For medical translators experienced in European regulatory submissions, QRD templates are an important tool of their trade. Even if you are not regularly involved in these kinds of projects, these "Quality Review of Documents" templates are a good resource.
QRD templates are a set of documents whose main objective is to set out standard phrasing, terminology, and stylistic preferences for product information (Summary of Product Characteristics, package leaflets, labeling) as well as to provide guidance on layout. These documents are currently available in 24 languages (22 EU languages plus Icelandic and Norwegian).
Working with these templates isn't always clear-cut though. Some of the recommended headings and phrases lead to questions during readability tests.
Here are some sample challenges that we've encountered:
1) Grammatical errors
Maltese in QRD template: Kontra-indikazzjonijiet
Correct Maltese: kontraindikazzjonijiet (the latest decisions on Maltese spelling/grammar is available from the Maltese Language Council [PDF link])
2) Inconsistencies between text in product information and the templates
English in template: Product Information Leaflet
English in product information to translate: Product Leaflet
3) Incorrect terminology
English: European Medicines Agency
French in QRD template: Agence Européenne du Médicament
Correct French: Agence européenne des medicaments (this is according to the Interinstitutional Style Guide, which, interestingly enough, gets recommended by EMA itself)
4) Typos introduced by QRD members after their review of the translation
So, what is a medical translation professional to do? Follow Golden Rule #1: Be honest. If you see an error or discrepancy, report it.
Sounds obvious but a lot of translators assume that the QRD templates are "non-negotiable". This is not the case. Linguists would never replicate errors in any other kind of translation project, so why do so in the case of QRD templates?
Firstly, sometimes inconsistencies may arise between product information in the templates and the files received for translation, like example 2 above. Perhaps in this example, it stems from an oversight on the source technical writer's part. But this could also be because, in the words of the EMA, the templates "are by no means a comprehensive guide to the information required to be included in the product information". Each company will draw up their product information based primarily on the template but there may be amendments to adapt the information to the product. Depending on the product, information could be added or omitted.
The best thing to do is to speak up and seek guidance from the client. If you don't report the discrepancies, more likely than not, your client will come back to you questioning why your translation differs from the QRD template.
Secondly, the QRD Working Group aims to provide guidance to the EMA on linguistic aspects relating to product information. Their objective, like ours as linguists, is quality and readability. For this reason, the QRD template has gone through various rounds of consultation and opinion from patients, pharma professionals, etc.
But this doesn't mean that some errors have not slipped through the net. Obvious errors such as typos should be brought up to your client, justified, and rejected in favor of correct spelling, terminology, and grammar. It is important that any errors are brought to light. Proactive consultation with the client and, if necessary, QRD members will save overall time and improve the usability of translations.
And finally, the QRD template is in the process of getting a face lift. A couple of weeks ago marked the "end of consultation deadline" for comments on the QRD template. Does that mean, speak now or forever hold your peace? Not quite.
This day may have signaled the deadline for comments on the QRD template, but that doesn't mean we should accept everything at face value, and cease in our endeavor to continually improve the quality of our regulatory submission translations.
Remember the Golden Rule, and you won't go wrong.
[Thanks, Anabel, for the content!]
ForeignExchange Translations provides specialized medical translations for electronic as well as paper-based regulatory submissions. Contact us to find out more.
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