and commentary are made exclusively about the translation.
Tips to improve clinical trial translation management outcomes
What can we do? Although there still isn’t a cure for being human (a bummer, I know!), we can set the stage to incentivize better outcomes. These three tips can help:
1. Make the source content visible early
Providing visibility to the source content early in the project is ideal. This way, you’ll also gain insight into issues being introduced by the source content. For example, there may be a mistake in a visit schedule or a section that only applies to a few countries. The team will be able to address content issues directly. Mistakes can be corrected or a different version of the source document can be created for specific regions. The issues will also be addressed earlier before project delays add stress to everyone involved.
2. Set review expectations
Providing clear instructions also helps narrow a reviewer’s focus. The phrase “please review” leaves it open for the reviewer to decide what they will be looking for. If you have several reviewers, they may all look for different things, creating inconsistencies among the document versions. If a reviewer splits their review over several days, s/he could feel differently on each day and rework documents several times and introduce inconsistencies.
Be specific about what you are asking reviewers to look for. For example, “Please only review for compliance with local regulations regarding payment schedules. Do not make any other changes.” Setting clear expectations can help reduce unnecessary time on the reviewer’s part and reduce communication rounds between your team members and reviewers.
3. Establish consequences for not meeting expectations
Communicate an escalation path that will be used if things go south. Here are some potential issues that should be addressed upfront:
- When reviewers are late, who documents this? Who is notified?
- Are there on-time/late reports, and if so, when do they go out?
- When reviewers make changes they were told not to, what happens? Are they asked to complete a lengthy form?
This is not meant to be punitive; it is meant to create a path of least resistance in the direction of ideal project outcomes. Providing a project environment of healthy group accountability has many beneficial outcomes, including time and labor efficiencies.
With basic project planning and adherence to the agreed-upon process, document review in any language can be a positive collaboration among teammates.
Click here for another interesting blog about the translation of clinical trial materials.
Do you have clinical trial translation management best practice examples to add? Horror stories? Please let us know in the comment box below.
Updated: 28 July 2022