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QRD templates are imperfect, getting better

QRD templates are imperfect, getting betterFor 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
English: Contraindications
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.


  1. cgtradmed said...
    I fully agree with you. I have always done what you recommend. It is why my translations are often punctuated with "comments" and requests for checking such or such item.
    Then the client's reactions are as follows :
    1) Some agencies reply : "we asked you to translate, final dot. We don't need all this." and do not even forward the remarks to the final client.
    2) Some agencies are suprised and need to be pushed to gather their courage and forward the remarks to the final client, who appreciates generally
    3) Some agencies are grateful to me and forward the remarks without any hesitation to the final client, who appreciates most of the time.
    I do work with the latter, not with the first ones and rarely with the second category.
    But, I must admit that it took some long years before agencies/clients eventually accept my approach to work, and also long years before I accept to lose clients of the first category (mentioned above) and I dare to impose my way of working.
    I think it is difficult for a young translator to feel at ease in this kind of circumstances.
    medical school said...
    this is a very typical topic & you explained it very ease that i liked.
    amaxson said...
    @ cgtramed: Thank you for the feedback!
    We appreciate hearing from linguists, and like we said, honesty is key. Sometimes it is difficult to communicate discrepancies with clients, but the linguist should not feel that. The linguist's job is to point out to agencies anything that is incorrect or that he or she does not agree with. It is the agency's job to work out potential problems in the QRD with the client.
    We can appreciate a young translator may feel uncomfortable pointing out potential issues, but hope that the agency can foster a relationship of trust and open communication with the linguist.
    Pashto Linguist said...
    Something I did not think about involving linguists. What an interesting yet challenging career.
    Greek Translator | Μετάφραση said...
    Very interesting post. I think a lot of translator have come across this issue. Templates shouldn't be viewed as "sacred". Mistakes are everywhere and we have to keep our eyes open to spot them.
    Claudio Porcellana said...
    I fully agree

    as explained in my last Linkedin Medical Translators and Editors post, and in particular under "The moral of the story"

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