Translating for Pharma

What is a translation?

A translation is, essentially, a new document for a new audience, since it is written to reflect the meaning of the source document as faithfully as possible in a new language. This new language could express things in different ways, which will be evident if a professional translates the material back to the original language without seeing the original document (known as back translation).

Translation as teamwork

Translation is always a partnership between all the participants in the process. As the Technical Contact for the ASTM Standard for Translation published in 2014, Helen prepared this work order and uses it to outline clear parameters for all projects or those who request translations (requesters, in this document).

Preliminary questions
  1. Who is the audience? Spanish monolingual speakers, bilingual native speakers of the target language with limited proficiency in the original language, speakers fluent in both languages? Health care professionals, patients, distributors, or regulators? In what country will the translated text be used? Should country-specific terminology be used?
  2. How will the requester handle questions? How long should it take to get an answer? Is it likely the customer will know the answer, or will they have to find someone else in their organization to provide the information?
  3. Is complete delivery when the translation is finalized acceptable? Understand that document 3 on the same topic may shed light on what was not clear in document 1. Partial deliveries complicate communication between translators, editors, project managers, and the requester. They often slow the process down and undermine quality.
  4. What style guide will be used? Does the requester have a style guide, or would they like to receive the one the translation team used to guide their decisions?
  5. Does the requester have a terminology database or previous translations available for reference that should be used for consistency? If the requester has resources, the translator should work with them. Otherwise, it could be important to find out if there are important terminology preferences ahead of time.
  6. How involved does the requester want to be in the translation? Will the translation be evaluated by the requester? If so, having an ongoing conversation with that person through the project can be useful.
  7. Does the requester want a translation of the translated document back into English (a back translation)? Be sure to set realistic expectations. The back translation will always have different wording from the original text while reflecting the same concepts. This is a required step in some fields.
Suggested steps for translation success
  1. Be watchful for ambiguities in the source document. Any discrepancies and contradictions in the source document need to be flagged and brought to the requester’s attention for clarification. Otherwise, the translator may solve these discrepancies in ways that are inconsistent with the requester’s expectations.
  2. Be careful with the use of translation tools. Small differences between one phrase and a similar one can go unnoticed as we accept repetitions in our rush to meet a deadline, especially dealing with sections that do not appear to have technical content. Requesters will check the material that is easiest for them to check: numbers, addresses, names. Step 5 can help mitigate these issues.
  3. Document terminology research. Keep a checklist of terminology issues to watch out for and follow it. Be very careful with terms that might be false cognates or close cognates.
  4. If the document is ultimately intended for use by patients and doctors who speak Spanish, rather than for the regulators who will be approving it, the terms chosen should be terms with which monolingual Spanish speakers are comfortable and will identify. These might not be the same terms used in US government websites. Translators should be prepared to defend linguistic decisions with research and logic. Sometimes requesters ask questions to verify that translators are applying professional best practices.
  5. Be very careful with additions or omissions, even if they are minor clarifications. The review tab of Word has a Read Aloud feature. It can be used to read the translation while following along on the original document to check for accuracy. Anything that might require clarification for the requester can go in the style guide.
  6. At the end, do a search for the terminology issues flagged and recheck all of them. Delaying delivery a little is better than delivering a text with avoidable problems.
How to ask for clarification

“Where it says xxx, on page 1, as a translator I wonder whether you would like it to say yyy or zzz.”

“This text gives two names for the same illness, in the following contexts (list them). What would you like us to do in the translation to maintain consistency with the different names, since one appears to be scientific and the other appears to be colloquial? Here is one suggestion: ________________. The organization appears to have two addresses. Is this correct? Please confirm.”

Problems when there is no flexibility

Sometimes the translator and reviewer are asked to include a particular preferred term and the back translator is asked to make sure a particular English term is used to match that term in the back translation. In those cases, it is important to verify that the English and Spanish terms truly are accurate translations of each other.

There should be some flexibility in translation. The meaning should be there, but the words in the back translation should be expected to be somewhat different than the words in the original document, though they will convey the same message. Translating the English document into a foreign language so that the back translation yields an exactly identical result will produce a document that is rigid and potentially unreadable for the non-English speaking audience and could defeat the purpose of providing language access.

Translation is not about the words. It is about what the words are about.

A flowchart of the translation process
Step Translator Requester
Together, determine:

  • Audience
  • Style guide
  • Terminology resources
  • How to answer questions
  • Deadline for complete delivery
  • Participation of requester in project
  • Need for back translation
Initial decisions:

·         Terminology analysis

·         Decisions regarding tools to use

·         Ambiguities in the source document

·         How to develop a style guide

·         What goes on the checklist?

·         Always keep the intended audience of the translation in mind.

1 Translator delivers the bilingual text in two-column format in a Microsoft Word document.
2 Reviewer edits the translation with track changes on and makes comments. These comments and changes are recorded and approved by the translator.
3 Back translator translates translation back to source language.
4 Back translation comes back. The translator and reviewer verify that the translation approved by the reviewer matches the source text.
5 Specialists from the pharma legal team review the back translation and make comments regarding nuances they found that might be different from their source text. This could include mistakes, negligible linguistic differences that must be explained to the requester, or wording that needs to be translated in a specific way for legal reasons. It may be helpful to ask your requester to flag or categorize changes based on the severity and nature of the change. Does the requester consider it wrong or do they simply prefer that the word be written out rather than expressed in an acronym? Are they changing this for legal reasons, or because they don’t understand why it isn’t identical between the original and back translation?
6 Update style guide
7 The back translator, translator, and reviewer work together to make the requested changes and ensure they are executed in a unified manner across all translation documentation.
8 The new version is submitted to the requester for approval
9 The new version is submitted in two versions: a clean version and a two-column table comparing the back translation and the original text.
10 The requester agrees on the translation
11 The translator certifies the translation with the ATA seal. Both the translator and the reviewer certify the accuracy of the translated document. This should be done at the end, so the requester understands that it is unacceptable to change the document once it is certified. The certification is only valid for the version approved by the certifying translator.
Qualifications ATA certified translators. The ATA certification exam has a 12% pass rate in Spanish.

Subject matter expertise in medical and science topics.

The reader of the document should have verified language proficiency in the language of the document, to avoid the risk of making suggestions that could corrupt the integrity of the translation if implemented.

Review this document on language proficiency of bilingual employees for further information on language proficiency. There are language proficiency tests in reading available through www.languagetesting.com

Sample certification text

I, [translator name], ATA certified translator, certify that:

I performed the translation into Spanish of the document called [document name]

To the best of my knowledge, that translation is an accurate rendition of the original document written in English.

I am a competent translator and have been certified by the American Translators Association as a Spanish to English in [month] of [year] and as an English to Spanish translator in [month] of [year].

Date (Signature) [seals]

Sample analysis of terminology for gradient of severity of adverse drug reactions
Mild or moderate adverse drug reactions do not necessarily mean that people must stop taking a drug, especially if no suitable alternative is available. However, doctors are likely to reevaluate the dose, frequency of use (number of doses a day), and timing of doses (for example, before or after meals; in the morning or at bedtime). Other drugs may be used to control the adverse drug reaction (for example, a stool softener to relieve constipation). Leve

No es necesario ningún tratamiento.

Moderate adverse reactions include:

·         Rashes (especially if they are extensive and persistent)

·         Visual disturbances (especially in people who wear corrective lenses)

·         Muscle tremor

·         Difficulty with urination (a common effect of many drugs in older men)

·         Any perceptible change in mood or mental function

·         Certain changes in blood components, such as a temporary, reversible decrease in the white blood cell count or in blood levels of some substances, such as glucose

Also, reactions that are usually described as mild are considered moderate if the person experiencing them considers them distinctly annoying, distressing, or intolerable

Moderado

Es precisa una modificación del tratamiento (p. ej., modificación de la dosis, adición de otro fármaco), pero la interrupción de la administración del fármaco no es imprescindible; puede ser necesario prolongar la internación o aplicar un tratamiento específico.

Severe adverse drug reactions

Severe reactions include those that may be life threatening (such as liver failure, abnormal heart rhythms, certain types of allergic reactions), that result in persistent or significant disability or hospitalization, and that cause a birth defect. Severe reactions are relatively rare. Doctors use every possible means to control a severe adverse drug reaction.

Grave

La reacción adversa a fármacos pone en peligro la vida del paciente y exige interrumpir la administración del fármaco e aplicar un tratamiento específico.

Lethal adverse drug reactions

 

Lethal reactions are those in which a drug reaction directly or indirectly caused death. These reactions are typically severe reactions that were not detected in time or did not respond to treatment

Mortal

Una reacción adversa a fármacos puede contribuir directa o indirectamente a la muerte del paciente.

Source for this table: English and Spanish Merck Manuals for Home Health. Note this opening sentence from the English article:

There is no universal scale for describing or measuring the severity of an adverse drug reaction. Assessment is largely subjective.

The column on the right was taken from the professional version of the Spanish Merck manual.

In practice, a requester’s document may not match this list. Therefore, translators must do a terminology analysis of the complete list of reactions listed in the document to put the reactions on the gradient list and develop an appropriate terminology list for that document, to avoid confusion.

Resources for translation

Resources not to use

  • US Government websites. The US Government has a policy of contracting the lowest cost technically acceptable bidder, which yields unreliable translation results.
  • Wikipedia is a tertiary source, not a primary source. Researchers are not allowed to quote it as a primary source in research papers. It is a great place to get a basic idea and then keep researching.
  • Linguee. This is basically a quick check of how something has been translated in various contexts. It can yield unreliable results.

Resources to use

  • The Merck Manual, which is available online in many languages in two versions: for professionals and for patients. These versions are not direct translations of each other in the different languages. They are carefully written and edited in each language to be used as a direct resource for people in those language cultures. These resources have been discussed with members of the American Medical Writers Association in charge of writing medical documents in Spanish, and one (an Argentine MD who has been a translator and is now in charge of the medical documentation for an organization like this pharma group) says there is no better resource than the Merck.
  • Word Magic, an app available for the iPhone and iPad. Its translations do not just come, as many do, as a bilingual glossary, but also with synonyms, sentences, and other useful information for context. The medical, business, legal, slang, and general versions are constantly updated.
  • The Jablonsky dictionary of acronyms and abbreviations.
  • Vox Médico.
  • Other specialized resources written for medical professionals.
  • Diario Médico, a newsletter for doctors from Spain.

Style guides

Regarding style guides, although the Real Academia Española is highly regarded, Deusto has published a style guide that is an adaptation of the Chicago Manual of Style in Spanish: Manual de estilo Chicago Deusto, edición adaptada al español. This is used by many translators who work in technical fields and is consistent with the 2010 updates of the Real Academia Española.

This is a highly regarded resource, which we use as a primary resource in most translations. It provides helpful references for the editor at all stages of the editing process in one volume, which makes it particularly useful.

One reason for using the Deusto is that there are several RAE publications, making it difficult to follow the thread of what guidelines have been followed in each of the many publications that RAE has published on the same topic in the last few years. However, El buen uso del español is one of the most practical ones and is available on Kindle. On the other hand, it often seems to contradict some of the guidelines in the larger references, such as the Nueva Gramática and the Ortografía. As translators, we make decisions regarding style based on the document and the needs of the requester. Editors develop style guides for each setting, and so do we.

Image source: Pixabay

Author bios

by Helen Eby and Carlie Sitzman

Carlie Sitzman graduated from Weber State University with a BA in German and an AAS in Technical Drafting in 2009, at which time it was clear that best way to make her passion for language and fascination with technology into a career was to become a translator. In 2011 she moved to Germany where she simultaneously freelanced and earned her MA in Intercultural German Studies from the Universität Bayreuth. She now translates from offices in Wilmington, Delaware and will be celebrating her ten-year anniversary in the industry this year. www.sitzmanaetranslations.com