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Solicitud de Dictamen Único

English translation: Application for a Single Opinion

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GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Spanish term or phrase:Solicitud de Dictamen Único
English translation:Application for a Single Opinion
Entered by: LindseyH
Options:
- Contribute to this entry
- Include in personal glossary

14:36 Feb 5, 2009
Spanish to English translations [PRO]
Medical - Medical (general)
Spanish term or phrase: Solicitud de Dictamen Único
Solicitud de Dictamen Único para ensayos clínicos.
LindseyH
United Kingdom
Local time: 23:17
Application for a Single Opinion
Explanation:
refs to follow

--------------------------------------------------
Note added at 39 mins (2009-02-05 15:15:44 GMT)
--------------------------------------------------

"Dictamenes" are issued by a hospital ethics committees when a clinical trial protocol is submitted for approval. The ethics committee (or Institutional Review Board as it is called in the UK) has to approve the protocol before the trial can be conducted at that hospital.
In the case of a multi-centre trial, when it involves more than one country, there must be one ethics committee that is responsible for issuing a global report on behalf of all the ethics committees in that country.
I think that this is the "dicatmen único" that is referred to here.

http://www.clinicaldiscovery.com/readArticle.aspx?articleID=...
MRECs were introduced because EU Directive 2001/20/EC stated that for multi-centre research there must be a single opinion

http://www.ncbi.nlm.nih.gov/pubmed/17042986
Because there is not a real single opinion in Spain, as given by a single Research Ethics Committee, a key point to accelerate the MCT (multicentre clinical trial) assessment



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Note added at 52 mins (2009-02-05 15:28:39 GMT)
--------------------------------------------------

This article from the BMJ explains the situation quite clearly:

http://www.clinicaldiscovery.com/readArticle.aspx?articleID=...
U.K. Ethics Review and the R & D process – Too many Tiers?

MRECs (Multi centre research ethics committees) were introduced because EU Directive 2001/20/EC stated that for multi-centre research there must be a single opinion in each Member State.

This is a good explanation in Spanish of what the "dictamen único" is:
http://www.icf.uab.es/icbdigital/docs/dictamen.pdf


Selected response from:

Emma Goldsmith
Spain
Local time: 00:17
Grading comment
Thanks for the links. I found two identical documents in both languages.
4 KudoZ points were awarded for this answer

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Summary of answers provided
4 +1Application for a Single Opinion
Emma Goldsmith
4application for (a) single rulingCaroline Devitt
4single pronouncement request
Carlos Sorzano


  

Answers


3 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
single pronouncement request


Explanation:
my option

pronouncement[pro'nounce·ment || prə'naʊnsmənt]
s. pronunciamiento, aseveración, declaración, díctum, exteriorización, fallo, proclama, resolución

Carlos Sorzano
United States
Local time: 18:17
Specializes in field
Native speaker of: Spanish
PRO pts in category: 280
Login to enter a peer comment (or grade)

18 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
application for (a) single ruling


Explanation:
-

Caroline Devitt
Local time: 00:17
Native speaker of: Native in EnglishEnglish
PRO pts in category: 15
Login to enter a peer comment (or grade)

29 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
Application for a Single Opinion


Explanation:
refs to follow

--------------------------------------------------
Note added at 39 mins (2009-02-05 15:15:44 GMT)
--------------------------------------------------

"Dictamenes" are issued by a hospital ethics committees when a clinical trial protocol is submitted for approval. The ethics committee (or Institutional Review Board as it is called in the UK) has to approve the protocol before the trial can be conducted at that hospital.
In the case of a multi-centre trial, when it involves more than one country, there must be one ethics committee that is responsible for issuing a global report on behalf of all the ethics committees in that country.
I think that this is the "dicatmen único" that is referred to here.

http://www.clinicaldiscovery.com/readArticle.aspx?articleID=...
MRECs were introduced because EU Directive 2001/20/EC stated that for multi-centre research there must be a single opinion

http://www.ncbi.nlm.nih.gov/pubmed/17042986
Because there is not a real single opinion in Spain, as given by a single Research Ethics Committee, a key point to accelerate the MCT (multicentre clinical trial) assessment



--------------------------------------------------
Note added at 52 mins (2009-02-05 15:28:39 GMT)
--------------------------------------------------

This article from the BMJ explains the situation quite clearly:

http://www.clinicaldiscovery.com/readArticle.aspx?articleID=...
U.K. Ethics Review and the R & D process – Too many Tiers?

MRECs (Multi centre research ethics committees) were introduced because EU Directive 2001/20/EC stated that for multi-centre research there must be a single opinion in each Member State.

This is a good explanation in Spanish of what the "dictamen único" is:
http://www.icf.uab.es/icbdigital/docs/dictamen.pdf




Emma Goldsmith
Spain
Local time: 00:17
Specializes in field
Native speaker of: Native in EnglishEnglish
PRO pts in category: 855
Grading comment
Thanks for the links. I found two identical documents in both languages.

Peer comments on this answer (and responses from the answerer)
agree  cebice: correct
55 mins
  -> thanks, cebice
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