Protocol amendment translation is a challenging but key service in the life sciences translation field. Amendments are changes or modifications made to documents, specifically, clinical protocols in this case. They are typically made to update, clarify, or revise existing protocols in order to adapt to changing scientific, technological, ethical, or regulatory considerations. Consistency in amendments is of utmost importance to ensure that the original documents remain coherent and effective.
In this blog, we will take into consideration some tips and guidelines when it comes to amendment translation.
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Life Sciences Translation 101: Protocol Amendment Translation
Something worth mentioning is that protocol amendments are eminently scientific documents and are intended for a wide range of readers, from the most specialized to ordinary people, therefore, they must be clearly written. And this applies to the translation as well.
The scientific translation must be very accurate from a grammatical point of view. Otherwise, the reader may not get the right information. It is necessary for the translation to adhere to the original document, and avoid attempts to express the same idea in the translator’s or editor’s own words, as this is not always correct.
How to guarantee consistency in protocol amendment translation?
When translating or editing amendments to a protocol, one of the most important aspects is the uniformity and consistency of the terminology used. Since amendments usually come in monolingual files, we do not have the possibility to use Xbench or any other CAT tool to help us check for consistency. Therefore, it is essential to check the file we are updating, to make sure that we are using the same terminology and that the references made to different parts of the amendment actually match what we are translating.
A very common mistake, especially when translating or editing the summary of changes (SOC) of the amendments, is to translate the names of the sections without taking into account how they were translated in the original protocol. This results in mentioning a section that later cannot be found in the original document. The same happens when the change made in the amendment is the deletion of text that is cited in the summary of changes.
Let’s look at one example. If the explanation of the summary of changes reads: “The expression ‘qualified subjects’ was changed to ‘eligible subjects’ in Section 8.1.2”, what should be done is go to section 8.1.2 in the translation of the original protocol and look at how ‘qualified subjects’ was originally translated. In doing so, we make sure that the same translation is used in the clarification of the amendment.
Pro-tips to protocol amendment translation
1. Working with track changes
When translating or editing amendments, it is crucial to have a system in place to manage the changes we make. This includes keeping track of all modifications made to the original document, using revision marks, and maintaining consistency in formatting and style.
2. Checking footnotes and version dates
Footnotes in medical documents often contain important information that may need to be updated in amendments. It is essential to carefully review footnotes and make the necessary updates, including version dates, to ensure that the information is current and accurate.
3. Handling summary of changes
The summary of changes (SOC) section in amendments is an important part of medical translation. It is important to translate the names of sections referenced in the SOC accurately, using the same translation as in the original document. Additionally, when text modifications are mentioned in the SOC section, it is necessary to search for and use the same translation of the original text in the amendment to maintain coherence in the document.
4. Translating specific terminology
Medical protocols often contain specific terminology that may require careful translation. It is essential to search for and use consistent translations of terminology used in the original document when translating amendments.
5. Verifying page numbers and updating tables of content
Page numbers and tables of content may need to be updated in amendments to reflect the changes made. It is crucial to carefully review all page numbers and titles in the document to ensure that they are correct and update them accordingly. This includes checking for section breaks or page breaks that may affect the formatting of footnotes and tables of content.
Don’t let inconsistent protocol amendment translations compromise the success of your research project. Follow these tips to ensure accuracy and coherence in your translation work: use track changes, check footnotes and version dates, handle the summary of changes accurately, translate specific terminology with care, and verify page numbers and update tables of content. Contact us to discuss your life sciences translation needs and learn how we can help ensure your translation project is a success.
At Win & Winnow, we understand the linguistic needs of the life sciences industry. We have almost 20 years working in the industry and have developed specialized workflows. If you need to translate amendments, contact us today for a free evaluation and quote.
