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documento de orientacao

English translation: guidance document


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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Portuguese term or phrase:documento de orientacao
English translation:guidance document
Entered by: Roxane Dow
Options:
- Contribute to this entry
- Include in personal glossary

22:13 Aug 6, 2010
Portuguese to English translations [PRO]
Science - Medical: Health Care / Names of clinical study documents
Portuguese term or phrase: documento de orientacao
From Investigator's Contract for a clinical study in Portugal:

7. O Investigador aderirá ao documento de orientação do estudo X (study name).

Could this be the Investigator's Brochure?
Roxane Dow
Local time: 07:43
guidance document
Explanation:
Sugestão.
Selected response from:

Caravelle
Portugal
Local time: 15:43
Grading comment
Thank you - I believe this is correct for this context, which is a clinical trial in Europe.
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +4guidance documentCaravelle
4 +1guidelines / guideline document
R-i-c-h-a-r-d
4investigator's brochure
Jefferson D Boyles, ELS


  

Answers


5 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
guidelines / guideline document


Explanation:
The researcher will stick to the study 'x' guidelines / guideline document.

Hope it helps!

R-i-c-h-a-r-d
Brazil
Local time: 11:43
Native speaker of: Native in EnglishEnglish

Peer comments on this answer (and responses from the answerer)
agree  xxxmediamatrix: guidelines
21 mins
  -> Cheers, have a nice weekend :)
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14 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +4
guidance document


Explanation:
Sugestão.

Caravelle
Portugal
Local time: 15:43
Native speaker of: Native in PortuguesePortuguese
PRO pts in category: 4
Grading comment
Thank you - I believe this is correct for this context, which is a clinical trial in Europe.

Peer comments on this answer (and responses from the answerer)
agree  Rebekah Fowler: "Guidance document" is used by the EMA and FDA. See http://ec.europa.eu/health/documents/eudralex/vol-10/index_e... and http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClin... for examples.
26 mins
  -> Obrigado Rebekah.

agree  Marlene Curtis
1 hr
  -> Obrigado Marlene.

agree  Claudio Mazotti
1 hr
  -> Obrigado Cláudio.

agree  Uirapuru@BR
1 day1 hr
  -> Obtigado Grandão.
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10 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
investigator's brochure


Explanation:
I have researched this (i.e., I'm not just guessing), and your first instinct was correct, especially if the study is/was a clinical trial.

In other contexts (studies involving animal models, cell cultures, etc.), "protocol" might be an appropriate translation.

Jefferson D Boyles, ELS
Brazil
Local time: 11:43
Works in field
Native speaker of: English
Notes to answerer
Asker: Hi Jefferson: Thank you for your work on this. I think your answer would be correct for a clinical trial being conducted in the U.S. Since it is being done in Portugal, and "guidance document" is a standard term for the EMA, I finally decided that this is the right translation for this context. I appreciate your help; thank you.


Peer comments on this answer (and responses from the answerer)
neutral  Rebekah Fowler: Roxanne, is there any more context to suggest that the purpose/content of the "documento de orientação differs from that of a "brochura do investigador" or "protocolo"? In PT clinical trial documents, both are standard/common terms (Infarmed, EMA, etc.)
6 hrs
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