Clinical trial translation into European Portuguese
Clinical trial documents have very different readers: the ethics committee, the investigator, the participant. An informed consent form must be accurate and, at the same time, clear to a lay reader; an agreement must use Portuguese legal language.
I translate and review these documents into European Portuguese, with the terminology, register and forms of address that participants and ethics committees in Portugal expect.
What it covers
- Informed consent forms (ICFs), addenda and paediatric assent forms, in age-appropriate language
- Protocols, synopses and amendments
- Clinical trial agreements (CTAs) and budgets
- Participant materials: cards, diaries, recruitment leaflets, letters
- Investigator letters and supporting submission documents
Frequently asked questions
- Which term do you use for the person in the study: participante, doente or paciente?
- “Participante”, which describes the person’s role in the study and covers healthy volunteers and caregivers. I use “doente” when the text refers to the disease or standard care. “Paciente” is uncommon in clinical documentation in Portugal and is often a sign of a translation made for Brazil.
- Can you review an informed consent form that has already been translated?
- Yes. I review the whole file against the source, segment by segment, and flag meaning errors, terminology, readability issues and Brazilian Portuguese markers.
- How do you keep versions of the same study consistent?
- I work from the memories, glossaries and previously approved documents the client provides. For an amendment, I start from the approved version and change only what the source has changed.
Other fields
For a quote, please include the document type, language pair, approximate volume and deadline. If possible, attach the file or an excerpt.