Login or register (free and only takes a few minutes) to participate in this question.
You will also have access to many other tools and opportunities designed for those who have language-related jobs (or are passionate about them). Participation is free and the site has a strict confidentiality policy.
20:47 Sep 1, 2008
English to Portuguese translations [PRO] Medical - Medical (general)
English term or phrase:Investigator's brochure
Olá. Alguém sabe me dizer o equivalente deste termo em português. A definição em inglês é essa:
"The Investigator's Brochure (IB) is a basic document which is required in a clinical trial of a new drug (that is, one not yet approved by regulatory authorities for sale), together with the clinical trial protocol. The IB contains both clinical and non-clinical data pertaining to the new drug. The pharmaceutical company sponsoring the study provides a copy to each principal investigator (local researcher) prior to the start of a clinical trial."
Esse termo aparece no final de um arquivo PowerPoint relativo ao um medicamento, ou seja fala do "Investigator's brochure do remédio X" que seria um material de referência.
Ainda não localizei um equivalente e gostaria de utilizar o termo "oficial" para esses casos. Agradeço qualquer ajuda.