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Investigator's brochure

Portuguese translation: brochura do pesquisador

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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
Local time: 17:08
Portuguese translation:brochura do pesquisador
Explanation:
:) Pode parecer estranho, mas é isso
Selected response from:

Clauwolf
Local time: 17:08
Grading comment
Obrigado Clauwolf, foi isso que utilizei e obrigado a todos pelas sugestões.
4 KudoZ points were awarded for this answer

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Summary of answers provided
4 +6brochura do investigador
Cris RiJoFe
5 +4brochura do pesquisador
Clauwolf
5manual do investigador
Mariana Moreira
4manual do pesquisador
Roberto Cavalcanti
4caderno de pesquisa (protocolo)
Flavia Martins dos Santos
4brochura para o investigador
Teresa Borges


  

Answers


10 mins   confidence: Answerer confidence 5/5 peer agreement (net): +4
investigator's brochure
brochura do pesquisador


Explanation:
:) Pode parecer estranho, mas é isso

Clauwolf
Local time: 17:08
Works in field
Native speaker of: Native in PortuguesePortuguese
PRO pts in category: 474
Grading comment
Obrigado Clauwolf, foi isso que utilizei e obrigado a todos pelas sugestões.

Peer comments on this answer (and responses from the answerer)
agree  Mrs Wood
3 mins
  -> obrigado

agree  Katarina Peters
8 mins
  -> obrigado

agree  Lúcia Leitão: Concordo, mas em vez de "do" colocaria "para"
16 mins
  -> obrigado

agree  Humberto Ribas
1 hr
  -> obrigado
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16 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 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: 21:08
Specializes in field
Native speaker of: Native in FrenchFrench, Native in PortuguesePortuguese
PRO pts in category: 8

Peer comments on this answer (and responses from the answerer)
agree  Susana Morais
2 mins
  -> Obrigada Susana!

agree  Ana Mafalda Costa
13 mins
  -> Obrigada Ana Mafalda!

agree  Heloisa Ferreira
20 mins
  -> Obrigada Heloisa!

agree  Maria José Tavares
20 mins
  -> Obrigada Maria José!

agree  Mary Palmer
21 hrs
  -> Obrigada Mary!

agree  Michele Santiago
1820 days
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26 mins   confidence: Answerer confidence 5/5
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: 21:08
Specializes in field
Native speaker of: Native in PortuguesePortuguese
PRO pts in category: 726
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26 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
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:...
Teresa Borges
Portugal
Local time: 21:08
Specializes in field
Native speaker of: Native in PortuguesePortuguese
PRO pts in category: 1120
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28 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
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: 17:08
Native speaker of: Portuguese
PRO pts in category: 4
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17 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
investigator's brochure
manual do pesquisador


Explanation:
diria assim

Roberto Cavalcanti
Brazil
Local time: 17:08
Works in field
Native speaker of: Portuguese
PRO pts in category: 181
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