Italian to English translations [PRO]
Medical - Medical (general) / parere semplice | | Italian term or phrase: parere semplice | | In clinical trials in italy, what is the difference between 'parere semplice' and 'parere unico' (of the Ethics Committee)? What do they mean exactly? thanks |
| garrett higginsKudoZ activityQuestions: 116 (none open) ( 15 closed without grading) Answers: 49
| Local time: 02:46
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| | English translation:collaborating EC's opinion | Explanation:
The parere unico is issued by the Coordinating Centre's EC (the centre at which the National Coordinating Investigator works), while pareri semplici are issued by the collaborating ECs (the other centres in which the trial is being conducted in Italy).
A trial has to receive a favourable parere unico before it can go ahead at any centre, although collaborating ECs are not obliged to accept it - they can refuse to permit a trial to go ahead even if the Coordinating EC has approved it (note also that the EC doesn't authorise the trial - that it is done by the Hospital's director after the EC has issued its favourable opinion).
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Note added at 27 mins (2009-11-25 09:22:54 GMT)
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clarification: the collaborating ECs can refuse to permit a trial to go ahead *in centres over which they have jurisdiction*. A negative parere semplice would not affect the trial's conduct elsewhere.
And the parere semplice is normally just called "parere". |
| Selected response from:
  Marie-Hélène Hayles
Local time: 03:46
| Grading comment thanks
4 KudoZ points were awarded for this answer |
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| Summary of reference entries provided | | liz askew |
| Discussion entries: 0 |
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Automatic update in 00:
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22 mins confidence:   peer agreement (net): +2 collaborating EC's opinion
Explanation:
The parere unico is issued by the Coordinating Centre's EC (the centre at which the National Coordinating Investigator works), while pareri semplici are issued by the collaborating ECs (the other centres in which the trial is being conducted in Italy).
A trial has to receive a favourable parere unico before it can go ahead at any centre, although collaborating ECs are not obliged to accept it - they can refuse to permit a trial to go ahead even if the Coordinating EC has approved it (note also that the EC doesn't authorise the trial - that it is done by the Hospital's director after the EC has issued its favourable opinion).
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Note added at 27 mins (2009-11-25 09:22:54 GMT)
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clarification: the collaborating ECs can refuse to permit a trial to go ahead *in centres over which they have jurisdiction*. A negative parere semplice would not affect the trial's conduct elsewhere.
And the parere semplice is normally just called "parere".
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| Reference
Reference information:
[PDF]
Rome, 17th December
File Format: PDF/Adobe Acrobat - Quick View
o da parte del comitato etico che esprime il parere unico (by the Ethics committee granting the single opinion) o da parte dei comitati etici dei centri ...
oss-sper-clin.agenziafarmaco.it/circolari...//Rilascio_dicembre_en_2008.pdf
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Note added at 1 hr (2009-11-25 10:34:53 GMT)
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I only know part of the answer, having come across this in Spanish...
| liz askew
United Kingdom
Specializes in field
Native speaker of:  English
PRO pts in category: 303
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