Investigator's brochure

Portuguese translation: brochura do pesquisador

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.

Renato Camargo KudoZ activity Questions: 230 (1 open) (4 without valid answers) (3 closed without grading) Answers: 10
Local time: 01:03

Portuguese translation:brochura do pesquisador

Explanation:
:) Pode parecer estranho, mas é isso

Selected response from:

Clauwolf
Local time: 01:03

Grading comment

Obrigado Clauwolf, foi isso que utilizei e obrigado a todos pelas sugestões.
4 KudoZ points were awarded for this answer

Summary of answers provided

4 +6

brochura do investigador

Cris RiJoFe

5 +4

brochura do pesquisador

Clauwolf

manual do investigador

Mariana Moreira

brochura para o investigador

Maria Teresa Borges de Almeida

caderno de pesquisa (protocolo)

Flavia Martins dos Santos

manual do pesquisador

Roberto Cavalcanti

Answers

10 mins confidence:

peer agreement (net): +4

investigator's brochure

brochura do pesquisador

Explanation:
:) Pode parecer estranho, mas é isso

Clauwolf
Local time: 01:03
Works in field
Native speaker of:

Portuguese
PRO pts in category: 550

Grading comment

Obrigado Clauwolf, foi isso que utilizei e obrigado a todos pelas sugestões.

16 mins confidence:

peer agreement (net): +6

investigator's brochure brochura do investigador

Explanation:
De acordo com o Diário da República - I Série A - N.º 195 de 19 de Agosto de 2004, a «brochura do investigador» refere-se à «compilação dos dados clínicos e não clínicos relativos aos(s) medicamento(s) experimental(ais) pertinentes para o estudo desse ou desses medicamentos no ser humano».
O Infarmed recorre igualmente a essa expressão.

Reference: http://www.lexmedicinae.org/por/ENSAIOS%20CLINICOS.pdf

Cris RiJoFe
Portugal
Local time: 05:03
Specializes in field
Native speaker of:

French,

Portuguese
PRO pts in category: 8

26 mins confidence:

investigator's brochure manual do investigador

Explanation:
É como normalmente os meus clientes preferem:

O Manual do Investigador, disponível para download, é direcionado a todos os ... A leitura do Manual do Investigador irá responder aos temas abordados pelo ...
www.ibpcancer.org.br/investigador.asp -

Manual do investigador para a erradicação da transmissão da Poliomielite no Brasil. Brasília: 1988. ______. Manual de normas para o controle da tuberculose. ...
www.drashirleydecampos.com.br/noticias/999

Elaboração simultânea do manual do investigador com esclarecimentos acerca dos dados a recolher e da metodologia a utilizar e com menção da bibliografia ...
newdbserver.med.up.pt/web.care/reunir/material.html

Mariana Moreira
Portugal
Local time: 05:03
Specializes in field
Native speaker of:

Portuguese
PRO pts in category: 726

26 mins confidence:

investigator's brochure brochura para o investigador

Explanation:
Diria assim... Ver exemplos.

Example sentence(s):

g) "Brochura para o investigador": a compilação dos dados clínicos e não clínicos relativos ao ou aos medicamentos experimentais, pertinentes para o estudo desse(s) medicamento(s) no ser humano;
(g) "investigator's brochure": a compilation of the clinical and non-clinical data on the investigational medicinal product or products which are relevant to the study of the product or products in human subjects;

Reference: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:...
Reference: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:...

Maria Teresa Borges de Almeida
Portugal
Local time: 05:03
Specializes in field
Native speaker of:

Portuguese
PRO pts in category: 1304

28 mins confidence:

investigator's brochure caderno de pesquisa (protocolo)

Explanation:
A term I found with one of my clients who is a pharmacist. She mentioned that this is some sort of Protocol which is required both in a ne medication and/or cosmetical product. The BROCHURA mentioned in the other two answers are related to the beginning of the protocol only.

Flavia Martins dos Santos
Brazil
Local time: 01:03
Native speaker of: Portuguese
PRO pts in category: 4

17 hrs confidence:

investigator's brochure manual do pesquisador

Explanation:
diria assim

Roberto Cavalcanti
Brazil
Local time: 01:03
Works in field
Native speaker of: Portuguese
PRO pts in category: 181

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