giudizio di notorietà
English translation: Giudizio di notorietà
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| 08:56 Jan 9, 2002 |
| Italian to English translations [PRO] Medical | |||||||
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|  Selected response from: Bilingualduo Italy Local time: 06:32 | ||||||
Grading comment
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| Summary of answers provided | ||||
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| 5 | IRB approval / IRB audit / IRB final decision on the study |
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| 4 | leave it in Italian |
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| 4 -1 | approval given by the drug evaluation committee regarding... |
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Answers
1 hr confidence: 
leave it in Italian Explanation: I would leave it in Italian. I found this definitio which might be helpful: La prima autorizzazione, indispensabile per iniziare la sperimentazione, è il cosiddetto Giudizio di Notorietà. Il Giudizio di Notorietà esprime parere relativamente all'utilizzo di un principio attivo (dose, formulazione, frequenza ) in una certa patologia o condizione clinica. Il Giudizio di Notorietà e necessario per tutti gli studi clinici dalla fase I alla fase III. In particolare il Giudizio di Notorietà per gli studi di fase II,III e IV deve essere richiesto ai Comitati Etici autorizzati, mentre per la fase I (prima somministrazione del farmaco nell'uomo) deve essere richiesto all'Istituto Superiore di Sanità Una volta ottenuto il Giudizio di Notorietà, bisogna ottenere sempre l'approvazione del Protocollo di studio da parte di tutti i Comitati Etici dei centri partecipanti alla sperimentazione. This site leaves it as it is: http://www.telethon.it/ricerca/uildm.asp HTH Cristina |
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Grading comment
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1 hr confidence: peer agreement (net): -1
peer agreement (net): -1approval given by the drug evaluation committee regarding... Explanation: the use of a specific drug in a clinical trial... In Italy, every hospital has a "Comitato Etico" which approves the use of a specific drug in a clinical trial. There is no equivalent in English. See this site (in Italian) for more in-depth explanation. http://www.telethon.it/informagene/trials-clinici-come.shtml GG |
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5 hrs confidence:
IRB approval / IRB audit / IRB final decision on the study Explanation: Elizabeth, In the US, the Committee in charge of reviewing and approving clinical studies in phase III is called the Institutional Review Board, known in the medical jargon as IRB. The documents issued by the IRB are either Inquiries to the Principal Investigator, Requests to Modify the Informed Consent, IRB Report on Audits, or Approvals to the Informed Consent. There are also several minor forms such as those required to renew the study in annual fashion. The G.N in your text probably corresponds to IRB approval. In all Eng. speaking countries there is an IRB, although the name of this board may change and be called simply "Ethics Committee for Clinical Trials" (usually different than the Ethics Committee for regular patients). See who your audience is or check with the client. Hope this helps Buon lavoro Elena I'm an MD in the US - have worked in Bologna |
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